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Tag: us department of health and human services

  • Frostbite can strike quickly. Here's what you need to know | CNN

    Frostbite can strike quickly. Here's what you need to know | CNN



    CNN
     — 

    It’s COLD. We’re talking dangerous cold. Cold that might rob you of the tips of your nose, ears, chin, fingers or toes if you’re not careful. Called frostbite, it happens when the skin and the tissue under the skin freezes, which can happen much more quickly than you might imagine.

    Frostbite is not only dependent on the outside temperature. It’s also affected by the wind chill factor. As the speed of the wind increases, our bodies cool at a faster rate, causing the skin temperature to drop. Higher altitudes can also increase the speed at which skin can freeze.

    The National Weather Service has created a wind chill chart that shows the time it might take to develop frostbite at varying temperatures and wind speed. The index was tested on human face models.

    For example, if it were zero degrees Fahrenheit (minus 17.8 degrees Celsius) and calm, your chance of frostbite would be relatively low. Add wind at 15 miles per hour, and it would take 30 minutes before frostbite set in. If the wind rose to over 50 miles per hour, it would take a mere 10 minutes for frost to bite.

    Your skin would freeze in a scant five minutes if you were out in minus 25 degrees Fahrenheit (minus 31.7 degrees Celsius) with a wind speed of just over 25 miles per hour.

    You are more susceptible to frostbite if you smoke, take medications called beta-blockers, have poor blood supply to the legs, or have diabetes or Raynaud syndrome, a condition in which strong emotions or cold temperatures cause blood vessels to spasm and block blood flow to extremities.

    Older people and people who live outside without proper clothing, heating and food are also at high risk, as are hikers and hunters who aren’t properly clothed and stay outdoors too long.

    The US Centers for Disease Control and Prevention also warns that anyone who drinks excess alcohol or uses illicit drugs is at high risk (see the CDC’s graphics below for more information). While you may feel like your body is warmer, your core temperature and blood pressure actually drop.

    And of course, you are more likely to get frostbite if you aren’t dressed properly for the weather. The CDC has a visual chart that shows the critical areas to keep covered in extreme cold.

    First degree frostbite: The first stage of frostbite is often called “frostnip” and begins with redness and a pins-and-needles feeling. Get out of the cold quickly at this time to avoid further damage to the skin.

    Moving beyond frostnip to the more dangerous stages can happen quickly.

    A mild nip on your body could be warmed up with your own body heat; try sticking those fingers into your armpit, for example. Rewarm those red toes with a soak in warm — never hot ± water for up to 30 minutes. Since you won’t be able to tell with those zapped toes, test the water with another part of the body to be sure it’s comfortable. Rewarm ears, nose and cheeks with warm cloths; resoak and reapply repeatedly.

    Be prepared for a bit of pain as the frostbitten areas come back to life. You’ll know when warming is complete when the skin is soft and all feeling has returned. But don’t use stoves or warming pads, the CDC warns. Those numb bits can’t tell the temperature, and they could easily burn as they warm up.

    The second stage of frostbite can appear as white or waxy, with numbness to feeling.

    Second degree frostbite: Superficial frostbite is the second stage. It’s known as second-degree frostbite and begins when your skin begins to turn pale white or grayish-yellow instead of red. It might even begin to appear blue. Crystals of ice are beginning to form in the skin, and it may become hard and numb to sensation. Some people say it feels “waxy.”

    Because the pain and redness are subsiding, unfortunately, people often don’t realize what is happening to them. But soon, the skin might warm and begin to swell, which is a sign that damage to tissue is occurring. This is the time at which prompt medical treatment is needed to prevent further, more serious damage.

    Immediate rewarming is key, but it should be done carefully by trained medical professionals, who will immediately wrap the injured area to protect it. At times, blisters filled with fluid can develop, and the skin can sting, burn and swell dramatically.

    The most severe stage of frostbite is shown.

    Third degree frostbite: Deep frostbite is the next stage, in which the skin can appear blue and mottled, and numb to pain and cold. Blood-filled blisters can form. Muscles next to the area might fail to work properly. At this point you are in danger of blood clots and will need anticlotting medications to increase blood flow to the area.

    Medical attention is crucial at this stage to avoid amputation of the injured tissue. Depending on the severity of the injury, the tissue can look black and feel hard after it’s rewarmed. If the tissue has died, a process called gangrene, then the dead areas may have to be excised or amputated. At times, there can also be long-lasting damage to muscles, tendons, nerves and bones in the area.

    If medical care isn’t immediately available, wrap the affected areas in sterile dressings, carefully separating injured fingers and toes from each other. But try to move the affected areas as little as possible to avoid further tissue damage.

    If a frostbitten area is warmed and then refrozen, damage can be even more severe. According to the US National Library of Medicine, if refreezing is a possibility, it might be best to delay the initial warming process until a warm location can be found. Warm drinks are best for replacing lost body fluids.

    Two more warnings from the CDC: Don’t rub with snow or otherwise massage any frostbitten areas. You’ll just make any tissue damage worse. The same applies to walking on frostbitten feet or toes, so avoid that unless absolutely necessary.

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  • Mpox in the United States Fast Facts | CNN

    Mpox in the United States Fast Facts | CNN



    CNN
     — 

    Here’s a look at mpox, formerly known as monkeypox, in the United States. In 2022, an outbreak was declared a public health emergency of international concern by the World Health Organization (WHO). The virus originated in Africa and is the cousin of the smallpox virus.

    In November 2022, WHO renames the monkeypox virus as mpox after working with International Committee on the Taxonomy of Viruses (ICTV) to rename the the virus using non-stigmatizing, non-offensive social and cultural nomenclature.

    (Source: Centers for Disease Control and Prevention)

    Mpox is a poxvirus. It generally causes pimple- or blister-like lesions and flu-like symptoms such as fever. The disease is rarely fatal.

    Mpox spreads through close contact. This includes direct physical contact with lesions as well as “respiratory secretions” shared through face-to-face interaction and touching objects that have been contaminated by mpox lesions or fluids. The virus may also pass to a fetus through the placenta.

    Anyone can become ill from mpox, but the US Centers for Disease Control and Prevention (CDC) says that more than 99% of mpox cases in the United States in the 2022 outbreak have been among men who have sex with men. However, mpox is not generally considered a sexually transmitted disease.

    Mpox is usually found in West and Central Africa, but additional cases have been seen in Europe, including the United Kingdom, and other parts of the world in recent years. Those cases are typically linked to international travel or imported animals infected with the poxvirus.

    CDC Mpox Map and Case Count

    WHO Situation Reports

    Timeline and 2022 Outbreak

    1958 – Mpox is discovered when monkeys kept for research cause two outbreaks in Copenhagen, Denmark.

    1970 – The first human case is recorded in Zaire (now the Democratic Republic of Congo).

    2003 – An outbreak in the United States is linked to infected pet prairie dogs imported from Ghana and results in more than 80 cases.

    July 16, 2021 – The CDC and local health officials in Dallas announce they are investigating a case of mpox in a traveler from Nigeria. “The individual is a City of Dallas resident who traveled from Nigeria to Dallas, arriving at Love Field airport on July 9, 2021. The person is hospitalized in Dallas and is in stable condition,” the Dallas County Department of Health and Human Services says in a statement.

    May 17, 2022 – The first confirmed US case of mpox in the 2022 outbreak is reported to the CDC in a traveler who returned to Massachusetts from Canada.

    May 19, 2022 – WHO reports that death rates of the outbreak have been between 3% and 6%.

    May 23, 2022 – The CDC announces the release of mpox vaccine doses from the nation’s Strategic National Stockpile for “high-risk people.” In the United States, the two-dose Jynneos vaccine is licensed to prevent smallpox and specifically to prevent mpox.

    May 26, 2022 – CDC Director Dr. Rochelle Walensky announces that the United States is distributing the vaccine to states with reported cases and recommends vaccination for people at highest risk of infection due to direct contact with someone who has mpox.

    June 22, 2022 – The CDC announces a partnership with five commercial laboratories to ramp up testing capacity in the United States.

    June 23, 2022 – New York City launches the first mpox vaccination clinic in the United States.

    June 28, 2022 – The US Department of Health and Human Services (HHS) and the Biden administration announce an enhanced vaccination strategy and report that more than 9,000 doses of vaccine have been distributed to date.

    July 22, 2022 – Two American children contract mpox – a first in the United States. According to the CDC, the two cases are unrelated.

    July 23, 2022 – WHO declares mpox a public health emergency of international concern, “an extraordinary event that may constitute a public health risk to other countries through international spread of disease and may require an international coordinated response.”

    July 27, 2022 – After weeks of mpox vaccines being in limited supply, more than 786,000 additional doses are made available in the United States, according to HHS.

    July 29, 2022 – New York declares a state disaster emergency in response to the mpox outbreak.

    August 1, 2022 – California and Illinois declare states of emergency. California has reported more than 800 cases, while Illinois has had more than 500, according to data from the CDC.

    August 2, 2022 – An mpox response team is created by the Biden administration. President Joe Biden names Robert Fenton from the Federal Emergency Management Agency (FEMA) as the White House national mpox response coordinator.

    August 2, 2022 – A report from Spain’s National Institute for Microbiology indicates two men, ages 31 and 44, who died from mpox in unrelated cases had both developed encephalitis, or swelling of the brain, which can be triggered by viral infections. Encephalitis is a very rare condition known to be associated with mpox. It has been reported in people with mpox in West Africa and in a patient in the United States in 2003 during the small outbreak linked to imported prairie dogs.

    August 4, 2022 – The Biden administration declares the mpox outbreak a national public health emergency.

    August 5, 2022 – A report published by the CDC finds that 94% of cases were among men who had recent sexual or close intimate contact with another man. Further, 54% of cases were among Black Americans and Latinos.

    August 9, 2022 – In an effort to stretch the limited supply of the Jynneos mpox vaccine, federal health officials authorize administering smaller doses using a different method of injection. The new injection strategy allows health-care providers to give shallow injections intradermally, in between layers of the skin, with one-fifth the standard dose size instead of subcutaneously, into the fatty layer below the skin, with the larger dose.

    August 18, 2022 – The White House announces the acceleration of the HHS vaccine distribution timeline, with an additional 1.8 million doses of the Jynneos vaccine being made available. Additional vaccines will be distributed to communities hosting large LGBTQI+ events.

    August 19, 2022 – Washington’s King County, which includes Seattle, declares mpox a public health emergency, with more than 270 recorded cases.

    September 12, 2022 – The first US death due to mpox is confirmed in Los Angeles County, California.

    May 11, 2023 – WHO declares the mpox outbreak is no longer a global health emergency.

    October 26, 2023 – CDC’s Advisory Committee on Immunization Practices, or ACIP, votes unanimously to recommend that certain individuals ages 18 and older who are at high risk for getting mpox continue to get the vaccine as a routine part of their sexual health care.

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  • Neuralink, Elon Musk’s brain implant startup, set to begin human trials | CNN Business

    Neuralink, Elon Musk’s brain implant startup, set to begin human trials | CNN Business


    New York
    CNN
     — 

    Elon Musk’s controversial biotechnology startup Neuralink opened up recruitment for its first human clinical trial Tuesday, according to a company blog.

    After receiving approval from an independent review board, Neuralink is set to begin offering brain implants to paralysis patients as part of the PRIME Study, the company said. PRIME, short for Precise Robotically Implanted Brain-Computer Interface, is being carried out to evaluate both the safety and functionality of the implant.

    Trial patients will have a chip surgically placed in the part of the brain that controls the intention to move. The chip, installed by a robot, will then record and send brain signals to an app, with the initial goal being “to grant people the ability to control a computer cursor or keyboard using their thoughts alone,” the company wrote.

    Those with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify for the six-year-long study – 18 months of at-home and clinic visits followed by follow-up visits over five years. Interested people can sign up in the patient registry on Neuralink’s website.

    Musk has been working on Neuralink’s goal of using implants to connect the human brain to a computer for five years, but the company so far has only tested on animals. The company also faced scrutiny after a monkey died in project testing in 2022 as part of efforts to get the animal to play Pong, one of the first video games.

    In May, Neuralink tweeted that it had received FDA clearance for human clinical trials, with the approval acknowledged by the agency in a statement. The opening of human trials also comes over a month after the brain chip startup raised $280 million in a fundraising round led by Founders Fund, a San Francisco-based VC firm established by Peter Thiel, the controversial billionaire who was also a co-founder at PayPal.

    “We’re extremely excited about this next chapter at Neuralink,” the company wrote at the time on X, the Musk-owned social media platform formerly known as Twitter.

    Musk has forecast human trials at the startup at least four times since 2019, yet the company didn’t seek FDA approval until 2022. At that time, the agency rejected the bid, according to a March Reuters report, citing safety concerns about parts of the implant migrating to other parts of the brain and possible brain tissue damage when the devices are removed. Musk said at a December recruiting event that Neuralink has submitted “most” of its paperwork to the US Food and Drug Administration and could begin testing on humans within six months.

    But employees told Reuters in December that the company is rushing to market, resulting in careless animal deaths and a federal investigation.

    Neuralink did not respond to CNN’s request for comment.

    Before Neuralink’s brain implants hit the broader market, they’ll need regulatory approval. The FDA put out a paper in 2021 mapping out the agency’s initial thoughts on brain-computer interface devices, noting the field is “progressing rapidly.”

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  • Biden administration suspends funding for Wuhan lab | CNN Politics

    Biden administration suspends funding for Wuhan lab | CNN Politics



    CNN
     — 

    The Biden administration has suspended funding for the Wuhan Institute of Virology following a monthslong review that determined that the Chinese research institute “is not compliant with federal regulations and is not presently responsible,” according to a memo from the Department of Health and Human Services.

    HHS, which conducted the review, also proposed barring the Wuhan Institute from doing business with the federal government going forward, according to the memo, which is dated to Monday and was first reported by Bloomberg.

    The lab has not received any federal funding from the US National Institutes of Health since July 2020, according to an HHS spokesperson.

    The determination came after the research institute failed to provide the National Institutes of Health with requested documents amid reported safety concerns at the lab.

    “This action aims to ensure that WIV does not receive another dollar of federal funding,” an HHS spokesperson said in a statement. “The move was undertaken due to WIV’s failure to provide documentation on WIV’s research requested by NIH related to concerns that WIV violated NIH’s biosafety protocols.”

    In Monday’s memorandum, HHS’s deputy assistant secretary for acquisition concludes that the Wuhan Institute’s “disregard of the NIH’s requests” and the NIH’s conclusion that the institute’s research likely violated biosafety protocols present a risk that the institute “not only previously violated, but is currently violating, and will continue to violate, protocols of the NIH on biosafety.”

    “Therefore, I have determined that the immediate suspension of WIV is necessary to mitigate any potential public health risk,” the official, whose name is redacted, writes in the memo.

    The Wuhan Institute of Virology is at the center of a theory that Covid-19 escaped from the lab in late 2019, triggering the global pandemic.

    The US intelligence community has yet to reach a conclusion about where the virus originated. The Office of the Director of National Intelligence released a declassified report last month that stated the US intelligence community could not determine whether researchers at the lab who fell ill in the fall of 2019 were infected with Covid-19, but identified safety and security issues at the lab. Many other experts say evidence suggests that the coronavirus likely emerged naturally and spread to humans in a Wuhan seafood market.

    The National Institutes of Health notified EcoHealth Alliance – a US-based organization that received a 2014 grant from NIH that was partly funneled to the Wuhan Institute – in April 2020 that it was reviewing allegations linking the Wuhan Institute to the coronavirus pandemic. And in July of that year, NIH told EcoHealth it had received reports of “biosafety concerns” at the lab.

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  • FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

    FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN



    CNN
     — 

    Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

    Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

    The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

    Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

    “Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

    The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

    If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

    At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

    “I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

    The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

    Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

    In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

    “This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

    A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

    About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

    Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

    “We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

    Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

    Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

    Murray said the lack of sufficient information from the study poses challenges for approval.

    “It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

    Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

    “I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

    Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

    Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

    “The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

    Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

    “The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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  • Two hospitals under federal investigation over care of pregnant woman who was refused abortion | CNN

    Two hospitals under federal investigation over care of pregnant woman who was refused abortion | CNN



    CNN
     — 

    The Centers for Medicare and Medicaid Services is investigating two hospitals that “did not offer necessary stabilizing care to an individual experiencing an emergency medical condition, in violation of the Emergency Medical Treatment and Labor Act (EMTALA),” according to a letter from US Health and Human Services Secretary Xavier Becerra.

    Under EMTALA, health care professionals are required to “offer treatment, including abortion care, that the provider reasonably determines is necessary to stabilize the patient’s emergency medical condition,” Becerra said Monday in his letter to national hospital and provider associations.

    The National Women’s Law Center, which said in a statement that it filed the initial EMTALA complaint on behalf of Mylissa Farmer, identified the hospitals as Freeman Hospital West of Joplin, Missouri, and the University of Kansas Health System in Kansas City, Kansas.

    The patient was nearly 18 weeks pregnant when she had a preterm premature rupture of membranes, Becerra wrote, but she was told that her pregnancy wasn’t viable.

    “Although her doctors advised her that her condition could rapidly deteriorate, they also advised that they could not provide her with the care that would prevent infection, hemorrhage, and potentially death because, they said, the hospital policies prohibited treatment that could be considered an abortion,” Becerra wrote.

    Becerra added in a statement Monday, “fortunately, this patient survived. But she never should have gone through the terrifying ordeal she experienced in the first place. We want her, and every patient out there like her, to know that we will do everything we can to protect their lives and health, and to investigate and enforce the law to the fullest extent of our legal authority.”

    Abortion is banned in Missouri, with limited exceptions, such as to save the mother’s life. State law requires counseling and a 72-hour waiting period. In Kansas, abortion is generally banned at or after 22 weeks of pregnancy, with a 24-hour waiting period and counseling required.

    Passed in 1986, EMTALA requires that hospitals provide stabilizing treatment to patients who have emergency medical conditions, or transfer them to facilities where such care will be provided, regardless of any conflicting state laws or mandates.

    Changes to state laws in the wake of the US Supreme Court decision that overturned the right to an abortion have left many hospitals and providers uncertain or confused about the steps they can legally take in such cases. HHS issued guidance last year reaffirming that EMTALA requires providers to offer stabilizing care in emergency cases, which might include abortion.

    Hospitals found to be in violation of EMTALA could lose their Medicare and Medicaid provider agreements and could face civil penalties. An individual physician could also face civil penalties if they are found to be in violation.

    HHS may impose a $119,942 fine per violation for hospitals with more than 100 beds and $59,973 for hospitals with fewer than 100 beds. A physician could face a $119,942 fine per violation.

    The National Women’s Law Center says the new actions are the first time since Roe v. Wade was overturned that EMTALA has been enforced against a hospital that denied emergency abortion care.

    “The care provided to the patient was reviewed by the hospital and found to be in accordance with hospital policy,” the University of Kansas Health System said in a statement to CNN. “It met the standard of care based upon the facts known at the time, and complied with all applicable law. There is a process with CMS for this complaint and we respect that process. The University of Kansas Health System follows federal and Kansas law in providing appropriate, stabilizing, and quality care to all of its patients, including obstetric patients.”

    Freeman Hospital did not immediately respond to CNN’s request for comment.

    An HHS spokesperson told CNN that both hospitals are working toward coming into compliance with the law.

    In the law center’s statement, Farmer said she was pleased with the investigations, “but pregnant people across the country continue to be denied care and face increased risk of complications or death, and it must stop. I was already dealing with unimaginable loss and the hospitals made things so much harder. I’m still struggling emotionally with what happened to me, but I am determined to keep fighting because no one should have to go through this.”

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  • Jordan subpoenas CDC, other federal agencies over censorship concerns | CNN Politics

    Jordan subpoenas CDC, other federal agencies over censorship concerns | CNN Politics



    CNN
     — 

    The House Judiciary Committee has sent subpoenas to the Centers for Disease Control and Prevention, the Cybersecurity and Infrastructure Security Agency, and the Global Engagement Center for documents as it continues to investigate whether the federal government pressured social media companies to censor certain viewpoints.

    The subpoenas mark an escalation in the panel’s inquiry, as House Judiciary Chairman Jim Jordan described the agencies responses to previous voluntary request in March as “inadequate” in the subpoena cover letter and said that none of the agencies have produced any documents responding to previous requests to date.

    Jordan, a Republican, has long claimed that the federal government and big tech companies have been “weaponized” against conservatives, and leads a subcommittee on that topic.

    The subpoena letters do not list any specific allegations the committee is investigating but raises the concern over censorship more broadly. The subpoenas set a document deadline of May 22 for a broad request of information and communications.

    Through the subpoenas to the CDC, CISA (which is a part of the Department of Homeland Security) and the Global Engagement Center, under the Department of State’s purview, the Judiciary panel claims to be seeking information about the extent to which the Executive Branch “pressured and colluded” with social media and other tech companies and others to “censor certain viewpoints on social and other media in ways that undermine First Amendment principles.”

    Conservative critics have said that correspondence released by Twitter owner and CEO Elon Musk late last year demonstrates a willingness by social media publishers to act on requests by government officials to suppress certain points of view. Federal officials, however, have rejected this accusation.

    “The Department of Homeland Security does not censor speech and does not request that content be taken down by social media companies,” a Department of Homeland Security spokesperson told CNN. “Instead of working with the Department, as numerous committees have done this Congress, the House Judiciary Committee has unnecessarily escalated to a subpoena. DHS will continue cooperating appropriately with Congressional oversight requests, all while faithfully working to protect our nation from terrorism and targeted violence, secure our borders, respond to natural disasters, defend against cyberattacks, and more.”

    The Judiciary panel “made no effort to work with DHS through traditional channels” a source familiar with the backchanneling between the committee and DHS said.

    Outlining the scope of the agency, the source added that CISA provides guidance on foreign influence operations, disinformation tactics and issues of election security and shares that information with state and local election officials. In the 2018 and 2020 election cycles, CISA shared potential election security related disinformation identified by local authorities with social media companies, but did not do so in the 2022 election cycle. The source emphasized, “platforms make their own decisions according to their policies and terms of service.”

    CNN has reached out to the other agencies for comment as well.

    Jordan claims that the subpoenas will help his panel determine if legislation is needed to create “new statutory limits on the Executive Branch’s ability to work with social media platforms and other companies to restrict the circulation of content and deplatform users.”

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  • A 13-year-old died in Ohio after participating in a Benadryl TikTok ‘challenge’ | CNN

    A 13-year-old died in Ohio after participating in a Benadryl TikTok ‘challenge’ | CNN



    CNN
     — 

    A 13-year-old in Ohio has died after “he took a bunch of Benadryl,” trying a dangerous TikTok challenge that’s circulating online, according to a CNN affiliate and a GoFundMe account from his family.

    Jacob Stevens was participating in a TikTok challenge with some friends at home when he ingested the antihistamine, the family donation account states. Jacob was on a ventilator for almost a week before he died, according to WSYX.

    CNN has not independently confirmed his cause of death.

    Overdosing on Benadryl can result in “serious heart problems, seizures, coma, or even death,” the US Food and Drug Administration said in a 2020 warning to the public about the deadly “Benadryl Challenge” on TikTok.

    Here’s what your teen could see on TikTok

    Jacob’s grandmother is doing anything she can “to make sure another child doesn’t go through” with the challenge, she told CNN affiliate WSYX.

    In a statement to CNN, TikTok said, “Our deepest sympathies go out to the family. At TikTok, we strictly prohibit and remove content that promotes dangerous behavior with the safety of our community as a priority. We have never seen this type of content trend on our platform and have blocked searches for years to help discourage copycat behavior. Our team of 40,000 safety professionals works to remove violations of our Community Guidelines and we encourage our community to report any content or accounts they’re concerned about.”

    The maker of Benadryl, Johnson & Johnson, has called the challenge “dangerous.”

    “We understand that consumers may have heard about an online ‘challenge’ involving the misuse or abuse of diphenhydramine,” the undated online statement reads.

    “The challenge, which involves ingestion of excessive quantities of diphenhydramine, is a dangerous trend and should be stopped immediately. BENADRYL® products and other diphenhydramine products should only be used as directed by the label.”

    “We are working with TikTok and other social platforms to remove content that showcases this behavior,” the statement added. “We will look to partner across industry and with key stakeholders to address this dangerous behavior.”

    CNN has reached out to the Stevens family and Columbus Public Health for comment.

    The FDA’s 2020 warning said the agency had “contacted TikTok and strongly urged them to remove the videos from their platform and to be vigilant to remove additional videos that may be posted.”

    Benadryl is an antihistamine used to treat symptoms such as a runny nose or sneezing from upper respiratory allergies, hay fever or the common cold. It’s safe and effective when used as recommended, the FDA said.

    “Diphenhydramine is marketed under the brand-name Benadryl, store brands, and generics. It is also available in combination with pain relievers, fever reducers, and decongestants,” the agency said.

    Consumers and parents should store Benadryl and other over-the-counter medications and prescription medicines out of the reach of children, the FDA said.

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  • FDA clears the way for additional bivalent boosters for certain vulnerable individuals | CNN

    FDA clears the way for additional bivalent boosters for certain vulnerable individuals | CNN



    CNN
     — 

    The U.S. Food and Drug Administration amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines on Tuesday, allowing people ages 65 and older and certain people with weakened immunity to get additional doses before this fall’s vaccination campaigns.

    The bivalent vaccines made by Pfizer and Moderna carry instructions for fighting both the original strain of the Covid-19 virus as well as Omicron and its spinoffs.

    They have been available in the United States since September under emergency use authorizations, or EUAs, which tightly restrict how the vaccines may be given.

    On Tuesday, the FDA changed the terms of the authorizations for those vaccines so that certain individuals could get an additional dose ahead of most others.

    Namely, adults ages 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months following their first dose.

    Most individuals with certain degrees of immunocompromise who have received a first dose of a bivalent vaccine can get a second at least 2 months later. Additional doses may be administered at the discretion of their healthcare provider.

    Dr. Peter Hotez, who co-directs the Center for Vaccine Development at Texas Children’s Hospital, has been calling on the FDA to increase access to the bivalent boosters for those who want them. He says for the most part, today’s guidance from the agency makes sense.

    “My only question is why the 65 year age cutoff? What was that based on? Ordinarily I would have preferred that it be brought down to 60 or even 50,” Hotez said in an email to CNN.

    “For those Americans who understand its importance, we should make second bivalent boosters available. Finally, we’ll soon need guidance about another annual fall booster. Presumably that information comes sometime this summer,” he added.

    For immunocompromised children ages 6 months through 4 years, eligibility for additional bivalent doses will depend on the vaccine previously received, the FDA said in a news release.

    Another big change is that most unvaccinated individuals may now receive a single dose of a bivalent vaccine, rather than mutiple doses of the original single-strain vaccines, the agency said. The FDA simplified its recommendation for unvaccinated individuals after recognizing that most Americans now have some immunity against Covid-19, even if its just through past infections.

    “Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death,” said Dr. Peter Marks, head of FDA’s Center for Biologics Evaluation and Research, in a news release.

    Children ages 6 months through 5 years who have not yet been vaccinated may now receive a two-dose series of the Moderna bivalent vaccine as their primary series, or a three-dose series of the Pfizer-BioNTech bivalent vaccine if they are 6 months through 4 years of age. Children who are age 5 may receive two doses of the Moderna bivalent or a single dose of the Pfizer-BioNTech bivalent vaccine.

    Children ages 6 months through 5 years who got started on their monovalent vaccines, can now get a dose of a bivalent vaccine, but the number of doses they qualify for will depend on the number of doses they’ve already had and what kind of vaccine they got.

    The agency stressed that most people who have gotten one dose of a bivalent vaccine are not currently eligible for a second dose.

    And they encouraged everyone who hasn’t yet gotten their first dose of a bivalent vaccine to do so, and many Americans are still in that bucket.

    Only about 17% of those eligible, less than 1 in 5 Americans, has gotten a recommended dose.

    As time has passed, adults with reduced immune function because of their age or an underlying health problem have been asking doctors whether they need another dose of the bivalent vaccines.

    The United States Center for Disease Control and Prevention has reported early data showing that the effectiveness of the bivalent vaccines, even against emergency room visits and hospitalizations, has already started to wane.

    But the agency has not been free to make what’s known as a “permissive use” recommendation about the boosters, which would allow doctors to offer additional doses to vulnerable patients because of the terms of the EUA.

    The updated terms give the CDC and its Advisory Committee on Immunization Practices (ACIP) greater freedom to recommend additional doses of the bivalent vaccines. The ACIP is holding a meeting on the Covid-19 vaccines Wednesday and is expected to endorse the FDA’s changes.

    For everyone not covered by today’s changes, the FDA says it intends to make decisions about future vaccinations after receiving recommendations on the fall strain composition from its advisory committee in June.

    Both Canada and the United Kingdom have offered another round of bivalent boosters to those at highest risk from Covid-19 this spring.

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  • Opinion: Top secrets come spilling out | CNN

    Opinion: Top secrets come spilling out | CNN

    Editor’s Note: Sign up to get this weekly column as a newsletter. We’re looking back at the strongest, smartest opinion takes of the week from CNN and other outlets.



    CNN
     — 

    In 1917, British analysts deciphered a coded message the German foreign minister sent to one of his country’s diplomats vowing to begin “unrestricted submarine warfare” and seeking to win over Mexico with a promise to “reconquer the lost territory in Texas, New Mexico and Arizona” if the US entered the world war. When it became public, the Zimmerman Telegram caused a sensation, helping propel the US into the conflict against Germany.

    “Never before or since has so much turned upon the solution of a secret message,” wrote David Kahn in his classic 1967 history of secret communications, “The Codebreakers.” The Germans had taken great pains to keep their intentions confidential, and the codebreakers in London’s “Room 40” had to do a lot of work to decipher the telegram.

    Their efforts stand in stark contrast to the ease with which secrets came tumbling out of a Pentagon intelligence network when 21-year-old Massachusetts Air National Guard cyber specialist Jack Teixeira allegedly posted hundreds of documents on a Discord chatroom known as “Thug Shaker Central.” The disclosures likely won’t start a war, but they could prove extremely damaging to the US and several of its allies, including Ukraine.

    Teixeira is one of more than one million people who have Top Secret clearance. “The Pentagon has already started taking steps to limit the number of people who have access to such sensitive information,” wrote Brett Bruen, a former US diplomat and Obama administration official. “But much more can be done. … Why do so many people, especially those working short stints in government, have access to information that can shape the fate of nations and their leaders?”

    Writing in the Financial Times, Kori Schake saw “some good news.”

    “While specific details will be incredibly valuable to Russia and other adversaries, these are not bombshell revelations: journalists had already reported Ukrainian ammunition running low; peace talks between Moscow and Kyiv were never likely; allies have long been aware that the US eavesdrops on them; and the disparaging assessment of Ukraine’s forthcoming offensive may prove no more accurate than previous predictions were.” These will not prove as damaging as the Edward Snowden and Chelsea Manning disclosures.

    But, she warned, “Technology making data ever more portable, distribution more global and communications more bespoke will make it easier to amass information and distribute it — either privately or publicly.”

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    In less than a week, the two Democrats expelled from the Tennessee House for their participation in a gun control protest were sent back to office by local officials.

    Writing for CNN Opinion, Rep. Justin Pearson noted, “This should be a chastening moment for revanchist forces in Tennessee’s legislature and across the country. Over the long haul, the undemocratic machinations employed to oust us from office are destined to fail. Dr. Martin Luther King, Jr. once famously said that the moral arc of the universe bends toward justice. Events this week demonstrated, more than ever, that this is indeed the case…”

    “Over two-thirds of Americans — including four out of 10 Republicans — support the kind of common sense gun safety laws that Rep. Jones, Rep. Johnson and I were protesting in favor of, in the wake of the senseless March 27 Covenant School massacre.”

    “And yet, calls for common sense gun reform measures fall on deaf ears in our legislature where a Republican supermajority is wildly out of step with most people’s values.”

    The politics of gun control have shifted, argued Democratic strategist Max Burns. The NRA’s internal struggles have weakened its influence while Democrats in office, who once feared touching the issue of guns, are increasingly speaking out. And they are making some progress in enacting new state laws, Burns noted.

    “The American people decisively support Democratic proposals for addressing the scourge of gun violence. Political watchers who criticized Democrats for talking too much about abortion during the 2022 midterm elections later ate crow after that once-dreaded culture war topic topped the list of voter concerns nationally…

    “Biden and the Democrats have the rare opportunity to build yet another winning coalition out of an issue once viewed as political poison.”

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    On Friday, the Supreme Court issued an order that temporarily ensured access to a key drug used in many medication abortions. The move gave the justices more time to consider the issue after a Texas federal judge suspended the US Food and Drug Administration’s approval of the abortion pill 23 years ago.

    “If abortion opponents are successful, access to the pill — reportedly used in more than half of abortions in the United States — will be severely undercut,” wrote Michele Goodwin and Mary Ziegler.

    “Beyond the dangerous precedent this sets for challenges to other important FDA-approved drugs that some political factions don’t like, the case is an alarming expression of the way right-wing activists are using junk science to bypass the will of the American public and restrict abortion…”

    “There are no grounds for challenging mifepristone’s approval, especially 23 years after the fact. The drug received extensive review — more than four years — before FDA approval. Moreover, claims that mifepristone threatens the health of those who take it are unfounded. The drug has a better safety record for use than Viagra and penicillin. Notably, it was available and used for years without incident in Europe.”

    In 1986, Nicholas Daniloff, the Moscow bureau chief for US News & World Report, was seized by Soviet authorities and locked up in Lefortovo prison. He was the last American journalist to be arrested in Russia before last month’s detention of Wall Street Journal correspondent Evan Gershkovich, who like Daniloff, speaks Russian fluently. Gershkovich has been charged with espionage but US officials have concluded that he was “wrongfully detained.”

    As David A. Andelman noted, Daniloff’s detention in prison lasted for 13 days before he was put under house arrest and then eventually swapped for an accused Soviet spy. In a conversation with Andelman, Daniloff recalled his reaction when he was imprisoned. “I felt claustrophobic, and I felt like I wanted to get out of there immediately. Of course, there was no chance of that. The door slams, and you have all these thoughts and feelings that run through you, and then you settle down and you realize you’re going to be hanging around that cell for some time.”

    Gershkovich’s family in Philadelphia received a letter, handwritten in Russian, from the reporter Friday.

    “I want to say that I am not losing hope,” he noted. “I read. I exercise. And I am trying to write. Maybe, finally, I am going to write something good.”

    The Amazon series “The Marvelous Mrs. Maisel” returns this month for its fifth and final season — and David Perry is here for it. The series brings back memories of visiting his grandparents Irma and Mordy in their “tiny rent-controlled Greenwich Village apartment,” an experience that helped shape his Jewish identity.

    “As a Jewish historian,” Perry wrote, “I worry about the tension between preserving the memory of past hardships while not locking our entire history into a tale of oppression. The moments of peace and joy are as vital as the moments of violence. In fact, it’s the periods of peace, of success, of interfaith community, that reveal the terrible truth about the violence: it wasn’t inevitable. People could have made different choices…”

    “A show like ‘The Marvelous Mrs. Maisel’ lets me revel in my personal New York Jewish heritage while also getting a little break from all the worry. It’s a warm, funny, sexy, extremely Jewish …. comedy that hits me straight in my glossy childhood memories. That isn’t to say the show isn’t also problematic — it most certainly is.”

    In the latest installment of CNN Opinion’s “Little Kids, Big Questions” series, 10-year-old Ronan wonders if animals are capable of being smarter than humans. With the help of the John Templeton Foundation, which is partnering on the project, the answer came from Jane Goodall, world renowned for her work with chimpanzees.

    “One of the attributes of intelligence is the ability to think and solve problems. In the early 1960s, I was told that this was unique to humans, and only we could use and make tools, only we had language and culture,” Goodall said. “But more and more research has proved that many animals are excellent at solving problems. Many use tools, and many show cultural differences. Some scientists believe that whales and dolphins are communicating with what may be a real language.”

    “Although the difference between humans and other animals is simply one of degree, our intellect really is amazing. …bees can count and do math, and that just shows how much we still have to learn about animal intelligence. But humans can calculate the distance to the stars.”

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    Earlier this month, a Texas jury convicted Daniel Perry of murder for fatally shooting a Black Lives Matter protester in 2020. The jury deliberated for 17 hours and decided Perry’s action couldn’t be excused under the state’s “stand your ground” law. Prosecutors argued Perry had instigated the incident and they introduced into evidence messages that suggested the shooting was not a spur-of-the-moment act but a premeditated one.

    On the evening of the jury verdict, Fox News host Tucker Carlson criticized the decision and told viewers he had invited Texas Gov. Greg Abbott on the show to ask if he would consider pardoning Perry. Others on the right called for Abbott to issue a pardon, and the governor soon responded with an announcement that he would do just that, as long as the Texas Board of Pardons and Paroles recommended that Perry should be granted one.

    “Trial verdicts are determined by judges and juries,” wrote Dean Obeidallah. “What Abbott is doing is not just wrong, it’s dangerous. His pardon, when it comes, is not what the rule of law looks like.”

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    Two of the likeliest candidates for president in 2024 haven’t officially committed yet.

    President Joe Biden says he intends to run again but has delayed making a formal announcement. And Florida Gov. Ron DeSantis is making all the moves a presidential contender usually makes, including hawking his new book and visiting New Hampshire, but he hasn’t joined fellow Republicans including former President Donald Trump, former UN Ambassador Nikki Haley and former Arkansas Gov. Asa Hutchinson in declaring.

    “DeSantis, who was neck and neck with the former president just a few months ago, may have lost a step or two in more recent polling. But his track record of successful governance in Florida should force GOP voters to think long and hard about what version of their party they want to put forward,” observed Patrick T. Brown.

    “A third Trump presidential nomination would indicate that Republican primary voters may prefer style over substance. But if they are serious about not just making liberals mad but advancing actual policy, GOP voters should consider other names, starting with the Florida governor.”

    Even without an official announcement by the president, wrote Julian Zelizer, the Biden-Harris campaign is very much under way. “By choosing to lie low while Republicans are gearing up for 2024, Biden is employing his version of what has become known as the ‘Rose Garden Strategy,’ whereby the incumbent campaigns by focusing on the business of being president and showing voters that he is the responsible figure in the race.”

    “The president’s understated strategy makes room for Republicans to stoke chaos, tear each other apart and make unforced errors while he remains above the fray for as long as possible. This strategy makes the GOP the focus of the election, allowing Biden to reinforce his message from 2020: do voters want someone who will govern and act in a serious manner or do they want a circus?”

    Gene Seymour: I am betting on Cousin Greg. But I am not a serious person (Spoiler alert)

    Frida Ghitis: Amid fallout of Macron-Xi meeting, another world leader tries his luck

    Michael Bociurkiw: How the battle for Bakhmut exposed Russia’s ‘meat-grinder’

    Peggy Drexler: Sen. Dianne Feinstein’s dilemma is a reminder of this universal question

    Christopher Howard: The overlooked problem with raising the retirement age for Social Security

    Elliot Williams: The justice system Trump and other white-collar defendants see is different than what most accused criminals get

    Phoebe Gavin: The hard lessons I learned the first time I was laid off

    Meg Jacobs: ‘Air’ celebrates those who do the hard work and get rewarded

    AND…

    Jill Filipovic recently took a domestic flight in South Africa. “Passengers and airport staff alike were friendly and polite. The airplane seat offered enough room for both of my legs and both of my arms. We took off on time and landed early. My shoes stayed on the whole time I was at the airport.”

    It was a vivid reminder of what’s possible in air travel — and of what’s usually lacking.

    Take the security system: “More than 20 years after Sept. 11, 2001, only passengers who pay for the privilege can avoid removing their shoes and laptops from their bags by submitting their personal information ahead of time and undergoing background checks.”

    Filipovic added, “Admittedly, I do pay — I don’t want to wait in a long security line, walk my stocking feet through a metal detector and have to un- and re-pack the MacBook I’ve carefully crammed into my carry-on. But the existence of pay-to-play shorter-line security options like Clear and TSA Pre-Check make clear that it is indeed possible to pre-screen a critical mass of passengers to avoid the morass of cranky people trying to pull on their shoes while re-packing their electronics.”

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  • Rival rulings on medication abortion hypercharge the post-Roe legal war | CNN Politics

    Rival rulings on medication abortion hypercharge the post-Roe legal war | CNN Politics



    CNN
     — 

    A pair of conflicting federal court rulings on Friday created arguably the most contentious and chaotic legal flashpoint over abortion access since the Supreme Court’s ruling last summer that overturned Roe v. Wade and ended the right to an abortion nationwide.

    Within less than an hour, two major rulings came down in separate, closely watched cases concerning medication abortion – in lawsuits that are completely at odds with each other.

    In one case, filed by anti-abortion activists in Texas, a judge said the FDA’s 2000 approval of mifepristone – one of the drugs used to terminate a pregnancy – should be halted. But the court paused its ruling for a week so that it can be appealed, and that appeal is already under way.

    In the second case, where Democratic-led states had sued in Washington to expand access to abortion pills, a judge ordered the federal government to keep the drug available in the 17 states, plus the District of Columbia, that brought the lawsuit.

    On their face, both cases deal with the administrative law that controls how the US Food and Drug Administration goes about regulating mifepristone. The disputes did not rely directly on the question of whether there is a right to an abortion – the question that was at the center of the Supreme Court’s ruling last June. But tucked in the Texas ruling, by US District Judge Matthew Kacsmaryk, was the idea that embryos could have individual rights that courts can consider in their rulings.

    Both cases emerge from a political environment that was unleashed by the Supreme Court’s Roe v. Wade reversal and a willingness to push the legal envelope that the Supreme Court ruling created. The abortion issue is now on a path back to the Supreme Court, as higher courts are asked to sort out the contradictory commands of Friday night’s decisions.

    Because the Texas judge has paused his ruling, it has no immediate impact on the availability of medication abortion drugs. But the next several days stand to be a dramatic and combustible legal fight over the order – a fight ratcheted up by the rival ruling in Washington.

    Besides pausing his ruling for one week, Kacsmaryk – an appointee of former President Donald Trump who sits in Amarillo, Texas – seemed to hold nothing back as he ripped apart the FDA’s approval of mifepristone and embraced wholeheartedly the challengers’ arguments the drug’s risks weren’t adequately considered.

    Kacsmaryk, whose anti-abortion advocacy before joining the federal bench was documented by a recent Washington Post profile, showed a striking hostility to medication abortion, which is the method used in a majority of the abortions in the United States.

    Leading medical organizations have already condemned his opinion and pushed back at the judge’s analysis of the safety of medication abortion.

    The judge said that the FDA failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion,” in what was a repeated invocation of “chemical abortion,” the term preferred by abortion opponents. Kacsmaryk suggested that the FDA’s data was downplaying the frequency with which the drug being mistakenly administered to someone who had an ectopic pregnancy, i.e. a pregnancy outside the cavity of the uterus. He repeated the challengers’ accusations that the FDA’s approval process had been the subject of improper political pressure.

    He said the FDA’s refusal to impose certain restrictions on the drug’s use “resulted in many deaths and many more severe or life-threatening adverse reactions.”

    “Whatever the numbers are, they likely would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety,” he said.

    Jack Resneck Jr., the president of the American Medical Association, said in a statement that Kacsmaryk’s ruling “flies in the face of science and evidence and threatens to upend access to a safe and effective drug.”

    “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation,” the AMA president said.

    Kacsmaryk’s opinion paid no heed to the argument made by the FDA’s defenders that cutting off access to medication abortion would put the health of pregnant people at risk and that it would force abortion seekers to terminate their pregnancies through a surgical procedure instead.

    Instead, the judge wrote that a ruling in the challengers’ favor would ensure “that women and girls are protected from unnecessary harm and that Defendants do not disregard federal law.”

    As he explained why the preliminary injunction – which was being handed down before the case could proceed to a trial – was justified, he said that embryos had their own rights that could be part of the analysis. That assertion goes farther than what the Supreme Court said in its June ruling, known as Dobbs v. Jackson Women’s Health.

    “Parenthetically, said ‘individual justice’ and ‘irreparable injury’ analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era,” Kacsmaryk said Friday.

    Whereas Kacsmaryk had been asked by the challengers in Texas to block medication abortion, US District Judge Thomas Owen Rice, who sits in Spokane, Washington, was considering whether abortion pills should be easier to obtain.

    Rice, an Obama appointee, granted the Democratic attorneys general who brought the lawsuit a partial win.

    They had asked Rice to remove certain restrictions – known as REMS or Risk Evaluation and Mitigation Strategy – the FDA has imposed on mifepristone, with the blue states arguing the drug was safe and effective enough to make those restrictions unnecessary.

    While Rice is rejecting that bid for now, he granted a request the states also made that the FDA be ordered to keep the drugs on the market. But Rice’s ruling only applies in the 17 plaintiff states and the District of Columbia.

    His decision maintains the status quo for the availability of abortion pills in those places and he specifically is blocking the agency from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy.”

    Rice’s opinion was a striking split screen to Kacmsaryk’s. While the Texas judge said the FDA did not adequately take into account the drug risks, Rice showed sympathy to the arguments that the rules for mifepristone’s use were too strict and that the agency should be taking a more lenient approach to how the abortion pill is regulated.

    Ultimately, he said he would not grant the Democratic states’ request that he remove some of the drug restrictions at this preliminary stage in the proceedings, because that would go well beyond maintaining the status quo while the case advances. He noted that if he had granted that request, it would also undo a new FDA rule that allows pharmacies to dispense abortion pills. That would reduce its availability and would run “directly counter to Plaintiffs’ request.”

    If Kacsmaryk’s ruling halting mifepristone’s approval is allowed to go into effect, it will run headlong into Rice’s order that mifepristone remain available in several states. Kacsmaryk’s ruling is a nationwide injunction.

    The Justice Department and Danco, a mifepristone manufacturer that intervened in the case to defend the approval, both filed notices of appeal. Both Attorney General Merrick Garland and Danco said in statements that in addition to the appeals, they will seek “stays” of the ruling, meaning emergency requests that the decision is frozen while the appeal moves forward.

    They’re appealing to the US 5th Circuit Court of Appeals, which is sometimes said to be the country’s most conservative appeals court. Yet some legal scholars were skeptical that the 5th Circuit, as conservative as it is, would let Kacmsaryk’s order take effect.

    Washington, where the blue states’ lawsuit was filed, is covered under the 9th Circuit, a liberal appellate court. But it’s unclear if the ruling from Rice will be appealed. Garland said the Justice Department was still reviewing the decision out of Washington. A so-called circuit split would increase the odds that the Supreme Court would intervene. But given how the practical impact of the two district court rulings contradict each other, the Supreme Court may have no choice but to get involved.

    The lawyer for the challengers in the Texas case, anti-abortion medication associations and doctors, said Friday evening that he had not reviewed the Washington decision, so he could not weigh in on how it impacted Kacsmaryk’s order that the drug’s approval be halted.

    “I’m not sure whether there’s a direct conflict yet and with the Washington state decision just because I haven’t read it yet, but there may not be a direct conflict,” Erik Baptist, who is an attorney with Alliance Defending Freedom, said. “But if there is a direct conflict then there may be – it may be inevitably going to the Supreme Court, but I’m not convinced that it’s necessary at this point to make that conclusion.”

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  • FDA inspection finds sterilization issues at recalled eye drop manufacturer’s facility | CNN

    FDA inspection finds sterilization issues at recalled eye drop manufacturer’s facility | CNN



    CNN
     — 

    The manufacturer of eye drops that have been linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published Friday by the US Food and Drug Administration.

    The FDA visited a Global Pharma Healthcare facility in India for an inspection that started in mid-February, 2½ weeks after the company recalled EzriCare Artificial Tears due to possible contamination.

    At the time of the recall, there were 55 reports of adverse events including eye infections, permanent loss of vision and at least one death with a bloodstream infection. As of late last month, 68 infections had been identified in 16 states, according to the US Centers for Disease Control and Prevention. There have been three deaths, eight cases of vision loss and four surgical eye removals reported.

    An 11-day inspection of the Global Pharma facility resulted in 11 observations by the FDA, including a “manufacturing process that lacked assurance of product sterility,” specifically for batches of product that were manufactured between December 2020 and April 2022 and shipped to the US.

    The EzriCare Artificial Tears product, which is manufactured by Global Pharma, is part of an outbreak of infections from bacteria called Pseudomonas aeruginosa.

    This rare drug-resistant bacteria can spread among people who don’t have symptoms – and to people who haven’t used the eye drops, according to the CDC. This type of spread is particularly common in health care settings.

    “The bacteria can spread when one patient carrying the bacteria exposes another patient, or when patients touch common items or when healthcare workers transmit the germs which is why infection control, like hand hygiene, is so important,” the agency told CNN in an email Monday.

    Several cases in the current outbreak have been identified in people who were carrying the bacteria without signs or symptoms of clinical infections, the CDC said. These cases were discovered through screenings at inpatient health care facilities that had clusters of infections.

    The particular strain of the bacteria associated with this outbreak had never before been reported in the US, and related infections have been identified at acute care hospitals, long-term care facilities, emergency departments, urgent care clinics and other outpatient facilities.

    People affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was most commonly reported.

    The FDA inspection of the Global Pharma facility is part of an ongoing compliance matter.

    “The FDA’s highest priority is protecting public health – this includes working with manufacturers to quickly remove unsafe drugs from shelves when they are identified,” the agency said in an email Monday. “The FDA continues to monitor this issue and is working with the Centers for Disease Control and Prevention (CDC) and the companies recalling these affected products. We urge consumers to stop using these products which may be harmful to their health.”

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  • CDC to warn some travelers to watch for Marburg virus symptoms as it investigates outbreaks in Africa | CNN

    CDC to warn some travelers to watch for Marburg virus symptoms as it investigates outbreaks in Africa | CNN



    CNN
     — 

    The US Centers for Disease Control and Prevention is sending personnel to Africa to help stop outbreaks of Marburg virus disease and is urging travelers to certain countries to take precautions. The CDC is also taking steps to keep infections from spreading to the United States.

    Equatorial Guinea and Tanzania are facing their first known outbreaks of Marburg virus, a viral fever with uncontrolled bleeding that’s a close cousin to Ebola. This week, the CDC urged travelers to both countries to avoid contact with sick people and to watch for symptoms for three weeks after leaving the area. Travelers to Equatorial Guinea should take enhanced precautions and avoid nonessential travel to the provinces where the outbreak is ongoing, the agency said.

    In the United States, the agency will post notices in international airports where most travelers arrive, warning them to watch for symptoms of the virus for 21 days and to seek care immediately if they become ill. They will also get a text reminder to watch for symptoms.

    The CDC is standing up a “center-led” emergency response; it’s not as all-encompassing as when the CDC stands up its Emergency Operations Center, such as for Covid-19 and mpox. But it will refocus the efforts and attention of the staff of its National Center for Emerging and Zoonotic Infectious Diseases to respond to the outbreaks, which are in two countries on opposite sides of Africa, indicating that the deadly hemorrhagic fever is spreading.

    Equatorial Guinea, on the coast in West Africa, declared an outbreak of Marburg virus disease in mid-February with cases spread across multiple provinces. As of March 22, Equatorial Guinea had 13 confirmed cases, including nine people who have died and one who has recovered, according to the World Health Organization. Nine CDC staffers are on the ground there. They have established a field laboratory and are assisting with testing, case identification and contact tracing.

    Tanzania, on the coast in East Africa, declared an outbreak of Marburg virus disease on March 21, with cases reported in two villages in the Kagera region, according to the CDC. As of March 22, Tanzania has had eight confirmed cases, including five deaths. The CDC has a permanent office in Tanzania that is assisting with the outbreak. It is sending additional staff to support those efforts.

    Marburg virus is a rare and deadly virus that causes fever, chills, muscle pain, rash, sore throat, diarrhea, weakness or unexplained bleeding or bruising. It is spread through contact with body fluids and contaminated surfaces. People can also catch it from infected animals. It is fatal in about half of cases who get it. Other countries in Africa have had to quell outbreaks before.

    In its early stages, the infection is difficult to distinguish from other illnesses, so a history of travel to either of those countries will be essential to helping clinicians spot it.

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  • FDA sketches out plan to bolster fragile US infant formula supply management | CNN

    FDA sketches out plan to bolster fragile US infant formula supply management | CNN



    CNN
     — 

    The US Food and Drug Administration announced Tuesday its initial strategy to boost and strengthen the management of the country’s supply of infant formula.

    The announcement came just ahead of a hearing of the House Oversight and Accountability Committee about what went wrong during last year’s infant formula shortage.

    Committee members and experts who testified were critical of formula makers and the FDA’s food safety program, which the agency has pledged to revamp in order to protect the nation’s food supply and promote better nutrition. Many experts are concerned that the formula shortage of 2022 could easily happen again, even with those changes.

    “While we stand here today, more than a year since the recall, it is my view that the state of the infant formula industry today is not much different than it was then,” testified Frank Yiannas, who stepped down from his role as the agency’s deputy commissioner of food policy and response in late February.

    “The nation remains one outbreak, one tornado, flood or cyberattack away from finding itself in a similar place to that of February 17, 2022.”

    A formula shortage that started in 2021 was exacerbated when the United States’ largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February and had to pause production after FDA inspectors found potentially dangerous bacteria at its Sturgis, Michigan, plant.

    A former Abbott employee filed a whistleblower complaint about the plant with the US Department of Labor’s Occupational Safety and Health Administration in February 2021. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

    The complaint was filed February 16, 2021, and was passed on to Abbott and the FDA three days later.

    Yiannas testified that because of the siloed nature of the agency, he wasn’t made aware of the complaint until February 2022. It was only then that he learned that children had gotten sick with Cronobacter after consuming powdered formula made at the plant.

    The US Centers for Disease Control and Prevention investigated at least four illnesses and two deaths in three states in connection. The agency sequenced bacteria from two of the children to compare against the samples the FDA took at the facility, but it did not find that the samples were closely related.

    Cronobacter infections are rare but can be serious and even fatal, especially in newborns. The bacteria lives in the environment, but when these infections are diagnosed in infants, they are often linked to powdered formula.

    “Clearly, I really wish, and I should have been notified sooner, so I could have initiated containment steps earlier. Had that happened, I believe we might not be here today,” Yiannas said Tuesday. “Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted or at least the magnitude lessened.”

    With more demand for other brands after the Abbott recalls, families across the country had to hunt through multiple stores for formula last year. Stock rates of baby formula stayed lower than they were the year before for much of 2022. Even in October, when rates had improved, nearly a third of households with a baby younger than 1 said they had trouble finding formula over the course of one week, according to a survey by the US Census Bureau.

    The FDA said Tuesday that its new national strategy helps ensure that the country’s supply of formula will remain constant and safe.

    The agency said it will work with the industry on redundancy risk management plans that will help companies identify possible supply chain problems. It will also continue to enhance inspections of infant formula plants by expanding and improving training for agency investigators.

    According to the strategy, the FDA will expedite review of premarket submissions for new products to prevent shortages. It will continue to closely monitor the formula supply and has developed a model to forecast any potential disruptions.

    It also plans to work closely with the US Department of Agriculture to build in more resiliency with its Special Supplemental Nutrition Program for Women, Infants, and Children program, or WIC, the nation’s largest purchaser of infant formula.

    The new strategy is just a first step; the long-term strategy is expected to be released in early 2024.

    Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said in a statement that the new strategy aims to incentivize “additional infant formula manufacturers to enter the market.”

    Many parts of the strategy are underway, the FDA said.

    “Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible,” FDA Commissioner Dr. Robert Califf said in a news release. “Now, with this strategy, we are looking at how to advance long-term stability in this market and mitigate future shortages, while ensuring formula is safe.”

    Formula stock rates are still not where they once were before last year’s crisis, Yiannas said, but the problem can’t be solved overnight. He said it was a good step for Congress to ask for a resiliency report from the industry.

    One positive development that came out of the crisis is that manufacturers are reporting formula volume to the FDA on a weekly basis even though there is no legal requirement to do so, he said.

    Historically, the FDA has focused on food safety and nutrition, not supply chain availability, but the Covid-19 pandemic opened eyes and served as the “biggest test on the US food system in 100 years,” Yiannas said. Food supply shortages made experts realize that the agency needed more intelligence on how companies’ supply chains worked.

    “Progress is being made, but it’s not being made fast enough,” Yiannas said.

    The FDA is now tracking sales and stock rates of baby formula. He said he’s talked to formula companies that say they have ramped up production, even though they might have cut back on the number of varieties of product they offer.

    The FDA said Tuesday that it has also done a study to better understand what led to the recall of infant formula at the Abbott plant. The agency had conducted a routine surveillance inspection at the plant in September 2021 and even then found problems like standing water and inadequate handwashing among employees.

    Abbott is facing additional investigations from the US Securities and Exchange Commission, the US Federal Trade Commission and the US Department of Justice as well as lawsuits from customers.

    Yiannas told the House committee Tuesday that one strategy to head off similar shutdowns would be to require manufacturers to report Cronobacter bacteria found in its products. Currently, only the Abbott plant in Michigan is required to report the bacteria as part of the consent decree that allowed it to reopen.

    The FDA said in November that it would like Cronobacter infections added to the CDC’s list of national notifiable diseases, which would require doctors to report cases to public health officials so the CDC and the FDA could keep better track of infections. Only two states have such a reporting requirement now.

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  • 19th century chastity law endangers 21st century abortion medicine | CNN Politics

    19th century chastity law endangers 21st century abortion medicine | CNN Politics

    A version of this story appears in CNN’s What Matters newsletter. To get it in your inbox, sign up for free here.



    CNN
     — 

    The Wild West of the post-Roe v. Wade legal landscape is focused on a lone federal judge in Amarillo, Texas, who could use a 19th century law to limit access to abortion medication for every American woman.

    The judge, 45-year-old Matthew Kacsmaryk, held a hearing Wednesday about whether he should impose a preliminary injunction that would require the US Food and Drug Administration to withdraw or suspend its approval of the drug, mifepristone, while a larger case progresses.

    Mifepristone is taken along with another drug, misoprostol, as part of the two-step medication abortion process. Misoprostol can be prescribed on its own, but it is considered less effective.

    Kacsmaryk, who sounded open to the idea of restricting access to mifepristone, will have to agree with some or all of these general points raised if he decides to issue an injunction:

    • That doctors who don’t perform abortions and live in Texas, where abortions are already banned, are harmed by abortions conducted elsewhere.
    • That an FDA approval conducted over the course of four years and finalized 23 years ago was so flawed that it should be rescinded.
    • That a single federal judge in Amarillo should do what no federal judge has ever done and unilaterally rescind an FDA approval.
    • That a drug, which studies suggest is on par with ibuprofen in terms of safety, is actually so harmful it should be reconsidered by the FDA.

    CNN’s Tierney Sneed wrote a longer list of takeaways from the hearing, where anti-abortion rights doctors and activist groups teed up their lawsuit in Kacsmaryk’s courtroom to further limit access to abortion care in the US.

    It’s important to note that no matter what Kacsmaryk does, it will be appealed up through the 5th US Circuit Court of Appeals and potentially to the Supreme Court.

    But perhaps the most incredible question Kacsmaryk faces is whether an 1870s chastity law named for an anti-vice crusader, Anthony Comstock, should be resuscitated and applied to the medicine that now accounts for a majority of US abortions.

    Comstock operated the New York Society for the Suppression of Vice and was a special agent of the US Postal Service. He was known for seizing contraband like contraceptives and condoms in the name of rooting out obscenity, according to the New York Historical Society.

    Mary Ziegler, a law professor at the University of California, Davis who has written about the Comstock Act for CNN Opinion, described Comstock as being “obsessed by what he saw as the decaying morals of a country preoccupied with sex.”

    Ziegler writes:

    The law he inspired barred not just the mailing of “obscene books” but also birth control and abortion drugs and devices. In the 19th and early 20th centuries, the Comstock Act was used to prohibit the mailing of many literary classics, from Geoffrey Chaucer’s “The Canterbury Tales” to works by James Joyce and Walt Whitman.

    Comstock himself proudly carried a gun and scoured the mail for cases involving information about abortion or contraception, even if a doctor provided it. By Comstock’s standard, the law was a great success: he claimed to have destroyed 15 tons of books, arrested more than 4,000 people and driven at least 15 people to suicide.

    While Congress has acted to relax elements of the Comstock Act, including to allow the mailing of contraceptives, it is still technically on the books with regard to the mailing of anything that could be used for an abortion.

    During the Covid-19 pandemic, the FDA dropped its requirement that a person obtain mifepristone in person. A prescription is still required.

    In December, the Department of Justice notified the US Postal Service that the Comstock Act did not apply as long as “the sender lacks the intent that the recipient of the drugs will use them unlawfully.”

    The FDA permanently removed the in-person requirement in January, hoping to guarantee more access to the medication after the Supreme Court ended Roe v. Wade last June.

    The group that brought the Texas lawsuit, the Alliance for Hippocratic Medicine, wants to reapply the Comstock Act and restrict the mailing of abortion medication.

    The FDA’s already exhaustive and detailed drug approval process was especially scrutinized for mifepristone, which was more commonly known as part of the RU-486 regimen when it became available to American women at the turn of the century.

    It had been available in Europe for a dozen years before that. Here’s CNN’s report from September 2000.

    That the drug works safely as a means of abortion is not really up for dispute as a medical matter after all that time, according to CNN’s Jen Christensen, who explains more about the medication in this article about mifepristone.

    Another CNN data analysis suggests mifepristone is safer than penicillin and Viagra.

    Mifepristone has a death rate of 0.0005% – five deaths for every 1 million people in the US who used it. Penicillin’s death rate is four times greater. Viagra’s is 10 times greater, according to the analysis by CNN’s Annette Choi and Will Mullery.

    Kacsmaryk had a long history of challenging laws providing greater access to reproductive rights before he became a federal judge. While he has promised to be an impartial judge, every Democrat and one Republican, Sen. Susan Collins of Maine, opposed his nomination in 2019.

    Now Kacsmaryk is the only federal judge at the courthouse in Amarillo, which almost guarantees he hears cases filed there.

    So it may be no coincidence that the group challenging use of mifepristone set up an outpost months before filing its lawsuit. The group is based in Tennessee, but one of the doctors named as a plaintiff in the lawsuit practices near Amarillo.

    However one feels about judicial shopping and whether that happened in this case, the word appears to be out that a conservative judge is alone in Amarillo and open for business.

    According to a CNN profile, Kacsmaryk has also put on hold Biden administration policies related to immigration and overseen cases related to vaccine requirements and gender identity. Last December, he halted a federal program in Texas that allowed minors to get birth control without their parents’ consent.

    That suit regarding the birth control program established in 1970 was brought by a Texas father “raising each of his daughters in accordance with Christian teaching on matters of sexuality,” which he said forbids premarital sex.

    Kacsmaryk agreed, even citing the Catechism of the Catholic Church in his decision to say “contraception (just like abortion) violates traditional tenets of many faiths, including the Christian faith Plaintiff practices.”

    His sister described him to The Washington Post as an anti-abortion rights activist and detailed her own decision to give a child up for adoption rather than seek an abortion.

    “He’s very passionate about the fact that you can’t preach pro-life and do nothing,” Jennifer Griffith told the Post. “We both hold the stance of you have to do something. You can’t not.”

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  • Takeaways from the Texas hearing on medication abortion drugs | CNN Politics

    Takeaways from the Texas hearing on medication abortion drugs | CNN Politics


    Amarillo, Texas
    CNN
     — 

    Over the course of about four hours of arguments, a federal judge in Texas asked questions that suggested he is seriously considering undoing the US Food and Drug Administration’s approval of a medication abortion drug and the agency’s moves to relax the rules around its use.

    But the judge, US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, also indicated he was thinking through scenarios in which he could keep the drug’s 2000 approval intact while blocking other FDA rules.

    Anti-abortion doctors and medical associations are seeking a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, and that would block the agency’s more recent regulatory changes making the pills more accessible.

    Here are takeaways from the hearing:

    Kacsmaryk showed a particular interest in the arguments by the abortion opponents that the FDA approved mifepristone in an unlawful way.

    He zeroed in on a claim by the abortion foes that the studies that the FDA looked at when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.

    Erik Baptist, attorney for the challengers, alleged that those studies all featured patients who received ultrasounds before being treated with the drug, which is not among the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “examining oranges and declaring apples to be safe.”

    Kacsmaryk returned to that “apples to oranges” argument several times throughout the hearing.

    Justice Department attorney Daniel Schwei defended the FDA’s approach, arguing that the relevant law gives the FDA discretion to determine what studies are adequate for approving a drug’s safety. He also said the challengers’ claims were factually flawed, because the FDA also was looking at studies where the patients did not receive an ultrasound.

    Kacsmaryk was similarly focused on a claim by the plaintiffs that the FDA violated the law in the special, accelerated process that it used to approve mifepristone in 2000.

    At one point the judge revealed in the hearing that he had downloaded a list of the other drugs the FDA had approved through the process. He ticked through the list of drugs, which were made up mostly of treatments for HIV and cancer, and he asked the Justice Department for its “best argument” for why mifepristone fit into the list.

    One of the sharpest questions from the judge was whether the anti-abortion activists could point to another analogous case when a court intervened in the way he is being asked to intervene here.

    Baptist conceded there was none and blamed FDA delays in addressing citizen petitions and challenges. Later in the hearing, Baptist raised other times the FDA had suspended or withdrawn drugs based on court cases in other contexts, arguing those cases showed that Kascmaryk had the authority to grant the plaintiffs’ request.

    Attorneys for the defendants – which include both the FDA and a drug company that manufactures mifepristone and intervened in the case – pushed back on those examples. They said that the plaintiffs were relying on patent cases, where the dispute was between a brand name drug and a generic counterpart, and those examples were not analogous here.

    The medication abortion lawsuit targets actions the FDA took around medication abortion pills before last summer’s Supreme Court reversal of Roe v. Wade’s abortion rights protections.

    While that decision, known as Dobbs v. Jackson Women’s Health Organization, didn’t play a major role in Wednesday’s arguments, the judge referenced it and suggested it could have an impact on his thinking about the case.

    He brought up Dobbs early on in the hearing and raised it specifically in connection with a friend of the court brief filed by 22 GOP-led states supporting the challengers.

    The judge noted that the red states’ brief argued that the FDA’s actions were infringing on their state laws concerning abortion pills.

    He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that has “changed the landscape” around the relationship between state and federal government concerning abortion policy.

    Hawley agreed, calling it a “sea change.”

    If Kacsmaryk has any sore feelings over the blow up around his efforts to keep Wednesday’s hearing plans quiet, he didn’t show them at the proceedings.

    When questioning both sides of the case, Kacsmaryk had a restrained, straight-forward tone. He had occasional follow-up questions for the plaintiffs, but did not aggressively push back on their arguments. The substance of his questions for the FDA’s defenders was more skeptical, but he kept with the measured approach in his questioning, and avoided any pushiness when grilling the government and the drug company about the approval process.

    At the end of the hearing, he thanked the parties, as well as those who filed dozens of friend of the courts briefs, for their “superb” briefing. He also acknowledged the logistical hurdles the lawyers at the hearing went through to get to his courthouse in Amarillo, which is a several hours’ drive from Texas’ biggest cities.

    Left unmentioned by the judge was the fact that he tried to delay the announcement of the hearing until the evening before, which would have made it difficult for members of the public and the media to attend Wednesday’s proceedings. When there was blowback to The Washington Post reporting about his plan – laid out in a private teleconference with attorneys where he pointed to death threats and harassment that had been directed to the courthouse staff – he announced the hearing on Monday.

    The courtroom was open to the public, but only with limited seating: 19 seats for reporters and 19 for members of the public. By 6 a.m. CT Wednesday there were already lines outside the courtroom to claim those seats. Those attendees were not allowed to bring electronics in with them, and if they left the courthouse, they were not allowed back in.

    Kacsmaryk warned at the beginning of the hearing that anyone who disrupted the proceedings would be immediately removed without warning. But there were no such disruptions.

    Kacsmaryk wrapped up the hearing without any explicit timeline for when he’ll rule, telling the parties he would issue an order and opinion “as soon as possible.”

    While he was arguing, Schwei, the DOJ attorney, requested that the judge – if he were to rule against the FDA – to immediately put that ruling on pause so it could be appealed. The judge stopped short of promising an automatic stay in the event of an adverse ruling, but he acknowledged he understood what DOJ was asking for.

    An appeal would first go to a panel of three judges of the 5th US Circuit Court of Appeals, arguably the most conservative appeals court in the country. The panel’s decision could then be appealed either to the full 5th Circuit or the US Supreme Court.

    Beyond these procedural questions, Kacsmaryk seemed to be grappling with the practical impact of a ruling in favor of the plaintiffs. He asked plaintiffs’ attorneys, the DOJ lawyers and the attorneys for the drug company Danco whether it would be possible for him to block some but not all of the FDA actions the challengers were targeting. He returned to the question again when the plaintiffs were back up for the rebuttal.

    He also pressed Baptist, the attorney for the abortion opponents, on whether the plaintiffs were seeking an order that the FDA begin the withdrawal of the drug – a process that would take months – or if they thought the judge could directly take if off the market.

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  • FDA advisers narrowly vote in favor of Pfizer’s RSV vaccine for older adults, despite possible safety concerns | CNN

    FDA advisers narrowly vote in favor of Pfizer’s RSV vaccine for older adults, despite possible safety concerns | CNN



    CNN
     — 

    Vaccine advisers to the US Food and Drug Administration narrowly voted Tuesday in favor of Pfizer’s RSV vaccine for adults over the age of 60, paving the way for approval of the first nation’s RSV vaccine, despite some safety concerns.

    The committee members voted 7-4, with one abstention, that there is adequate data to support the safety and effectiveness of Pfizer’s vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus among older adults.

    The FDA, which typically follows the independent committee’s recommendations, is scheduled to decide on approval of the vaccines by May, ahead of RSV’s typical winter surge. The US Centers for Disease Control and Prevention must then recommend the shot before it becomes available to the public.

    Pending those steps, Pfizer’s vaccine – along with GSK’s candidate shot, which will be voted on by the FDA advisory committee on Wednesday – would be the first approved RSV vaccines for adults 60 or older.

    RSV is a highly contagious virus that causes flu-like illness in people of all ages that increases in severity with age. It’s is responsible for an estimated 177,000 hospitalizations and 14,000 deaths per year among adults 65 or older, according to the CDC.

    The Pfizer vaccine was 66.7% effective at preventing moderated lower respiratory tract illness with two or more symptoms and 85.7% effective at preventing illness with three or more symptoms, according to an FDA briefing document.

    Although a majority of the committee voted in favor of the vaccine, some members expressed concerns about the vaccine’s “important potential risk: of Guillain-Barre syndrome. Two adults among the 20,000 vaccine recipients in Pfizer’s Phase 3 clinical trial developed symptoms consistent with the rare neurological disorder within nine days of receiving the shot.

    “It seems to me that one case is a red flag. Two cases is very concerning, and it’s concerning to me that Pfizer doesn’t think that there are any safety concerns,” said Dr. Marie Griffin, professor of health policy at Vanderbilt University Medical Center, who voted that the data demonstrated the vaccine was effective but not safe.

    The FDA has recommended that Pfizer conduct a safety study for further evaluation of Guillain-Barre and other immune-mediated demyelinating conditions after potential vaccine approval, and the company has agreed.

    Dr. Daniel Feikin, respiratory disease consultant, who voted that the vaccine was both safe and effective, said that post-marketing safety surveillance will be “critical.”

    Some of the vaccine advisers wanted to see more data on effectiveness against hospitalization or death, especially among high-risk people such as older adults or those with other health conditions.

    “I think the data does support the effectiveness of this vaccine. It’s just the population was underrepresented by people who could most benefit from the vaccine,” Griffin said.

    The available safety and efficacy data from Pfizer’s clinical trial is from the first of two RSV seasons. Some of the experts said that the vote is premature and that they would like to see more data.

    “I’m desperately eager to have a vaccine that works for RSV. This has been a terrible disease my whole career. I would love to see it. No doubt about it,” said Dr. Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City, who voted that the data demonstrated that the vaccine was safe but not effective.

    Portnoy says that waiting for a second season of data would provide more robust numbers and complete analysis.

    “It’s not an emergency use authorization. We can take the time to finish the studies and get the information we need before licensing this product going forward. So I remain a little bit skeptical, given the data that we have.”

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  • 12 blue states sue FDA, saying it’s too strict in limiting abortion drugs as legal battle over mifepristone heats up | CNN Politics

    12 blue states sue FDA, saying it’s too strict in limiting abortion drugs as legal battle over mifepristone heats up | CNN Politics



    CNN
     — 

    Twelve states led by liberal attorneys general announced Friday that they had sued the Food and Drug Administration, saying its limits on mifepristone, one of the two drugs used for medication abortion, are too strict.

    The suit is a possible hedge by states waiting to see how a federal judge in Texas rules in a lawsuit brought by anti-abortion groups seeking to block the FDA’s approval of mifepristone altogether. Conflicting rulings could mean the Supreme Court is asked to sort out the issue.

    RELATED: How a medication abortion, also known as an ‘abortion pill,’ works

    “The federal government has known for years that mifepristone is safe and effective,” Washington state Attorney General Bob Ferguson said in a statement. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.”

    Mifepristone was first approved in 2000 and medication abortion accounts for more than half of the abortions in the US. It is the first drug, followed by misoprostol, in the medication abortion regimen. Patients and providers must sign agreements stating the drug will be used to end a pregnancy, and pharmacies must have special certification.

    The lawsuit was filed in federal court in the Eastern District of Washington state. The states in the lawsuit are: Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.

    A lawsuit seeking to block the use of medication abortion nationwide could receive an initial decision at any moment, after the plaintiffs in the case submitted to the court on Friday their final brief on the challenge.

    The lawsuit, filed in November by anti-abortion advocates against FDA, challenges the two-decade-old approval of mifepristone, the first drug in the medication abortion process.

    A decision by US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, in favor of the plaintiffs could have far-reaching consequences since medication abortion now makes up a majority of abortions obtained in the US.

    In the filing submitted Friday, the anti-abortion advocates rehashed many of the arguments they made in earlier briefs. Its submission means that Kacsmaryk could soon rule on a motion by the plaintiffs to temporarily block use of the medication. The judge had previously said that once the February 24 filing deadline ended, “briefing will then be closed on the matter, absent any ‘exceptional or extraordinary circumstances.’”

    Kacsmaryk, however, could also call for a hearing, or ask for additional responses.

    The defendants in the case – the FDA and Danco, which makes mifepristone – argued in separate briefs to the court that a decision against the drug’s approval would be unprecedented and would shutter the drugmaker’s business.

    Reproductive rights advocates have stressed that a ruling in favor of the plaintiffs would be devastating, with NARAL Pro-Choice America saying in a statement that if the drug is yanked from the market, “64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight.”

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  • What to know about the lawsuit aiming to ban medication abortion drug mifepristone | CNN Politics

    What to know about the lawsuit aiming to ban medication abortion drug mifepristone | CNN Politics



    CNN
     — 

    A federal judge may rule later this month on a lawsuit seeking to block the use of medication abortion nationwide, in the biggest abortion-related case since the Supreme Court overturned Roe v. Wade last year.

    The lawsuit, filed in November by anti-abortion advocates against the US Food and Drug Administration, targets the agency’s 20-year-old approval of mifepristone, the first drug in the medication abortion process

    Medication abortion, which now makes up a majority of abortions obtained in the US, has become a particularly acute flashpoint in the fallout from the Supreme Court’s decision last year overturning Roe v. Wade.

    US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, has extended the briefing deadline in the case until February 24.

    Reproductive rights advocates say that if Kacsmaryk sides with the plaintiffs, “it would eliminate the most commonly used method of abortion care,” according to NARAL Pro-Choice America.

    Here’s what to know about the lawsuit:

    The lawsuit, filed last year by a coalition of anti-abortion national medical associations under the umbrella of the “Alliance for Hippocratic Medicine” and several doctors, is seeking a number of actions by the court, chief among them a preliminary and permanent injunction ordering the FDA “to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs and to withdraw defendants’ actions to deregulate these chemical abortion drugs.”

    “After two decades of engaging the FDA to no avail, plaintiffs now ask this court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen,” the complaint reads.

    The FDA responded to the lawsuit last month by asking the judge to deny the motion for a preliminary injunction, arguing that issuing one in the matter “would upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”

    The agency also says a ruling against it would set a dangerous precedent.

    “More generally, if longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the FDA wrote.

    “A preliminary injunction would interfere with Congress’s decision to entrust FDA with responsibility to ensure the safety and efficacy of drugs. In discharging this role, FDA applies its technical expertise to make complex scientific determinations about drugs’ safety and efficacy, and these determinations are entitled to substantial deference.”

    Danco, which makes mifepristone, also made a similar request to the FDA’s in a court filing, stressing that the lawsuit could decimate the company’s business.

    “Danco is a small pharmaceutical company. It sells one drug: Mifeprex,” lawyers for the company wrote in court papers. “Entering the mandatory preliminary injunction plaintiffs seek would force FDA to withdraw approval for Danco’s only product, effectively shuttering Danco’s business.”

    “Congress entrusts decision-making like this with the FDA. And they’re coming in trying to overrule that, saying this medication is unsafe because women bleed. Well, that’s part of having an abortion. It’s also part of having a pregnancy,” said Ryan Brown, an attorney representing Danco in the case. “The bottom line being that they just want to do away with abortion across the board and for any reason.”

    Kacsmaryk was appointed to the court in 2017 by then-President Trump and was confirmed by a 52-46 vote in 2019.

    Since then, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, presiding over 95% of the civil cases brought in Amarillo, Texas.

    In December, Kacsmaryk put on hold the Biden administration’s most recent attempt to end the so-called “Remain in Mexico” program. And he has overseen Texas cases challenging vaccine mandates, the gender identity guidance issued by the US Equal Employment Opportunity Commission and the administration’s limits on the use of Covid-19 relief funds for tax cuts.

    Before joining the court, Kacsmaryk served as deputy general counsel at the First Liberty Institute, a nonprofit religious liberty legal group, where he worked mainly on “religious liberty litigation in federal courts and amicus briefs in the US Supreme Court,” according to his White House biography.

    The case is being closely watched by a number of interested parties, including Republican and Democratic state attorneys general. On Friday, two different multi-state coalitions filed amicus briefs with the court urging them to act one way or another in the matter.

    A coalition of 22 Democratic attorneys general urged Kacsmaryk to deny the motion for a preliminary injunction, writing in court papers that “annulling – or even merely limiting – any of the FDA’s actions relating to medication abortion would result in an even more drastic reduction in abortion access across the entire nation, worsening already dire outcomes, deepening entrenched disparities in access to health care, and placing a potentially unbearable strain on the health care system as a whole.”

    And a coalition of 22 Republican attorneys general asked the court to issue the preliminary injunction, arguing the FDA exceeded its authority when it approved the medication.

    “State laws on chemical abortion thus account for the public interests at issue – and they do so with the benefit of democratic legitimacy (and legal authority). The FDA’s actions can make no such claim. By obstructing the judgments of elected representatives, the agency has undermined the public interest,” they wrote.

    Abortion rights advocates have sounded the alarm on the case, stressing that a ruling by Kacsmaryk in favor of the plaintiffs would affect every corner of the country since the lawsuit is targeting a federal agency.

    “If FDA approval of mifepristone is revoked, 64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight,” NARAL said in a statement on Friday, pointing to internal research.

    “This research reveals the high stakes of this lawsuit, and we can only expect the worst from this Trump-appointed federal judge. Americans want access to abortion, but anti-choice bad actors are dead set on restricting reproductive freedom by any means possible,” said Angela Vasquez-Giroux, the group’s vice president of communications and research.

    And activists are mobilizing in Texas around the issue, with the Women’s March planning to hold a rally at the federal courthouse in Amarillo, Texas, on Saturday.

    “We’ve said it before: the fight for reproductive rights now lies in the states, and legal challenges like these are just the latest example of how our fight is bigger than Roe,” said Rachel Carmona, the executive director of Women’s March.

    On Thursday, Kacsmaryk told the plaintiffs that they had until February 24 to respond to a recent filing by the Danco, writing in an order that following the deadline, “briefing will then be closed on the matter, absent any ‘exceptional or extraordinary circumstances.’”

    On Friday, the plaintiffs in the case submitted one response to the FDA’s filing. But the deadline extension means that after the plaintiffs submit a separate response to Danco, the case is ripe for judgment since all required briefings will have been filed.

    Kacsmaryk can rule at any time after that, though he could also call for a hearing, or ask for additional responses as well.

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  • More than 400 products including breakfast sandwiches and fruit cups recalled due to possible Listeria contamination | CNN

    More than 400 products including breakfast sandwiches and fruit cups recalled due to possible Listeria contamination | CNN



    CNN
     — 

    More than 400 food products sold under dozens of brand names were recalled due to possible Listeria contamination, the US Food and Drug Administration announced Friday.

    The recall by Fresh Ideation Food Group LLC includes ready-to-eat sandwiches, salads, yogurts, wraps and other products sold in nine states and Washington, DC, from January 24 through January 30.

    The Baltimore company said Friday that no illnesses have been reported so far.

    “The recall was initiated after the company’s environmental samples tested positive for Listeria monocytogenes,” Fresh Ideation Food Group said in its recall announcement.

    Eating Listeria-contaminated food can cause a serious infection that can lead to symptoms including fever, headache, diarrhea and vomiting, according to the US Centers for Disease Control and Prevention.

    It’s most likely to sicken pregnant women and their newborns, adults aged 65 or older, and people with weakened immune systems, according to the CDC. “An estimated 1,600 people get listeriosis each year, and about 260 die,” the agency says.

    The recalled foods were distributed in Connecticut, the District of Columbia, Maryland, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania, South Carolina and Virginia, according to the FDA.

    The products – which included items like bacon, egg and cheddar muffins, breakfast croissants, tuna and chicken sandwiches, and fruit cups – were sold in stores, vending machines and by transportation providers, according to the company.

    “All recalled products have a Fresh Creative Cuisine label and/or identifier on the bottom of the label with the Fresh Creative Cuisine name and a fresh through or sell through date ranging from January 31, 2023 through February 6, 2023,” the company said.

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