Tag: pharmaceutical industry

Surveillance plane helping take fentanyl pills off the streets faces extinction | CNN Politics

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Washington
CNN
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GOP Rep. Adam Kinzinger, who also serves as a pilot in the Air National Guard, is sounding the alarm about plans to cut funding for a little-known military surveillance aircraft that law enforcement officials tell CNN is an essential tool for dismantling drug trafficking organizations and has helped them take tens of thousands of illegal fentanyl pills off the streets last month alone.

Kinzinger is among a small group of Air National Guard pilots who operate the twin-engine RC-26 aircraft and have helped law enforcement agencies target large shipments of fentanyl that are flowing into the US from across the border.

But despite being described as an essential asset for law enforcement officials on the ground as they carry out raids and serve search warrants, the aircraft currently finds itself on the chopping block as Air Force leaders are planning to scrap the program, he told CNN.

“Law enforcement lives have been saved by having this asset available,” according to Kinzinger. “We can see anything weird that’s going to happen,” he said, adding that pilots can also follow suspects with their aerial camera without them knowing, allowing agents to maintain the element of surprise.

“We’ve been saving it every year piecemeal,” he said. “The guard has made it very clear. It’s gone in April.”

Law enforcement officials from around the country and National Guard pilots who fly the RC-26 have appealed directly to Air Force leaders in Washington to keep the plane or provide a capable replacement, according to multiple sources familiar with those discussions.

But despite self-imposed limits to the types of operations that can be flown by RC-26 National Guard pilots, Air Force leaders have now decided they no longer want to fund piloted reconnaissance assets for border and counter-drug missions, claiming unmanned drones can be offered up to fill that need, Kinzinger said.

Supporters of the aircraft like Kinzinger say, in reality, the Air Force does not currently have a plan to replace the capabilities provided by the RC-26 if the program is shuttered.

The Air Force has determined that divestment of the RC-26 “leaves no capability gap” and the service possesses sufficient “Intelligence, Surveillance and Reconnaissance assets” to support the needs of law enforcement authorities, Air Force spokesperson Ann Stefanek told CNN in response to questions about the future of the aircraft.

A law enforcement official who spoke to CNN under the condition of anonymity to speak frankly about his opposition to the Air Force’s plans to get rid of the aircraft, said doing so would take away the biggest advantage officers have over drug trafficking organizations that are currently “flooding the market” with large quantities of fentanyl and killing swaths of Americans in the process.

“I know the Air Force is trying to say there are other options … but they don’t have the same capabilities,” the law enforcement official, who has routinely requested assistance from Air National Guard pilots operating the RC-26, said.

“It would be a great loss for us in law enforcement,” he added, noting it allows police departments to work more cases and spend less money on things like overtime for officers.

While the RC-26 is used for a variety of missions, it has proven to be very effective in helping law enforcement agencies not only seize large amounts of fentanyl but also arresting and building cases against violent drug traffickers bringing the deadly substance into the US.

Outfitted with a range of surveillance gear, including infrared imaging systems and secure radio communications, the Air Force’s small fleet of RC-26 aircraft has played a prominent role in several recent operations targeting illicit shipments of fentanyl by serving as the preverbal eye-in-the sky for agents and officers on the ground, according to current and former officials.

An agent or police officer is often on-board the aircraft to direct the pilot where to go and, working in tandem, they are able to collect information to help inform the decision-making of law enforcement officials on the ground in real time as they execute search warrants and conduct raids.

Over the last two weeks in Arizona, the relatively obscure turboprop plane was involved in three separate fentanyl seizures of 22,500 pills each, according to law enforcement data obtained by CNN.

Each seizure prevented 10,000 potential deaths, according to a US official familiar with the operations, who noted that the DEA says four pills in 10 have a lethal amount of fentanyl in them.

But despite proving itself to be a valuable asset for drug interdiction, particularly at a time when the Biden administration is facing increasing pressure to stop the flow of fentanyl coming into the US from across the border, funding for the RC-26 aircraft is again on the chopping block.

Air Force officials believe that the relatively small amount of money used to keep the current fleet of 11 RC-26 planes in the air would be better spent elsewhere. If a House amendment to provide more funding for the aircraft fails to make it through conference and is not included in Congress’ next defense spending bill, the plane will be “gone in April,” according to Kinzinger.

The cost of maintaining all 11 RC-26s is between $25 and $31 million per year, according to a source familiar with the program, who note that is a “less than a drop in the bucket” considering the annual defense spending bill ranges in the hundreds of billions of dollars.

Kinzinger has sent a letter to the Armed Services Committees requesting they keep the current language related to funding for the RC-26 in its next defense spending bill, which would keep the aircraft around for at least one more year and require an independent assessment of how the National Guard could replace it, with a cost analysis.

But even if that happens, the aircraft’s long-term survival remains in question, as does the future success of the specialized missions it currently flies.

Kinzinger is not alone in his support of the RC-26. CNN spoke with current and former law enforcement officials working in what are known as High Intensity Trafficking Areas who were adamant that the plane is a critical tool for stopping the flow of illicit drugs into the US.

“I think of the RC-26 as my state bird,” said Rand Allison, a recently retired narcotics officer who spent over a decade working with RC-26 pilots as part of federal task forces focused on intercepting shipments of illicit drugs.

Heightened public awareness about the dangers of fentanyl, bipartisan concerns and law enforcement statistics obtained by CNN also underscore how the RC-26 remains relevant despite claims by some air Force officials that it is too old.

For example, data provided to CNN by the Southern Nevada High Impact Narcotics Task Force shows law enforcement agencies have used the RC-26 to seize 134,009 fentanyl pills and 15.7 pounds of pure fentanyl powder this year alone – a dramatic increase compared to the roughly 67,000 pills and 2.7 pounds of powder seized in 2021.

In 2020, the task force documented its first seizures of fentanyl pills and powder, underscoring how the dramatic rise in law enforcement operations focused on these trafficking operations in particular.

If the RC-26 program is ultimately scrapped, law enforcement officers would lose their best asset for dismantling trafficking operations bringing fentanyl into the US from across the border, Allison told CNN.

The RC-26 aircraft was also used in three separate drug busts over the last three weeks where law enforcement agencies seized more than 60,000 fentanyl pills in total, according to federal drug task force data obtained by CNN.

The first operation took place on October 18 in Las Vegas, Nevada, where the DEA seized 21,500 fentanyl pills.

Exactly one week later, agents with the Department of Homeland Security Investigations division carried out the bust in Tucson that yielded more than 25,000 pills. The next day, a HIS team in Phoenix, Arizona seized an additional 5,000 pills and are building a much larger case, according to a law enforcement official familiar with operation.

Still, one law enforcement official who regularly works with Air National Guard pilots to conduct counter-drug operations acknowledged feeling like they are “winning many battles but losing the war when it comes to fentanyl,” making the RC-26’s survival even more imperative.

Over the last eight years, Kinzinger has been at the forefront of efforts to save his plane from extinction and preserve its ability to fly the type of missions that have endeared it to law enforcement officials across various agencies.

Now, the RC-26 is again at risk of being phased out due to the shifting priorities of Air Force leaders that do not include flying border or counter-drug missions, according to the Republican lawmaker, who opted not to run for re-election but is using the final months of his time in Congress, in part, to advocate for the aircraft’s survival.

If that happens, the Air Force will also lose more than 60 Air National Guard pilots who are trained to fly the RC-26, Kinzinger added, noting the service is already suffering from a pilot shortage.

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November 6, 2022
Indonesia bans sale of all cough syrups after 99 child deaths | CNN

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Jakarta, Indonesia
CNN
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Indonesia has halted the sale of all syrup and liquid medicines following the deaths of nearly 100 children and an unexplained spike in cases of acute kidney injuries.

The ban, announced by the country’s Health Ministry on Wednesday, will remain until authorities complete an investigation into unregistered medical syrups suspected of containing toxic ingredients.

Health Ministry spokesperson Mohammad Syahril said 99 deaths and 206 cases of acute kidney injuries in children, mostly under the age of 6, were being investigated.

“As a precaution, the ministry has asked health workers in health facilities not to prescribe liquid medicine or syrup temporarily,” he said. “We also ask that drug stores temporarily stop all sales of non-prescription liquid medicine or syrup until our investigations are completed.”

The ban comes after the World Health Organization (WHO) linked four Indian-made cough syrups to the deaths of up to 70 children suffering acute kidney failure in The Gambia, West Africa. Earlier this month Indian authorities shut down a factory in New Delhi where the medicines were made.

WHO suspects that four of the syrups made by Maiden Pharmaceuticals Limited – Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup and Magrip N cold syrup – contained “unacceptable amounts” of chemicals that could damage the brains, lungs, livers and kidneys of those who take them.

The syrups being used in The Gambia were not available in Indonesia, according to the Southeast Asian country’s food and drugs agency.

However, on Thursday, Indonesian Health Minister Budi Gunadi Sadikin said ethylene glycol and diethylene glycol – which are more usually found in products like antifreeze, paints, plastics and cosmetics – had been detected in syrups found in the homes of some child patients.

“(The chemicals) should not have been present,” Budi said.

He added that the number of acute kidney failure cases could be higher than reported and his ministry was taking a conservative approach by banning the sale of all syrups.

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October 20, 2022
New York City announces its largest fentanyl seizure in history, eclipsing record bust from last month | CNN

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CNN
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Days after federal officials announced the largest fentanyl seizure in New York City history, an even greater quantity of the highly addictive substance has been found, authorities say.

Two people have been arrested and charged with multiple drug and firearm charges in connection to the seizure on October 7 at a Bronx apartment building, prosecutors said in a news release.

Authorities found roughly 300,000 rainbow-colored fentanyl pills inside two closets in the apartment, and more than 22 pounds of the drug in powdered form were wrapped in clear plastic packaging in multiple rooms, according to the Office of the Special Narcotics Prosecutor for the City of New York. The total sum of the drugs is worth about $9 million in street value, officials said.

The historic seizure saved lives, according to DEA Special Agent in Charge Frank Tarentino.

“Hundreds of thousands of lethal pills were lying in wait in a Bronx apartment to be unleashed onto our streets. In today’s world, the potential to overdose is dangerously high,” Tarentino said. “There is no quality control in these fake pills and it only takes two milligrams of fentanyl to be lethal.”

The seizure comes after federal officials announced last week that a woman has been charged with concealing about 15,000 rainbow-colored fentanyl pills in a Lego box as part of a drug trafficking scheme in September. That seizure at the time was also deemed the largest of fentanyl in New York City’s history.

Fentanyl is a synthetic opioid that’s highly addictive. It can be up to 50 times stronger than heroin and 100 times stronger than morphine, the US Centers for Disease Prevention and Control said.

Rainbow fentanyl comes in bright colors and can be used in pill form or powder.

“Rainbow fentanyl is the latest threat we face in our fight against the opioid epidemic that sadly continues to ravage our communities – a multi-colored poison specifically designed to attract younger users,” Nassau County District Attorney Anne T. Donnelly said.

And as Halloween nears, officials have been warning families to be especially vigilant regarding their children’s candy before they consume it.

The dangerous drug has been a major driver of fatal and nonfatal overdoses in the US as well as the opioid epidemic.

Although there has been a slight decrease in recent months in drug overdose deaths, the numbers remain high. About 108,000 people died of a drug overdose in the 12-month period ending May 2022 – which is down from the record high of more than 110,000 deaths reported in the 12-month period that ended March 2022, CDC provisional data published Wednesday shows.

The latest overdose death figure remains 32% than it was two years earlier and higher than any other period before November 2021, according to the CDC data. Synthetic opioids, including fentanyl, were involved in more than two-thirds of deaths in the 12-month period ending May 2022, and psychostimulants were involved in nearly a third.

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October 12, 2022
Appeals court can rule at any time in dispute over suspending FDA approval of medication abortion drug | CNN Politics

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CNN
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The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs.

Now that the filings have been submitted, the US 5th Circuit Court of Appeals Court could rule at any time on whether to put a hold on the order from US District Judge Matthew Kacsmaryk.

Kacsmaryk on Friday night said he was halting the FDA’s approval of the drug mifepristone but that he was delaying the order by seven days to give the pill’s defenders time to appeal the case. The Justice Department has asked the appeals court to act by 12 p.m. CT Thursday on its request that Kacsmaryk’s ruling be paused, to give the government time to seek a Supreme Court intervention if need be. The 5th Circuit is not obligated to meet that deadline.

The Justice Department wrote in its new filing that Kacsmaryk purported “to be acting in a restrained manner … but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug.”

“Effectively requiring Danco Laboratories and GenBioPro to cease distribution of mifepristone after more than two decades would upend the status quo, severely harming women, healthcare systems, and the public,” the Justice Department said, referring to the two US manufacturers of mifepristone.

The Justice Department filing pushed back on the assertions by the challengers, made in their filing overnight in the emergency dispute, that the 5th Circuit did not have the authority to hear the appeal of Kacsmaryk’s ruling. The Justice Department also called out Kacsmaryk and the challengers for relying on anonymous blog posts to claim mifepristone is unsafe.

Danco Labroratories, which intervened in the case to defend mifepristone’s approval, wrote in its new filing with the appeals court that if the ruling is not frozen, “women across the nation will face serious, unnecessary health risks from the elimination of access to a drug FDA has repeatedly deemed safe and effective and that is the standard of care.”

In an overnight filing, the anti-abortion doctors who sued to ban medication abortion drugs told a federal appeals court that it should leave in place the ruling that will halt the drug’s FDA approval.

The anti-abortion doctors defended Kacsmaryk’s ruling called it a “meticulously considered” ruling that “paints an alarming picture of decades-long agency lawlessness – all to the detriment of the women and girls FDA is charged to protect.”

Mifepristone has been approved by the FDA for terminating pregnancies for nearly 23 years. Leading medical associations have rebuked the claims by the approval’s legal challengers and by the judge that the drug is unsafe.

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April 12, 2021
Justice Department asks Supreme Court to intervene in abortion drug ruling | CNN Politics

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The Justice Department asked the Supreme Court Friday to intervene in an emergency dispute over a Texas judge’s medication abortion drug ruling, requesting that the court step in now rather than wait for an appeal to formally play out at the federal appellate level.

The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. It centers on the scope of the US Food and Drug Administration’s authority to regulate a drug that is used in the majority of abortions today in states that still allow the procedure.

Solicitor General Elizabeth Prelogar said in the filing that it “concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”

She said that if the ruling were allowed to stand it would “inflict grave harm on women, the medical system, the agency, and the public.”

Danco, a manufacturer of the drug, also asked the justices to step in on an emergency basis before Friday, with an attorney for the company saying in its filing that leaving the lower court opinion in play will “irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under the FDCA nationwide.”

“The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States’ sovereignty interests, and the separation-of-powers,” the attonrey, Jessica L. Ellsworth, told the justices.

The clock is ticking. If the Supreme Court does not step in, the district court’s ruling, as amended by a subsequent appeals court opinion, will go into effect at midnight CT, and access to the drug, Mifepristone, will be restricted while the appeals process plays out.

Both the government and Danco are asking the court to freeze the lower court opinion, or alternatively, agree to take up the case themselves and hear arguments before the summer recess, a very expedited time frame.

The controversy began when US District Court Judge Matthew Kacsmaryk issued a broad ruling that blocks the FDA’s 2000 approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible.

Late Wednesday, the 5th US Circuit Court of Appeals froze part of the ruling. The court said the drug, that was approved in 2000, could stay on the market, but agreed with Kacsmaryk that access could be limited.

The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital to obtain the drug in person.

The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10. It’s possible however that even with the ruling in effect, some providers could go “off-label” and continue to prescribe mifepristone up until 10 weeks. Mifepristone is one of the drugs used for an abortion via medication as opposed to surgery.

Prelogar, the solicitor general, argued in her filing to the Supreme Court that the FDA’s expert judgment should not be challenged.

“FDA has maintained that scientific judgment across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” she wrote, reminding the justices that currently, “more than half of women in this country who choose to terminate their pregnancies rely on mifrepristone to do so.”

She highlighted a key threshold issue in the case, arguing that the doctors opposed to abortion who are behind the suit do not have the legal right to be in court. That is because, she said, they neither “take nor prescribe” the drug, and the FDA’s approval “does not require them to do or refrain from doing anything.”

CNN Supreme Court analyst Steve Vladeck, who is a professor at the University of Texas School of Law, said the 5th Circuit’s ruling “froze the craziest, most harmful parts of Kacsmaryk’s ruling,” but that access to mifepristone is still significantly limited.

“The panel ruled that the challenge to the 2000 approval of mifepristone itself is likely time-barred, so it froze that part of the ruling,” he wrote on Twitter. “But it *didn’t* freeze Kacsmaryk’s block of the 2016 and 2021 revisions that (1) make mifepristone available up to 10 weeks; and (2) by mail.”

Medication abortion has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned the Roe v. Wade precedent that protected abortion rights nationally.

In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA’s 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.

A split 5th Circuit panel said in its order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. But the appeals court said that the abortion pill’s defenders had not shown that they were likely to succeed in defeating the plaintiffs’ claims against the FDA’s more recent regulatory actions toward mifepristone.

The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.

The FDA approved mifepristone after a four-year review process. It has shown to be a safe and effective way to terminate a pregnancy in the two-plus decades it’s been on the market. But anti-abortion doctors and medical associations allege that the agency ran afoul of the law by not adequately taking into account the drug’s supposed risks.

This story has been updated with additional developments.

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April 12, 2021
Three GOP appointees, including 2 from Trump, will hear the next phase of major abortion pill case | CNN Politics

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CNN
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The New Orleans-based appeals court panel that will oversee the next stage in the blockbuster legal challenge to the availability of medication abortion drugs is made up of three Republican appointees, including one Trump nominee who has called abortion a “moral tragedy.”

Circuit Judges James Ho and Cory Wilson, both Trump nominees, will hear the oral arguments on May 17, alongside Judge Jennifer Walker Elrod, an appointee of George W. Bush.

The lawsuit was brought by anti-abortion doctors and medical organizations who allege the US Food and Drug Administration broke the law when it approved the medication abortion drug mifepristone more than two decades ago.

Last month, US District Judge Matthew Kacsmaryk agreed with their arguments and ruled that the approval of the drug should be suspended.

However, his ruling was put on hold by the Supreme Court on April 21 and it will remain on hold until the case goes back to the high court, regardless of how the 5th US Circuit Court of Appeals rules on the merits.

Ho, a former Texas solicitor general, is considered one of the most conservative and strident members of the 5th Circuit, having described abortion as a “moral tragedy” in a 2018 concurring opinion.

In a 2019 concurring opinion, Ho also said that a trial judge’s ruling – which struck down a 15-week abortion ban and which was affirmed by the 5th Circuit under the then-standing Roe precedent – displayed “an alarming disrespect for the millions of Americans who believe that babies deserve legal protection during pregnancy as well as after birth, and that abortion is the immoral, tragic, and violent taking of innocent human life.”

The 5th Circuit is considered one of the most conservative in the country has consistently ruled against the Biden Justice Department.

Wilson earlier this year wrote a majority circuit opinion that said that a federal law that bars gun ownership by people under domestic violence was unconstitutional.

Elrod penned an opinion last month that struck down the federal ban on bump stocks, which are attachments that essentially allow shooters to fire semiautomatic rifles continuously with one pull of the trigger.

The medication abortion case is another hugely consequential case to go through the circuit. Mifepristone – the drug being targeted in the lawsuit – is the first pill in the two-pill regimen for terminating a pregnancy. Medication abortion makes up more than half of all abortions obtained in the United States.

In filings last week, the Justice Department told the 5th Circuit that Kacsmaryk’s conclusions that the drug was unsafe rested “on a series of fundamental errors.”

“While FDA justified its scientific conclusions in multiple detailed reviews, including a medical review spanning more than 100 pages and assessing dozens of studies and other scientific information, the district court swept the agency’s judgments aside by substituting its own lay understanding of purportedly contrary studies, offering demonstrably erroneous characterizations of the record,” the DOJ’s filing said.

The department’s opponents in the case will file a response later on Monday.

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April 12, 2021
Biden administration moves ahead with Medicare drug price negotiations amid industry lawsuits | CNN Politics

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CNN
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Undeterred by a growing number of lawsuits, the Biden administration on Friday released revised guidance for Medicare’s new drug price negotiation program.

The latest guidance outlines how the Centers for Medicare and Medicaid Services will negotiate with drugmakers to reach agreement on a maximum fair price for a selected medicine, the agency said. It was informed by public input on the initial guidance the agency released in March, which explained how it will select the drugs and how the negotiations will be conducted.

The program, which was authorized by the Inflation Reduction Act that congressional Democrats passed last year, has prompted a fierce backlash from the pharmaceutical industry. Two drug manufacturers and two industry groups have filed lawsuits, arguing the measure is unconstitutional.

But the administration is not backing down from implementing its historic new power. It intends to keep its timeline of announcing the first 10 drugs that will be selected for negotiation by September 1. CMS and the drugmakers will negotiate during 2023 and 2024. The prices will be effective starting in 2026.

“The Biden-Harris Administration isn’t letting anything get in our way of delivering lower drug costs for Americans,” Secretary of Health and Human Services Xavier Becerra said in a statement. “Pharmaceutical companies have made record profits for decades. Now they’re lining up to block this Administration’s work to negotiate for better drug prices for our families. We won’t be deterred.”

The initial set of drugs will be chosen from the top 50 Part D drugs that are eligible for negotiation that have the highest total expenditures in Medicare. CMS will consider multiple factors when developing its initial offer, including the drugs’ clinical benefits, the price of alternatives, research and development costs and patent protection, among others.

If drugmakers don’t comply with the process, they will have to pay an excise tax of up to 95% of the medications’ US sales or pull all their drugs from the Medicare and Medicaid markets. The pharmaceutical industry contends that the true penalty can be as high as 1,900% of sales.

CMS said it received more than 7,500 comments on its initial guidance from patient groups, drug companies, pharmacies and others.

The changes it is making are aimed at improving transparency while keeping confidentiality in mind, as well as fostering “an effective negotiation process,” the agency said.

They include revising the confidentiality process to state that CMS will release information about the negotiations when it publishes the explanations of the prices. Also, drug companies may publicly discuss the negotiations – the prior secrecy requirement had been a point of contention among manufacturers that was mentioned in the lawsuits. And they won’t be required to destroy data relating to the negotiations.

In addition, CMS will hold patient-focused listening sessions to provide drug companies and the public more opportunities to engage with the agency. The sessions – which will give patients, caregivers and others the chance to share input on how a medication addresses unmet needs, how it impacts specific populations and what therapeutic alternatives exist – will be held in the fall for the first round of drugs.

Merck, Bristol Myers Squibb, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, and the US Chamber of Commerce have all recently filed lawsuits in federal courts across the US. They each argue the program is unconstitutional in various ways.

The challengers also say that the negotiation provision will harm innovation and patients’ access to new drugs.

Among the arguments are that the program violates the Fifth Amendment’s “takings” clause because it allows Medicare to obtain manufacturers’ patented drugs, which are private property, without paying fair market value under the threat of serious penalties.

Plus, the negotiations process violates the First Amendment, the challengers say, because it coerces manufacturers into saying that they agree to the price that the government has dictated and that it’s fair.

Another argument is that the process violates the Eighth Amendment by levying an excessive fine if drugmakers refuse to negotiate and continue selling their products to the Medicare market.

Merck expects its diabetes drug Januvia to be among the drugs named in September and its blockbuster cancer treatment Keytruda and diabetes drug Janumet to be subject to negotiation in the future. Bristol Myers Squibb believes its blood thinning medication, Eliquis, will be subject to negotiations this year, and its cancer medication, Opdivo, will be selected in a subsequent round.

The changes in the revised guidance did not allay the complaints of the pharmaceutical industry. PhRMA said that transparency remains “severely limited,” patients’ views are not being taken into account and Medicare beneficiaries could have less access to drugs.

“The very few substantive changes to the final guidance demonstrate CMS saw this as a box checking exercise, not an opportunity to mitigate the negative impacts this price setting policy will have on patients or the broader health care sector,” PhRMA said in a statement.

“The approach CMS took in this final guidance confirms what we claimed in our lawsuit – Congress’ unconstitutional shortcuts taken in the law have given the administration far too much flexibility to set prices at their whim without any oversight or accountability to anyone,” the group continued.

The Biden administration will “vigorously defend” the drug price negotiation program, said CMS Administrator Chiquita Brooks-LaSure.

“We feel the law is on our side,” she said in a call with reporters Friday.

This story has been updated with additional information.

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April 12, 2021
Top Treasury sanctions official to visit southern border as it ramps up efforts to crack down on deadly fentanyl trade | CNN Politics

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CNN
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Treasury’s top sanctions official Brian Nelson will travel to the southern border Tuesday as part of the department’s ongoing push to crack down on the cartels and illicit financial networks fueling the deadly fentanyl trade, Treasury officials told CNN.

Nelson’s trip – his second in sixth months – and a spate of recent sanctions activity is the latest indicator that Treasury is ramping up efforts to tackle the illegal fentanyl trade through actions that disrupt the supply chains funneling “precursor” chemicals from China to producers in Mexico where much of the deadly drug is made.

Nelson and Treasury officials will meet with fellow law enforcement representatives, including from the Department of Homeland Security and U.S. Customs and Border Protection, as well as private financial institutions and local officials.

“What we are doing is trying to be as effective as we possibly can in combining Treasury’s tools with the efforts that other US government agencies and allied governments are deploying in this space,” said Nelson, the under secretary for terrorism and financial intelligence at Treasury, in an interview with CNN.

The engagements over the 48-hour trip will provide officials an opportunity to discuss how Treasury’s tools and information can complement law enforcement and to learn about the big issues and patterns that agents are seeing on the ground. The trip is also aimed at exploring how trends and information from the extensive financial information Treasury collects can be helpful to the broader government-wide effort to quell the synthetic opioid epidemic.

Nelson, who will also be joined by the acting director of the Financial Crimes Enforcement Network (FinCEN) Himamauli Das, will visit Laredo and San Antonio in Texas on Tuesday and Wednesday.

In Laredo, Nelson will receive briefings on border operations from CBP officials at the city’s port of entry as well as discuss cargo processing and inspections.

“There’s a credible value in seeing that in person,” Nelson said.

In San Antonio, Nelson and Das will host a “FinCEN Exchange,” which is a public-private information sharing forum where Treasury can share the different patterns and connections they’re seeing with financial institutions, as well as discuss further ways the federal government can partner with the private sector to better spot red flags and identify illicit financial networks.

The department has been involved in the counter-narcotics business for decades, using its tools and financial expertise to both starve criminal organizations of critical financing through sanctions and blocking assets, as well as providing crucial financial data to other law enforcement and federal agencies.

“We can help disrupt financial flows and target the whole supply chain, starting with the precursor chemicals all the way down to distributors bound for US markets. And it’s not just sanctions,” Nelson said, pointing also to FinCEN’s financial mapping tools as well as Treasury’s focus on cooperating with Mexico to improve their capacity to trace and combat illicit finance.

“These tools, combined with financial mapping that our FinCEN team does, is very, very powerful insight,” he added.

Investigators from the Treasury, especially those at FinCEN, can access and share powerful financial data with enforcement bodies like the Drug Enforcement Agency, the Department of Homeland Security and others as they work to track and disrupt the fentanyl trade and drug suppliers.

Nelson also said that Treasury is “absolutely” looking to build on US Secretary of State Antony Blinken’s latest engagements in China, which included discussing where the two nations could cooperate on curbing the flow of precursor chemicals from China. Blinken, who traveled to Beijing last month, said both sides agreed to “explore” establishing a working group on the precursor chemicals used to produce the deadly synthetic drug.

There has been a government-wide push to curb synthetic opioids like fentanyl, which are the main driver of overdose deaths in the US. According to the US Centers for Disease Control and Prevention, there has been a more than seven-fold increase overall in deaths from 2015-2021, and despite a recent slowing, overdose deaths still hover near record levels and remain the third leading cause of death in adolescents aged 19 and younger.

In April, the Biden administration announced a broad effort to target the production and distribution of fentanyl, which included criminal charges from the Department of Justice and a host of new Treasury sanctions.

It was an announcement that built off of an executive order signed in 2021 that expanded Treasury’s authorities to target the distribution chains of fentanyl and other narcotics, which Nelson said has been critical to helping Treasury “increase the pace at which we are able to target and designate the key nodes in fentanyl distribution.”

Since then, Treasury has continued to issue sanctions against precursor chemical supply networks, particularly in China, as well as other corrupt activity like arms trafficking and money laundering that helps support the trade.

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April 12, 2021
There aren’t enough facilities to treat all kids hooked on opioids | CNN Politics

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After writing several previous newsletters on the stunning rise in opioid overdoses in the US, including among adolescents, I thought it was worth taking a look at what happens after an overdose, particularly for adolescents.

I talked to Dr. Sivabalaji Kaliamurthy about what he’s encountering. A child and adolescent addiction psychiatrist who is board certified in general psychiatry, child psychiatry and addiction psychiatry, Kaliamurthy is also the director of the addiction clinic at Children’s National Hospital in Washington, DC.

He told me that his clinic, which he set up in early 2022, has gone from getting one or two opioid use referrals per month to eight or more per month now, a year later.

He particularly wanted to discuss some major news: The opioid overdose antidote naloxone, sold as Narcan, got approval from the US Food and Drug Administration on March 29, the day we talked, to be sold over the counter.

Excerpts from our conversation, edited for flow, are below.

WOLF: What is your reaction to Narcan being available over the counter?

KALIAMURTHY: When I do an evaluation (of a patient), regardless of the substance use, you’re always talking about naloxone, brand name Narcan. …

The message that I present parents with is always that it’s kind of like having a fire extinguisher at home. You hope you never need to use it, but you’re glad that you have it if you need to use it.

Access is important. There are some controversies around increasing access to naloxone and fears that this may encourage more substance use. We have scientific research looking into this very specific question.

And overall, there’s one study that came out this month that found that across 44 states where they increased access to naloxone for adolescents, it did not increase the rates of substance use in this population. And in some states, it actually decreased opioid use among adolescents. …

The FDA approved the over-the-counter sale of naloxone, specifically the brand Narcan, because of how easily it can be administered. Naloxone also comes in other formulations, like injections, but Narcan is a nasal spray. We’re hoping that it will be out later this summer.

The challenge remains how much is it going to cost? On average, it can cost anywhere between $50 to $100 right now. If it becomes over-the-counter, we don’t want insurances to stop covering [it].

It will be interesting to see how the manufacturer goes about introducing it over the counter.

WOLF: You said it’s like a fire extinguisher. Should everybody have it, or just people whose kids have demonstrated addictive behavior?

KALIAMURTHY: Everyone should have it. Naloxone is not a treatment; it is more of an antidote. It reverses opioid overdoses, and the person who has the opioid overdose is never the one who’s going to use it somewhere in the community.

WOLF: I’ve reported on a surge in overdoses. What are you seeing at Children’s?

KALIAMURTHY: We are seeing an increase in the number of kids presenting to the hospital after experiencing an opioid overdose, and in general, opioid overdose deaths in the DMV (Washington, DC, Maryland, Virginia) region have significantly increased in the last two years. That aligns with a national trend we are seeing with regards to opioid overdoses.

WOLF: Is there a profile for who these kids are? Do they share any traits?

KALIAMURTHY: Yes. Let me talk about the kids we do see for opioid-related concerns first.

At Children’s National, children often present after experiencing an overdose or having a medical complication because of using these M30, or the fake Percocet pills. We’ve had kids come in following conditions such as preliminary hemorrhage, where they were bleeding into their lungs, and overdose is not the only concern.

Apart from that, we also have had kids presenting actively using these pills. They haven’t overdosed yet but they’re asking for help to stop using these pills.

Some things that we have noticed, and this is the trend across the DMV region … the kids who are presenting to treatment, these are kids who are motivated to stop – they predominantly identify as Hispanic in ethnicity. Most of them have Medicaid for insurance.

A lot of them, you know, they come to us – the average age is about 16, 16½ and their first use of opioids, these pills, was about a year ago. So the average first use was about 15 to 15½ years of age. They are really struggling, and they want to get better.

KALIAMURTHY: Another common trait: cannabis use is quite common in this population. Pretty much every patient that I’ve come across started off around age 12 using cannabis products. This includes the flower and bud, vapes or edibles. Soon they transition to using the M30 pills.

There are various different reasons, one of which is just access. A lot of other kids are using it. They’re using it in schools. They try it, they like it, and then it escalates and they stop using other substances.

Most of these kids start off with crushing and try it nasally by snorting it and then they transition to smoking. What they do is they put these pills on a piece of aluminum foil, heat it up and inhale the fumes that come up. We haven’t had anyone come in who reported using any of these pills intravenously.

WOLF: How is treatment for adolescents different than treating adult users who are seeking help?

KALIAMURTHY: We have to take into consideration their developmental age and the psychological development that’s happening in adolescence, which is very different from adults.

Oftentimes, this is the first point of entry into opioid use for these kids. Fentanyl, which is one of the most powerful opioids of abuse out there, is the first point of entry into opioid use for these children.

Where for adults, they might have been prescribed pain medications. Or they might have started on opioids through other routes and might have used less potent products before transitioning to fentanyl.

KALIAMURTHY: Historically, adolescents were not always the most motivated to seek treatment for substance use. What we would see was they would start off with experimenting, there would be a problem, it would take a few years and they’re adults by the time they’ve entered treatment and they’re trying different things to treat themselves before they enter treatment.

With adolescents, now we are seeing that they can tell that they need help, and they are motivated and they are entering treatment.

We have to take into account the presence of parents or guardians, how the school system interacts with them, what else do they do in their communities. There’s an increased association of violence and legal trouble that some of these patients end up in that we need to address while treating them. And these are some differences when it comes to treating adolescents versus adults.

WOLF: One local community’s opioid response coordinator stressed to me that lack of availability of treatment is a real problem. Is that something that you agree with?

KALIAMURTHY: Absolutely. That is a real problem at this point, because there is a huge discrepancy between the number of kids who need treatment and the available resources.

The challenge is we can limit access and prevent these kids from getting the pills. But then you have a huge population of kids who are dependent on these pills, who can’t tolerate withdrawal symptoms, who have what we call opioid use disorder. That is going to perpetuate the problem if we’re not treating them. We need to do more in terms of increasing access to care for these kids.

WOLF: Can you illustrate that capacity issue for me, through numbers or data? Or is it more anecdotal?

KALIAMURTHY: Treatment is across different realms.

For example, when a child is using these pills, and they have a problem with substance use, they need to go and be evaluated by a professional who has expertise in both addressing and evaluating mental health and addiction problems. And we don’t have very many people being able to do that.

KALIAMURTHY: The first-time response is usually a counselor or social worker, sometimes physicians.

But generally, there’s very little expertise in the pediatric health space with regards to addressing substance use-related problems. Screening is the point of entry.

KALIAMURTHY: Then, say they need detox beds. Once they’ve entered treatment, we want to help them get through those initial days when their body is kind of adjusting to not using these pills, and we refer to that as detox.

At Children’s National Hospital, when the kids come to the emergency room, we are not able to admit them for detoxes all the time. Sometimes we do end up admitting them.

This depends on the availability of beds. The number of pediatric beds is very small to begin with. And beds may not always be available when somebody presents to the emergency room detox.

And then there’s who is on call? Who’s available to treat these kids? I spoke about the lack of expertise in general, across the pediatric health space, so all that will determine whether a child is able to get access to detox services.

That’s the detox part of treatment, which can be anywhere between two to five days.

Detox doesn’t always mean somebody needs to be admitted. I also do outpatient detox where we are helping kids stop by providing them with medications and guiding their parents or guardians and the child on how to go through detox.

KALIAMURTHY: Once you go through detox, depending on the extent of the problem, a child may require admission to a rehabilitation facility for anywhere between a month to six months.

When we look at the number of facilities in the DMV region that provide this kind of rehab, I don’t think Virginia has any, DC doesn’t have any, Maryland has two. One is Sandstone Treatment Center, which is a private institution. The other is a treatment center, which is closer to Baltimore. There’s a limitation on who they can take.

WOLF: Let me interrupt you. In a region that has millions of people, there are only two facilities that will take adolescents for one to six months’ treatment for substance use?

KALIAMURTHY: Yes. For substance use.

WOLF: Is that just a function of there’s more demand for those kinds of facilities among older people who are more likely to face addiction problems? Is that something the system is pivoting to address right now?

KALIAMURTHY: It’s unclear. The system wants to help, but the challenge is historically adolescents are not always the most eager and motivated to get help.

When we look at treatment programs, that didn’t exist in the past. They often relied on the judicial system, where some of these kids might have been mandated to treatment.

Now we know that substance use disorders are chronic disorders and mandates don’t always work. Courts have stopped mandating treatment, because it’s like you mandate it for a month and then they come out and then what happens? There’s a lot of issues with mandating treatment.

Now, most of the programs that were present prior to the pandemic also shut down during the pandemic because the needs also declined.

This is not financially lucrative. That’s one reason why they’re having a huge issue with finding systems and having the county or the state take over with regards to creating the system.

WOLF: I cut you off there. You were moving from the one-to-six-month facility to the next step in the process.

KALIAMURTHY: So the next step is really engaging these kids in treatment. Not all kids require one to six months. Some kids might be OK with just completing detox and engaging in regular outpatient level of care. This might involve what we call intensive outpatient combined with medication.

Which is where I would come in. A lot of what I do is provide medications for addiction treatment. These medications, the first part is for the detox to help with the child’s symptoms, but once you go through withdrawals, you can still have significant cravings to go back to using.

The challenge, again, is the number of facilities. There are more options for intensive outpatient, but again, they are packed. The wait times to get in are longer now, and some of them are just virtual-only options, which may be good for some kids, but some kids might need more inpatient help.

KALIAMURTHY: After this step, we have regular outpatient therapy and recovery support services, which is also lacking.

The recovery support services are services which help kids get back on track academically. Catch up with your credit, get up on your grades and form a healthy, functioning resume. Get help finding part-time jobs. Keep these kids engaged in activities outside of school so that they are less likely to go back to the path that they were on which led to the substance use.

WOLF: What’s your message to parents who are trying to keep an eye on their kids?

KALIAMURTHY: Let’s look at the national-level data that we have collected up to 2021. Substance use is actually on the decline.

Which is interesting because what is happening is that even though substance use among kids is on the decline – that’s both in middle school and high school – the substances that kids are using have become so much more potent.

Take cannabis, which if you measure the potency by the percentage of THC content, has gone up significantly. The average THC percentage in the ’60s and ‘70s was like 2-5%. And now it’s like 20-25%. And kids are more likely to use what they call the concentrates, which is like 80% or more THC.

When I talk to parents, the first thing I’m telling them about is the landscape of different substances that are out there, and kids are more likely to start off with cannabis or alcohol before they transition to the M30 pills.

KALIAMURTHY: If you think about modifiable and non-modifiable risks, some risks just cannot be changed. These are things like genetics, family history and also if a child has a history of any traumatic experiences. Those are not things you can necessarily change. There are modifiable risk factors, like if a child has ADHD, they’re more likely to be at risk for developing substance use problems.

If there are untreated mental health conditions, such as depression, anxiety, they’re more likely to have problems. We know that. The kids who identify as LGBTQ+, they also tend to have more risk factors in terms of initiating substances that transition into a problem.

But also, we need to rethink how families address substances in the household. Kids learn by modeling they see from adults in their life and also the direct conversations we have. What are their values as a family around use of substances? These are not just legal and illegal – all substance use can have some harm. And early initiation is going to lead to more likelihood of having a problem.

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April 12, 2021
HHS secretary says ‘everything is on the table’ amid calls to ignore medication abortion ruling | CNN Politics

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CNN
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Health and Human Services Secretary Xavier Becerra on Sunday said “everything is on the table” following a Texas federal judge’s ruling to suspend the Food and Drug Administration’s approval of the medication abortion drug mifepristone.

In an interview with CNN’s Dana Bash on “State of the Union,” the secretary would not say whether he believes the FDA should ignore the ruling and keep the drug on the market, but he maintained that the Biden administration is considering all options.

“We want the courts to overturn this reckless decision,” Becerra said, adding that there was a “good chance” of Supreme Court intervention but declining to say how, exactly, the administration will handle the ruling in the interim.

“Everything is on the table. The president said that way back when the Dobbs decision came out. Every option is on the table,” the secretary told Bash, referring to last year’s Supreme Court ruling that overturned Roe v. Wade.

Democratic Rep. Alexandria Ocasio-Cortez, in a separate appearance on “State of the Union,” did not back away from her call Friday on CNN for the ruling to be ignored, saying that if it was ultimately upheld by the Supreme Court, “it would essentially institute a national abortion ban.”

“I do not believe that the courts have the authority over the FDA that they just asserted, and I do believe that it creates a crisis,” she told Bash.

Ocasio-Cortez called the ruling “an extreme abuse of power” and said there was precedent for the executive branch ignoring court rulings.

“I do think that when it comes to gaming out what the very real possibilities are in the coming days, weeks and months, this is not just about speculation, but this is about preparation. And the reality of our courts right now is very disturbing,” she said.

Meanwhile, Republican Rep. Tony Gonzales of Texas warned in a separate interview with Bash on Sunday that House GOP appropriators could defund certain FDA programs if the ruling is ultimately ignored.

“The House Republicans have the power of the purse, and if the administration wants to not lead this ruling, not live up to this ruling, then we’re going to have a problem,” the second-term lawmaker said. “And it may come a point where House Republicans on the appropriation side have to defund FDA programs that don’t make sense.”

US District Judge Matthew Kacsmaryk on Friday issued a ruling to halt the decades-old approval of mifepristone, but he paused the ruling from taking effect for a week so it could be appealed, a process that is underway.

“This is not America,” Becerra said Sunday. “What you saw is that one judge in that one court in that one state, that’s not America. America goes by the evidence. America does what’s fair. America does what is transparent, and we can show that what we do is for the right reasons. That’s not America.”

Within an hour of the ruling Friday, a different federal judge ruled in favor of 17 Democratic-led states and Washington, DC, looking to expand access to the abortion pill, allowing them to keep the drug available.

Becerra on Sunday touted the proven safety of the drug, a factor that Kacsmaryk questioned in his ruling. He confirmed that the Department of Justice had already filed its appeal and is waiting for its day in court.

Still, Becerra had little to say about what tangible preparations the administration would take to secure access to abortion should the drug no longer be available after the weeklong pause.

“Well, [women] certainly have access today, and we intend to do everything to make sure it’s available for them not just in a week but moving forward, period,” Becerra told Bash when asked if women would have access to the medication after this week.

The Justice Department and Danco, a mifepristone manufacturer that intervened in the case to defend the approval, have both filed notices of appeal. 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 remains frozen while the appeal moves forward.

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

“I got to believe that, Dana, an appeals court, the Supreme Court, whatever court has to understand that this ruling by this one judge overturns not just access to mifepristone, but possibly any number of drugs,” Becerra said.

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April 12, 2021
YourEncore® Joins AARP® Employer Pledge Program

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National effort helps employers solve staffing challenges, directs job seekers to employers that value and hire experience

Press Release
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updated: Jun 12, 2017

Indianapolis, IN, June 12, 2017 (Newswire.com)
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YourEncore, a leading provider of world-class expertise for flexible resourcing and consulting engagements to life sciences and consumer goods companies, has joined more than 450 organizations in signing the AARP Employer Pledge, confirming their commitment to hiring across the age spectrum and leveraging the value that experienced workers bring to companies of all sizes.

“YourEncore was founded on the core principle that experience matters,” said Mike Lewis, Chief Sales & Marketing Officer at YourEncore. “Our mission is to put experience to work. We offer clients the opportunity to tap into the most accomplished and experienced community of experts in the world, and we offer our talent community, or YourEncore Experts as we call them, the opportunity to use their experience to make a lasting difference. We are excited to join with AARP in its mission to drive awareness of the wisdom, experience, and technical skill of accomplished business professionals.”

“YourEncore was founded on the core principle that experience matters. We are excited to join with AARP in its mission to drive awareness of the wisdom, experience, and technical skill of accomplished business professionals. We’re passionate about creating the workforce of the future…one that is ageless, inspires and engages talent, and accelerates business performance. We look forward to working with AARP on this all-important journey.”

Mike Lewis, YourEncore Chief Sales & Marketing Officer

Employers are facing a chasm of wisdom, experience, and absolute talent supply that places achievement of their business objectives at risk. Over 10,000 Baby Boomers retire every day. While Millennials currently provide the workforce with a large infusion of talent, their numbers alone are still not enough to stem the tide of departing Boomers¹. This talent gap cannot be closed with traditional employment models. Given the seismic shifts taking place in today’s workforce, companies need to think differently about how they utilize talent, and individuals need to think differently about how they approach work. YourEncore is uniquely positioned to provide both groups with the solutions they need to successfully navigate and take advantage of this perfect storm that is today’s economy.

YourEncore combines cutting-edge technology and high-touch personal engagement to build robust, vibrant talent communities, match talent to business requirements, and create tailored talent solutions that allow clients to transform and grow and Experts to realize their personal and professional goals.

Although some Boomers are stepping away from traditional full-time, career-focused employment, many want to continue working, for a host of reasons from social to professional to financial². YourEncore is a leader in mobilizing this “encore workforce” and has helped thousands of Experts build successful consulting careers through rewarding project work and professional development.

For clients, YourEncore deploys world class expertise from their Expert Network to solve complex problems, support critical initiatives, and fill capability and capacity gaps. Experts are hand-picked and matched for subject matter expertise and business acumen. They are alumni from some of the best companies in the world, average over 25 years of experience, and the majority hold advanced degrees. The power of that experience – which the AARP Employer Pledge Program is designed to elevate – is the impetus behind the founding and on-going growth of YourEncore.

“We’re passionate about creating the workforce of the future…one that is ageless, inspires and engages talent, and accelerates business performance,” said Lewis. “We look forward to working with AARP on this all-important journey.”

About YourEncore®: YourEncore is a leading provider of proven expertise, delivering flexible resourcing and consulting services to the biopharma, medical devices and diagnostics, and consumer goods industries. YourEncore mobilizes the wisdom and knowledge of highly experienced, immediately effective Experts to help companies outthink, outpace, and outperform. Based in Indianapolis, IN, with offices in Cincinnati, OH and Princeton, NJ, YourEncore was named a “100 Most Brilliant Company” by Entrepreneur Magazine. For more information, visit yourencore.com and follow us on Facebook @YourEncore, Twitter @YourEncoreInc, and LinkedIn.

¹https://www.conference-board.org/laborshortages/

²https://www.transamericacenter.org/docs/default-source/retirement-survey-of-workers/tcrs2016_sr_perspectives_on_retirement_baby_boomers_genx_millennials.pdf

Media Contacts:

Mike Lewis 609.216.7903 mike.lewis@yourencore.com

Nancy Reilly 513.609.4516 nancy.reilly@yourencore.com

Source: YourEncore, Inc.

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June 12, 2017