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Tag: Birth control

  • Why Can’t I Stop Reading Birth Stories?

    Why Can’t I Stop Reading Birth Stories?

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    I’m obsessed with birth stories, but for so common an act, they’re hard to come by, which is telling in and of itself. For the last decade, I’ve asked people about their pregnancies, childbirths, and transitions to motherhood. The first birth story I heard was from a friend who was too afraid to learn anything about birth. She complied with her doctor’s orders during labor, but she tore badly while pushing, which she couldn’t feel because she was anesthetized. I hurt for her, and her experience haunted me. But I was certain that it was unique to her. I couldn’t have been more wrong.

    The details variegate, but the takeaway is very often the same: birth didn’t go as planned; it went haywire. Healthy people with normal pregnancies become patients with risks, diagnoses, near-death experiences, damage. They assume—or are told after the fact—that something was wrong with their body or their baby.

    Was the fact that I was hearing too many bad birth stories to count somehow a product of the people who gave birth? After all, in many cases, they reported to me that it was somehow their own fault.

    Or did the blame lie elsewhere? At the feet of an overburdened hospital systems pushing profits or the patriarchal and white supremacist structures that created and govern them? To what extent did women and birthers believed these forces shaped their births and pregnancies.

    We accept the mantra that birth is unpredictable and that we’re lucky, blessed, to leave with our lives intact and babies pulsing in our arms.”

    In our society, we buy expecting mothers baby gifts. We notice, comment on, and touch their changing bodies. We mostly ignore and fail to support their shifting selves. Baby arrives, and she’s all we see. As if a literal stork dropped her off. The journey of the soul and body that gave birth aren’t discussed. Most often, they’re erased. Pregnancy turns our bodies into a new kind of public commodity and a receptacle for others’ ideas about who we are.

    Women enter pregnancy brimming with all they have learned from books, films, the internet, and experts. We bring into the labor ward the stories we’ve heard, coveted, or wished away. My greatest fear was surgical birth or tearing. I expended so much energy during my first pregnancy praying to avoid those things. Many of us experience birth as disappointment, manipulation, and (whether or not we use this word) abuse. Sometimes we feel this as it’s happening; other times it goes unchecked, and we may need years to see it, if we ever do. We quietly blame a doctor who withheld support, a grouchy nurse, a problem with our body or baby that we internalize. Then we chastise ourselves for not having predicted or fixed it. We excuse bad judgments, unnecessary medicine we are “consented to,” horrendous bedside manner, or lies that masquerade as care. And we are gaslit into believing all of this is lifesaving—for our baby, for ourselves.

    We slough off that birth attendants refused to do what we asked or failed to ask us before doing things to our bodies. We turn the blame inward when elements of our births don’t go to plan. If only we hadn’t hoped for that natural birth so hard. Stupid to enter an orchard wishing for magic fruit. Or perhaps we should have learned more about C-sections in birth class—we could have avoided surgery or prepared for it. We vow not to plan so hard next time, not to get our hopes up, lest we be disappointed and feel blamed again. We accept the mantra that birth is unpredictable and that we’re lucky, blessed, to leave with our lives intact and babies pulsing in our arms.

    Art Nahpro/Paul Jackson

    We don’t live in birth long enough to see it for what it really is. Birth is a system built in tandem with a profession founded on fear of the generative power of the birthing body. Obstetrics is a specialty constructed with the belief that Black pregnant bodies tolerate more pain and are predisposed to disease, while white pregnant bodies’ frailty requires expert control—medical arts, tools, drugs. The profession is highly skilled while simultaneously hamstrung by hospital systems for which maternity services turn the heftiest profit. Every birth is a manufactured healthcare crisis only doctors with rigid protocols in multi-million-dollar hospital systems can solve. It is a system that has evolved to control women for money.

    Hospitals are where about 98 percent of American childbirth occurs. We go to them for many reasons—among them, culture and convention, the law, and ignorance. We flee the safety and security of our homes and the people we love and trust most and yield our bodies to facilities that exist to stave off death and treat disease. We easily accept the idea that they are safe places to birth because their function is preservation.

    But we are in female bodies, Black bodies, trans bodies, and our protection is not guaranteed. In the hospital, our well-being and sometimes our lives are needlessly put at risk. A bevy of technologies, policies, drugs, practitioners, and administrators control us. They tell us that we’re too fast, too slow, too early, too late, too loud, too quiet, too much, not enough. These are familiar criticisms because, as women and birthing people, we hear them throughout our lives in other contexts. We come to know these condemnations like lovers. They first enter our thoughts and self-talk; then they worm into us, becoming not external modifiers but facts.

    Birth Control: The Insidious Power of Men Over Motherhood

    Birth Control: The Insidious Power of Men Over Motherhood

    Birth Control: The Insidious Power of Men Over Motherhood

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    The truth is that no matter how much we learn about birth before having a baby, control is wrested from us with a sinister precision when birth day comes. We are told explicitly and implicitly that we are not experts in our own bodies, that strangers know best, that to be kept safe amid a tsunami of danger, we must submit to nameless faces who command with degrees, acronyms, mandatory procedures, protocols, monitoring, and an endless parade of fears. Physiological birth becomes not about nature, selfhood, or exaltation but about survival. And if you survive, well, even brutal means justify the end.

    Reproduction and birth are about power—who has it and who doesn’t. The people doing the procreating don’t. Birth must return to our control. Our lives depend on it.

    From Birth Control: The Insidious Power of Men Over Motherhood by Allison Yarrow. Copyright © 2023 by Allison Yarrow. Published by Seal Press. All rights reserved.

    Headshot of Allison Yarrow

    Allison Yarrow is an award-winning journalist, speaker, and author of 90s Bitch, a finalist for the Los Angeles Press Club book award. She was a National Magazine Award Finalist, a TED resident, a producer at NBC News and Vice, a reporter and editor at Newsweek and The Daily Beast, and her writing and commentary have appeared in many publications.

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  • FDA Approves First Over-The-Counter Birth Control Pill

    FDA Approves First Over-The-Counter Birth Control Pill

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    The FDA has approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception. What do you think?

    “It will be a nice six months until the Supreme Court bans this.”

    Helena Rogers, Control Center Specialist

    “I’m proud to be alive for such a watershed moment in the history of fucking.”

    Damien Rodriguez, Shortcut Designer

    “Did they recommend an accompanying prison term?”

    Emil Benton, Unemployed

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  • Birth Control Isn’t the Only Thing That Just Went Over-the-Counter

    Birth Control Isn’t the Only Thing That Just Went Over-the-Counter

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    The FDA announced yesterday that it had for the first time approved a daily birth-control pill for over-the-counter sales. That’s a big change; once the product, called Opill, is on the market—which may be as soon as early 2024—Americans will be able to buy daily hormonal birth control without a prescription. That’s historic news, but hidden underneath it is another set of firsts: In the coming months, Americans will also be able to grab an over-the-counter treatment for their heavy periods, cramps, headaches, and even migraines; they’ll have prescription-free access to a drug for endometriosis and polycystic ovary syndrome; and they’ll be able to buy a medication that can mitigate the symptoms of menopause. It’s all in the same, progestin-based pill.

    The FDA’s approval only covers Opill’s use as a form of birth control, but doctors have been prescribing pills that contain progestin for noncontraceptive needs for years. For the most part, the intervention works much better when the pills include both progestin and estrogen. Adding that second hormone to the mix amplifies all of progestin’s beneficial effects, plus helps control hormonal acne. It also leaves more wiggle room in terms of timing: Progestin-only pills—sometimes called a minipill—have a much shorter half-life in the body, so if you don’t take them during the same three-hour window each day, they’re much less reliable at preventing pregnancy, says Anne-Marie Amies Oelschlager, the chief of pediatric and adolescent gynecology at Seattle Children’s. (Some women are prescribed progestin-only pills because they are particularly susceptible to certain risks associated with estrogen.)

    As a result, an over-the-counter progestin-only pill is far from the best way of treating these conditions, experts told me. “While I suppose that it could be used off-label, I would be hesitant to do that if someone was otherwise able to obtain a prescription for a combined oral contraceptive,” Erin Fleurant, a family-planning fellow at Northwestern Medicine, told me. And if progestin by itself really were the right approach, then an IUD, implant, or injection might be a more effective way to deliver the drug.

    Despite the fact that progestin on its own would not usually be a doctor’s first choice—“I generally don’t prescribe it,” Veronica Ades, the vice chair of ob/gyn at Jacobi Medical Center, told me—the drug can have meaningful benefits when taken on its own. Amies Oelschlager told me that she prescribes it to suppress patients’ periods, especially if they’re experiencing pain or heavy bleeding. Even low-dose pills (like Opill) can be helpful for controlling period- and perimenopause-related migraines, as well as mood swings from premenstrual syndrome or premenstrual dysphoric disorder.

    Progestin pills can also be used to treat endometrial hyperplasia, an abnormal thickening of the uterine lining (a.k.a. the endometrium) that can develop into cancer. Same for endometriosis, a condition that may affect up to 11 percent of American women in which endometrial tissue grows outside the uterus. Patients with PCOS produce unusually high levels of male sex hormones and, Ades said, generally have too much estrogen in their body relative to progesterone (the naturally occurring analogue of progestin). Progestin pills can help strike a healthier balance.

    Right now, patients have few options to get relief from any of those symptoms without a doctor’s help. Until Opill hits the market, the best non-prescription way to treat PCOS is with healthy eating and exercise, Amies Oelschlager told me. For heavy periods, the best option patients can buy without a prescription is an NSAID like ibuprofen. “As far as an over-the-counter, daily hormonal medication, this is the first in the United States,” she said.

    Perhaps the best circumstances for off-label use of Opill will be as a stopgap. If someone starts having abnormal bleeding or period pain but can’t get an appointment or travel to a doctor for several weeks, they could buy themselves some progestin-only pills for the interim. Opill could also be a backup plan for patients who are already taking birth-control pills for a non-birth-control purpose but can’t make it to their doctor to renew their prescription, or can’t get their prescription filled at a pharmacy.

    Still, Ades cautioned that even stopgap use might not be wise for endometriosis patients, for whom switching medications could disrupt a delicate balance of hormones and “create a cascade of problems.” Fleurant warned that some of the symptoms that progestin pills could help alleviate may also be associated with very serious conditions that need a different treatment plan. “Say someone was 45 years old and having irregular bleeding and also had a lot of other risk factors for uterine cancer. I wouldn’t want them to pick up this pill and think that that was going to cure everything,” she said. Instead, they should be seen by a health-care provider.

    For most women who need to be on birth control, a single-hormone drug like Opill is not the most reliable option; but starting next year, it could well be the most convenient. That same trade-off, between effectiveness and access, affects other uses of progestin, too.

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    Rachel Gutman-Wei

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  • 7/13: CBS Evening News

    7/13: CBS Evening News

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    7/13: CBS Evening News – CBS News


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    FDA approves first over-the-counter birth control; FTC launches investigation into ChatGPT

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  • FDA approves first over-the-counter birth control

    FDA approves first over-the-counter birth control

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    FDA approves first over-the-counter birth control – CBS News


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    The Food and Drug Administration on Thursday approved Opill as the first ever birth control pill that can be sold without a prescription. Opill has been available in the U.S. by prescription for about 50 years. Janet Shamlian has more.

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  • FDA approves first over-the-counter birth control pill, Opill

    FDA approves first over-the-counter birth control pill, Opill

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    The U.S. Food and Drug Administration has approved the first over-the-counter birth control pill, allowing Americans to buy a daily oral contraceptive without a prescription.

    Opill, the progestin-only pill from drugmaker Perrigo, will provide an option for obtaining oral contraceptives without needing to first see a health care provider, in hopes of reducing barriers to access, according to the FDA’s news release, which notes that almost half of the 6.1 million pregnancies in the U.S. each year are unintended.

    “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release Thursday morning. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

    In a press briefing following the FDA’s decision, Frederique Welgryn, Perrigo’s global vice president of women’s health, called the approval “a historic moment and a revolutionary change in contraceptive access and reproductive health.”

    How does Opill work? 

    Opill is made up of norgestrel, a kind of “progestin-only” birth control pill that was first approved as safe and effective to be prescribed by doctors in the 1970s. This is different from other birth control pills that are largely prescribed today, which are newer “combined” formulations that also use estrogen.

    Hormone-based pills, which have all required a prescription until now, have long been the most common form of birth control in the U.S., the Associated Press reports. Tens of millions of women have used them since the first pills came on the market in the 1960s. 

    Is Opill safe?

    The FDA says Opill is “safe and effective” when used properly. The guidelines include taking the pill at the same time every day; not using it along with another hormonal birth control product, including IUDs (intra-uterine devices); and avoiding medications that interact with it, which could decrease its efficacy.

    “Opill should not be used by those who have or have ever had breast cancer,” the FDA’s release adds. “Consumers who have any other form of cancer should ask a doctor before use.”

    According to the FDA, the most common side effects of Opill include: 

    • Irregular bleeding
    • Headaches
    • Dizziness
    • Nausea
    • Increased appetite
    • Abdominal pain
    • Cramps or bloating

    When will Opill be available? 

    The company is expected to start shipping the pill early next year, the AP reported, and there will be no age restrictions on sales.

    The FDA says the drug will be available in drug stores, convenience stores and grocery stores, as well as online.

    How much will Opill cost?

    Welgryn did not provide over-the-counter pricing information in Thursday’s briefing, but said it was Perigo’s mission to make it “affordable and accessible to people who need it.”

    While over-the-counter medicines are generally cheaper than prescription drugs, they aren’t typically covered by insurance.

    Welgryn said the company is hoping to change that approach by insurers, but did not have an estimated timeline for coverage, noting that it will “take time.”

    Alex Tin and the Associated Press contributed to this report.

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  • FDA Approves First Over-the-Counter Birth Control Pill

    FDA Approves First Over-the-Counter Birth Control Pill

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    This is a developing story. Stayed tune for reaction to today’s FDA decision. 


    July 13, 2023 – The FDA today approved the first birth control pill for women that does not require a prescription. The product, OPill, is expected to be available early next year. 


    The over the counter OPill is the same norgestrel birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy or other retail location without having to see a doctor first. 


    The manufacturer Perrigo Company based in Ireland has not yet announced how much the pill will cost. The price tag could have implications for how widely available this form of birth control becomes. It can be as much as 93% effective in preventing pregnancy. Perrigo says it plans to make the pill available at low or no cost to some women.


    The approval follows a

    unanimous vote

    among 17 experts on an FDA advisory committee on May 10. The panel recommended the product be made available over the counter, stating it offers more potential benefit than harm. 



    WebMD Health News


    Sources

    SOURCE: 


    FDA: “FDA Approves First Nonprescription Daily Oral Contraceptive.”

     



    © 2023 WebMD, LLC. All rights reserved.

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  • First over-the-counter birth control pill gets FDA approval

    First over-the-counter birth control pill gets FDA approval

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    WASHINGTON — U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.

    The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.

    Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

    Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

    Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.

    “This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”

    Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren’t covered by insurance.

    Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which women’s advocates are urging the Biden administration to implement.

    Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa.

    Perrigo submitted years of research to FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.

    FDA’s action only applies to Opill. It’s in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.

    But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.

    That said, FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone. The studies in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe v. Wade, which has upended abortion access across the U.S.

    With some states curtailing women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to ease access to birth control. The American Medical Association and the leading professional society for obstetricians and gynecologists backed Opill’s application for over-the-counter status.

    An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May where dozens of public speakers called for Opill’s approval.

    Dyvia Huitron was among those who presented, explaining how she has been unable to get prescription birth control more than three years after becoming sexually active. The 19-year-old University of Alabama student said she still isn’t comfortable getting a prescription because the school’s health system reports medical exams and medications to parents.

    “My parents did not let me go on the pill,” Huitron said in a recent interview. “There was just a lot of cultural stigma around being sexually active before you’re married.”

    While she uses other forms of contraception, “I would have much preferred to have birth control and use these additional methods to ensure that I was being as safe as possible.”

    Huitron spoke on behalf of Advocates for Youth, one of the dozens of groups that have pushed to make prescription contraceptives more accessible.

    The groups helped fund some of the studies submitted for Opill and they encouraged HRA Pharma, later acquired by Perrigo, to file its application with the FDA.

    Advocates were particularly interested in Opill because it raised fewer safety concerns. The pill was first approved in the U.S. five decades ago but hasn’t been marketed here since 2005.

    “It’s been around a long time and we have a large amount of data supporting that this pill is safe and effective for over-the-counter use,” said Blanchard, of Ibsis Reproductive Health.

    Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries a heightened risk of blood clots and they shouldn’t be used by women at risk for heart problems, such as those who smoke and are over 35.

    Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective.

    In its internal review published in May, the FDA noted that some women in Perrigo’s study had trouble understanding the drug’s labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem.

    Common side effects of the pill include bleeding, headaches, dizziness, nausea and cramps, according to the FDA. The label also cautions that certain drugs can interfere with Opill’s effectiveness, including medications for seizures, HIV and hypertension.

    Perrigo executives said the company will spend the rest of the year manufacturing the pill and its packaging so it can be available in stores early next year.

    ___

    Follow Matthew Perrone on Twitter: @AP_FDAwriter

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • Arizona governor makes contraceptive medications available over the counter at pharmacies

    Arizona governor makes contraceptive medications available over the counter at pharmacies

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    Adults in Arizona can now obtain contraceptive medications over the counter at a pharmacy without a doctor’s prescription under a governor’s order announced Thursday

    FILE – Democratic Arizona Gov. Katie Hobbs delivers her State of the State address at the Arizona Capitol in Phoenix, Jan. 9, 2023. Adults in Arizona can now obtain contraceptive medications over the counter at a pharmacy without a doctor’s prescription under a governor’s order announced Thursday, July 6, 2023. (AP Photo/Ross D. Franklin, File)

    The Associated Press

    PHOENIX — Adults in Arizona can now obtain contraceptive medications over the counter at a pharmacy without a doctor’s prescription under a governor’s order announced Thursday.

    Gov. Katie Hobbs said the rule will go into effect immediately. It applies to self-administered birth control such as hormonal and oral contraceptives, and patients 18 or older need only complete a screening and a blood pressure test.

    “We are building an Arizona for everyone, which means ensuring people across the state have what they need to live a free and healthy life,” the Democratic governor said in a statement.

    Over 20 states have statutes that let pharmacists dispense FDA-approved hormonal contraceptives without a prescription, according to a statement from the Arizona Department of Health Services.

    Hobbs has used her executive powers in recent weeks to promote reproductive freedom. In June she issued a sweeping executive order effectively stripping prosecutors of their ability to pursue charges against anyone involved with a legally obtained abortion.

    She also plans to support legislation next year that would codify access to birth control.

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  • Morning-after pill vending machines gain popularity on college campuses post-Roe

    Morning-after pill vending machines gain popularity on college campuses post-Roe

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    SEATTLE — Need Plan B? Tap your credit card and enter B6.

    Since last November, a library at the University of Washington has featured a different kind of vending machine, one that’s become more popular on campuses around the country since the U.S. Supreme Court ended constitutional protections for abortion last year. It’s stocked with ibuprofen, pregnancy tests and the morning-after pill.

    With some states enacting abortion bans and others enshrining protections and expanding access to birth control, the machines are part of a push on college campuses to ensure emergency contraceptives are cheap, discreet and widely available.

    There are now 39 universities in 17 states with emergency contraceptive vending machines, and at least 20 more considering them, according to the American Society for Emergency Contraception. Some, such as the University of Tulsa in Oklahoma, are in states where abortion is largely banned.

    Over-the-counter purchase of Plan B and generic forms is legal in all 50 states.

    The 2022 ruling overturning Roe v. Wade “is putting people’s lives at stake, so it makes pregnancy prevention all the more urgent,” said Kelly Cleland, the ASEC’s executive director. “If you live in a state where you cannot get an abortion and you can’t get an abortion anywhere near you, the stakes are so much higher than they’ve ever been before.”

    Washington this year became first U.S. state to set aside money — $200,000 to fund $10,000 grants that colleges can obtain next year through an application process — to expand access to emergency contraceptives at public universities and technical colleges through the automatic dispensers.

    The University of Washington’s machine was installed after a student-led campaign. It offers boxes of generic Plan B for $12.60, about a quarter of what the name-brand versions sell for in stores, and more than 640 have been sold.

    The drug is even cheaper in some machines than it is in UW’s, as low as $7 per box. That’s because it is sold at just above wholesale cost, compared with pharmacy retail prices that might go up to $50.

    In Illinois and New York, lawmakers are developing legislation that would require at least one vending machine selling emergency contraceptives on state college campuses.

    In Connecticut, Yale had to drop plans to install an emergency contraceptive vending machine in 2019 after learning it would violate state law.

    But this year the state approved a measure allowing Plan B and other over-the-counter medications to be sold from vending machines on campuses and other locations.

    The machines can’t be placed in K-12 schools or exposed to the elements, and they must have temperature and humidity controls and include plans for power outages and expired items.

    “This just enables people to have better access and easier access,” said Rep. Nicole Klarides-Ditria, one of several Republicans in Connecticut’s Democratic-controlled General Assembly who supported the measure. “You may need Plan B, as we all know, in the middle of the night, and you won’t have access to a pharmacy until the morning.”

    Although the morning-after pill has been approved by the Food and Drug Administration for over-the-counter sale, many stores and pharmacies keep it behind the counter or locked up, require identification for purchase and make the experience of purchasing it intimidating.

    “There is a stigma associated with getting access to these medications,” said Zoe Amaris, a University of Washington pharmacy student and board member of UW Pharmacists for Reproductive Education and Sexual Health. “Having a vending machine is so easy. You don’t need to go to a pharmacy. You don’t need to go through your health care provider.”

    Plan B is more effective the sooner it is taken, and vending machine access could be particularly crucial for victims of rape when pharmacies are closed. The anonymity the machines afford may also be important to some assault victims.

    “When you have a vending machine, it takes away a lot of those barriers,” Cleland said. “Students can go on their own terms to get it when they need it.”

    ___

    Haigh reported from Hartford, Connecticut.

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  • Can President Biden’s executive order help American women get better birth control?

    Can President Biden’s executive order help American women get better birth control?

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    It can still be incredibly difficult for U.S. women to get access to the right birth control—but last week, President Biden issued an executive order that could finally make a difference.

    Biden issued the wide-ranging order, which includes several directives to protect and expand access to contraception, almost exactly one year after the Supreme Court overturned the constitutional right to an abortion. As part of his mandates, the president instructed federal agencies to address widespread insurance-industry practices that prevent women from accessing their preferred birth control. The order was issued two months after Fortune published an investigation into those problems.

    Private insurance companies regularly refuse to fully cover some contraceptives, despite being required to do so by the Affordable Care Act, Fortune’s April investigation found. As a result, many women are unable to afford the birth control they want (and their medical providers prescribe), while the companies that develop and sell new kinds of contraceptives have struggled to stay in business.

    On Friday, Biden specifically ordered federal agencies to address these problems, by considering issuing “new guidance” to ensure that private insurers fully cover women’s contraception. Such guidance could also “streamline the process for obtaining care women need and want,” the White House said. (White House advisers also acknowledged “some of the reports out there about [insurers’] failure to comply” with the Affordable Care Act, Stat News reported on Friday.)

    These pervasive insurance coverage problems have contributed to a worsening reproductive health crisis: Almost half of all U.S. pregnancies are unplanned, according to the Guttmacher Institute. Now that the Supreme Court has overturned Roe v. Wade, millions of women with such unintended pregnancies no longer have access to abortions and adequate reproductive health care.

    Biden’s executive order did not discuss a specific deadline for federal agencies to take new action. But reproductive-health advocates and industry executives alike celebrated the White House’s action, calling it a promising step in the right direction.

    “I’m really hopeful,” Mara Gandal-Powers, director of birth control access and senior counsel for the National Women’s Law Center, tells Fortune. “It certainly indicates that this is really high priority for the President—and I do think that the agencies listen when these kinds of things come out.”

    Executives at Agile Therapeutics, which makes a new kind of contraceptive patch called Twirla, also said they were heartened by the president’s order. They hope the federal agencies will release new guidance as soon as this summer, in what they call a best-case scenario—or, in a worst-case scenario, sometime next year.

    Agile spent more than a decade, and invested about $250 million, to get regulatory approval for Twirla—at a time when many larger and better-funded pharmaceutical companies have stopped investing in women’s health. But after the company launched its product in 2020, it discovered that insurance providers would routinely reject doctors’ prescriptions for it. In 2022, insurers refused to fully cover 55% of the prescriptions doctors wrote for Twirla, according to Agile—which lost more than $25 million last year.

    In the past few months, Agile has raised money and continued to increase sales, but it’s still fighting insurers to get its product covered. (The company reported a net loss of $5.4 million for the first quarter of 2023.) Now CEO Al Altomari is hoping that the White House’s intervention will help him get back to his core business of selling birth control, without all the expensive insurance wrangling.

    “My company’s fighting for its life right now. A couple of us are,” Altomari says. “I wanted it last year—but this could be really good.”

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  • Biden will sign an order seeking to protect birth control access a year after Roe was overturned

    Biden will sign an order seeking to protect birth control access a year after Roe was overturned

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    WASHINGTON — President Joe Biden is banking on reproductive rights to be a galvanizing issue for voters in the 2024 election as he collects three top-level endorsements, hosts a rally and issues an executive order seeking to bolster access to contraception as the nation marks a year since the Supreme Court decision overturning federal abortion protections.

    Biden and Vice President Kamala Harris on Friday are being endorsed by Planned Parenthood Action Fund, NARAL Pro-Choice America and Emily’s List. The groups are throwing their early support behind the reelection effort in part to highlight the importance of the issue for Democrats heading into the election year, the groups’ leaders told The Associated Press.

    “I think that President Biden has been an incredibly valuable partner, along with Vice President Harris, in fighting back against the onslaught of attacks that we have seen,” said Alexis McGill Johnson, president and chief executive of Planned Parenthood Action Fund. “We are heading into an election where opposition is very clear — they are pushing for a national ban. And we have an administration that has taken actual steps to protect patients and providers during this health care crisis. The choice is really clear.”

    Biden and fellow Democrats have already seen the power of the issue: A majority of Americans want legalized abortion nationwide. In the leadup to the 2022 midterm elections, many political pundits dismissed the issue, but it was among the top concerns for voters, who consistently rejected efforts to restrict abortion in the states when given the chance.

    Biden’s campaign manager, Julie Chavez Rodriguez, said the president and the vice president were proud to have earned the support of the groups. Since the decision last year by the Supreme Court, “we have seen the horrifying impact that the extreme MAGA agenda has on women’s health,” she said, referring to former President Donald Trump’s “Make America Great Again” slogan.

    “MAGA Republicans promising a national abortion ban makes the stakes for reelecting President Biden and Vice President Harris all the more important,” she said in a statement. She added that the organizing power of the three groups was essential to Democrats’ strong performance in the 2022 midterms and will be again.

    Biden has said he’ll work to protect reproductive health care, including enshrining abortion rights in federal law. He’s expected to convey that message in remarks Friday at a rally with first lady Jill Biden, Harris and second gentleman Doug Emhoff.

    Meanwhile, just a mile (1.6 kilometers) from where Biden will be speaking, the Faith & Freedom Coalition is holding its annual conference, at which GOP presidential candidates will be urged to keep pushing for stronger abortion restrictions and work to allay fears that the push will backfire with voters. Trump, the GOP primary front-runner, will speak there on Saturday, even as he has suggested that strict abortion restrictions are a weakness for Republicans.

    Ralph Reed, founder and chairman of the Faith & Freedom Coalition, said “we’re certainly going to do everything that we can, as an organization and as a pro-life and pro-family movement, to give our candidates a little bit of a testosterone booster shot and explain to them that they should not be on the defensive. Those who are afraid of it need to, candidly, grow a backbone.”

    Biden’s executive order aims to strengthen access to contraception, a growing concern for Democrats after some conservatives have signaled a willingness to push beyond abortion into regulation of contraception. In 2017, nearly 65% or 46.9 million of the 72.2 million girls and women age 15 to 49 in the U.S. used a form of contraception.

    “We’re really trying to do three separate things all related to each other,” said Jen Klein, a top Biden aide on gender policy. “The first is increased and expanded contraceptive options. The second is to lower out-of-pocket costs. And the third is to raise awareness about what options are available.”

    The leading voices on abortion rights were always going to endorse the Democratic president for reelection. But the heads of the three organizations say getting out early and loudly behind Biden and Harris is important on an issue that will animate voters, despite talk that it’s no longer top of mind.

    “The longer these bans are in place, the more people either will know someone who has experienced something or read a terrible story,” said Mini Timmaraju, head of NARAL Pro-Choice America. “They have to make a decision about where to go to college based on the states with the bans. They have to make a decision about whether to practice medicine based on an abortion ban. It’s permeating everyday life now, and it’s having unintended consequences.”

    The consequences of restricting abortion access are quickly moving beyond ending an unwanted pregnancy into miscarriage and pregnancy care in general. Women in states with tight restrictions are increasingly unable to access care for pregnancy-related complications. Doctors facing criminal charges if they provide abortions are increasingly afraid to care for patients who aren’t sick enough yet to be considered treatable.

    Since the Supreme Court overturned the landmark 1973 decision in Roe v. Wade, which legalized abortion, 22 states have passed either a ban or highly restrictive policies on abortion. Other states, though, have expanded access to abortion care. The Biden administration has brought together leaders from all 50 states to talk strategy on how to expand access and work together to help people in more restrictive states.

    “We should recognize that even in conservative states, there has been considerable friction to restricting rights. And that friction is born of independent women, voters and people who are not super engaged in the political process, really coming out because of this issue,” said Neera Tanden, Biden’s top domestic policy aide. “There are places where anti-choice forces have expected an easy passage of laws restricting women’s rights and they have experienced a lot more turmoil — sometimes even from Republican women legislators.”

    Most of the states with severe abortion restrictions are also states that have a high maternal mortality rate and higher rates of stillbirth and miscarriage. Black women are disproportionately affected — they are more than three times more likely to die from pregnancy-related causes than white women, according to the U.S. Centers for Disease Control and Prevention.

    Harris has argued it’s not a coincidence, given that maternal health care and abortion care are linked. The same medical procedures used to perform an abortion are the ones used to treat miscarriage.

    For Emily’s List, an advocacy group for Democratic female candidates, Harris, the first female vice president, is a powerful symbol, president Laphonza Butler said.

    “She is the highest-serving woman who has broken the hard glass ceiling of representing women in the White House,” Butler said. “This is the administration using every bully pulpit it can to advance reproductive health and freedom across the country. ”

    ___

    Follow the AP’s coverage of abortion at https://apnews.com/hub/abortion.

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  • FDA panel recommends sale of birth control pill without prescription

    FDA panel recommends sale of birth control pill without prescription

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    FDA panel recommends sale of birth control pill without prescription – CBS News


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    A Food and Drug Administration advisory panel on Wednesday recommended that the birth control pill Opill be sold over the counter without a prescription. Opill, a progestin-only pill, was first approved for use by the FDA in the 1970s. Meg Oliver has more on what comes next in the process.

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  • FDA panel backs over-the-counter sales of birth control pill

    FDA panel backs over-the-counter sales of birth control pill

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    WASHINGTON — Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication.

    The panel of FDA advisers voted unanimously in favor of drugmaker Perrigo’s request to sell its once-a-day medication over the counter. The recommendation came at the close of a two-day meeting focused on whether women could safely and effectively take the pill without professional supervision. A final FDA decision is expected this summer.

    If the agency follows the nonbinding recommendation, Perrigo’s drug, Opill, would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves. The company said sales could begin late this year if OK’d.

    The outside experts said they were mostly confident that women of all ages could use the drug appropriately without seeing a health provider first.

    “In the balance between benefit and risk, we’d have a hard time justifying not taking this action,” said Maria Coyle, an Ohio State University pharmacist, who chaired the panel. “The drug is incredibly effective, and I think it will be effective in the over-the-counter realm just as it is in the prescription realm.”

    The positive vote came despite numerous criticisms from FDA scientists about how Perrigo studied the drug, including questions about whether study participants were able to understand and follow labeling instructions.

    “We have an application with many complicated issues and uncertainties, including questionable reliability,” FDA’s Dr. Pamela Horn told panelists on Tuesday.

    But the panel largely set those concerns aside, emphasizing the benefits of providing more effective birth control, particularly to young people and lower-income groups, than what’s available over the counter now, like condoms and diaphragms.

    Most birth control pills used in the U.S. today contain a combination of progestin and estrogen. Opill is part of an older class of contraceptives that only contain progestin. They generally have fewer side effects and health risks but can be less effective if they’re not taken around the same time daily.

    FDA’s decision won’t apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other drugmakers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa.

    Nonprescription medicines are usually cheaper, but generally not covered by insurance. Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government.

    Opill was first approved in the U.S. five decades ago based on data showing it was more than 90% effective in preventing pregnancy when taken daily. But some women should not take it, particularly those with breast cancer, because of the risk that it could accelerate tumor growth. Women who have unusual vaginal bleeding are instructed to speak with a doctor before using it, because bleeding could indicate a serious health issue.

    But in reading comprehension studies conducted by Perrigo, 68% of women with unexplained bleeding incorrectly answered they could take the drug. And a few women with breast cancer also told researchers they could use Opill.

    Panel members said almost all women with a history of breast cancer would be under the care of a cancer specialist, who would advise them not to take hormonal drugs that could make their condition worse.

    “I would think any woman who had a breast cancer diagnosis in the past would be highly aware of that, so I don’t think that’s going to be a concern,” said Dr. Deborah Armstrong of Johns Hopkins University.

    Perrigo said its 880-patient study of the drug showed that women will consistently take the pill daily if it’s made available over-the-counter. But the FDA found several problems in the study, including more than 30% of participants who erroneously reported taking more pills than they were actually supplied. FDA reviewers said the problem called into question the company’s overall conclusions about the drug’s use and effectiveness.

    FDA regulators also suggested changes in U.S. demographics since the pill was first tested — including increased obesity and other chronic conditions— could reduce the drug’s effectiveness.

    Despite those concerns, Opill has the support of dozens of reproductive rights and medical groups that have long pushed for expanded access to birth control.

    “Opill over the counter would give us one more option for access and the more options that are available the better,” said Clare Coleman, president of the National Family Planning and Reproductive Health Association

    Coleman was one of more than 25 speakers who supported Perrigo’s application during a public comment session Tuesday.

    Catholic groups, including the United States Conference of Catholic Bishops, oppose the move, saying women should be evaluated by a doctor before getting it.

    Even if the pill is approved, it’s unclear how popular it might be. Opill has not been marketed in the U.S. since 2005 and was previously owned by Pfizer. Perrigo acquired the drug with its buyout of French drugmaker HRA Pharma last year.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • Chelsea Handler Delivers Topless PSA Urging Men To Get Vasectomies

    Chelsea Handler Delivers Topless PSA Urging Men To Get Vasectomies

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    Chelsea Handler has a major message for men about birth control — and she delivered it totally bare-chested.

    In a new Instagram reel captioned “Men, it’s time to do your part,” the comedian dished out a stern yet hilarious PSA urging men to consider getting vasectomies as a practical way to prevent unwanted pregnancies.

    Handler — who referred to herself as “Chesty Handlerberg” in a video posted Sunday that’s since garnered over 3 million views — had much to say about how women are disproportionately responsible for birth control.

    “Since the beginning of time, women have been ducking and diving and dodging pregnancy face-first — or Pikachu-first — and, frankly, they’re exhausted,” she said while simultaneously giving herself a breast exam in bed.

    “We’ve had to listen to men say things like, ‘Girl, but using a condom doesn’t feel so good,’ or ’Can’t you just take birth control?” Or “Oops, I forgot to pull out.” Enough, you little horny little pigs in blankets,” she added.

    The Netflix star — who also endorsed the “Free The Nipple” campaign empowering women to go topless in public — described the physical pain and negative hormonal effects contraceptives such as IUDs can cause women.

    “Women are tired of making concessions for men, especially in the bedroom,” Handler added. “We have already been through enough, letting you wear socks while you penetrate us. So man up, men. And if you can’t do that, enjoy the company of your hand.”

    The former late-night talk show host then wrapped up her unorthodox PSA with a final message: “Vasectomies. One snip and that’s it!”

    A vasectomy, a quick medical sterilization procedure for men to prevent future pregnancies, is safe and highly effective, according to the National Institutes of Health.

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  • Over-the-counter birth control pill faces FDA questions

    Over-the-counter birth control pill faces FDA questions

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    WASHINGTON — U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.

    But in an initial review posted Friday, the Food and Drug Administration raised numerous concerns about drugmaker Perrigo’s application to sell its decades-old pill over the counter.

    The FDA cited problems with the reliability of some of the company’s data on the drug, Opill, and questioned whether women with certain other medical conditions would correctly opt out of taking it. The agency also noted signs that study participants had trouble understanding the labeling instructions.

    Advisers to the FDA meet next week to review drugmaker Perrigo’s application. The two-day public meeting is one of the last steps before a final FDA decision.

    If the agency grants the company’s request, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.

    Friday’s FDA review suggests regulators have serious reservations about broad access to the drug, including whether younger teenagers will be able to correctly follow the labeling directions.

    At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. The panel vote is not binding and the FDA is expected to make its final decision this summer.

    Perrigo executives say Opill could be an important new option for the estimated 15 million U.S. women — or one-fifth of those who are child-bearing age — who currently use no birth control or less effective methods, such as condoms.

    “We have no doubt that our data clearly shows that women of all ages can safely use Opill in the over-the-counter setting,” Frederique Welgryn, the company’s global vice president for women’s health, said this week.

    The company’s application has no relation to the ongoing lawsuits over the abortion pill mifepristone, which is not a contraceptive. Research for over-the-counter sales of the pill began nearly a decade ago.

    Hormone-based pills, like Opill, have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s.

    Opill was first approved in the U.S. 50 years ago. Perrigo acquired rights to the drug last year with its buyout of Paris-based HRA Pharma, which bought the pill from Pfizer in 2014. It’s not currently marketed in the U.S. but is sold without a prescription in the U.K.

    FDA’s decision won’t apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other pill makers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa.

    Many common medications have made the over-the-counter switch, including drugs for pain relief, heartburn and allergies. Generally, drugmakers must show that consumers can accurately understand and follow the labeling instructions to safely and effectively use the drug. Non-prescription medicines are usually cheaper, but generally not covered by insurance. Forcing insurers to cover over-the-counter birth control would require a regulatory change by the Department of Health and Human Services.

    Perrigo’s main study tracked nearly 900 U.S. women taking its pill without professional supervision for up to six months. The group included women of different ages, races, educational and cultural backgrounds.

    Women were paid to track and record their use of the pill, including whether they followed instructions to take it during the same 3-hour window each day. That consistency is key to the drug’s ability to block pregnancy.

    But after Perrigo wrapped up its study, the FDA identified a problem: nearly 30% of women erroneously reported taking more pills than they were actually supplied.

    The FDA said Friday these cases of “improbable dosing” call into question the company’s results.

    Perrigo will present a reanalysis of the data that excludes the participants who overreported. The company says the results showed the study still achieved its goal of demonstrating that most women used the pill correctly.

    Women reported taking the pill on a daily basis 92% of the time during the study, the company says.

    The company says its data show there would be about two pregnancies for every 100 women who take its pill for a year. But the FDA called this figure “an imprecise estimate” because the study was significantly smaller than those typically used to evaluate contraceptive effectiveness.

    The most popular birth control pills today contain a combination of synthetic hormone progestin, which helps block pregnancy, plus estrogen. The addition of estrogen can help make periods lighter and more regular but it also carries the risk of rare blood clots.

    Opill contains only progestin, making it a safer option and, according to experts, an easier regulatory switch to over-the-counter status. But progestin-only pills have downsides, including reduced effectiveness if they’re not taken at the same time daily.

    The FDA review also flagged concerns that women with potential health problems will appropriately avoid taking the drug.

    Women with a history of breast cancer should not take the pill, though a few participants in preliminary research incorrectly said they thought they could. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem. But the FDA notes that half of women in Perrigo’s study who had unexplained bleeding incorrectly said Opill would be appropriate for them.

    Several major U.S. medical groups, including the American Medical Association, support making the drugs available over the counter. The 60-year history of birth control pills shows “the benefits of widespread, nonprescription availability far outweigh the limited risk,” the group stated in comments submitted to the FDA.

    Catholic groups, including the United States Conference of Catholic Bishops, are opposing Opill’s application, saying women should be evaluated by a doctor before getting it.

    ___

    Follow Matthew Perrone on Twitter: @AP_FDAwriter

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • FDA considering first over-the-counter birth control pill

    FDA considering first over-the-counter birth control pill

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    A team of Food and Drug Administration staff revealed Friday that they have a number of reservations over a drugmaker’s request to become the first in the U.S. to sell birth control pills without a doctor’s prescription. The company, HRA Pharma, is seeking permission for over-the-counter sales of norgestrel tablets, a kind of daily birth control that would be marketed as Opill.

    Among the concerns is that some people might not be able to correctly figure out whether it would be safe and effective for them to take the drug. And a key study submitted to the agency included “improbable” results that the FDA worries may “call into question the reliability of all of the actual use data” from it.

    The federal review team’s unease, detailed in a 130-page document published by the FDA, comes ahead of a joint meeting scheduled for two agency panels next week to weigh the request. 

    Birth Control Pill
    This illustration provided by Perrigo in May, 2023, depicts proposed packaging for the company’s birth control medication Opill.

    Perrigo via AP


    After presentations Tuesday from a range of experts, as well as the FDA and HRA Pharma, the agency plans to ask the two advisory groups — the Nonprescription Drugs Advisory Committee and Obstetrics, Reproductive and Urologic Drugs Advisory Committee — to discuss and vote around their concerns.

    While the FDA is not legally required to approve drugs based on their advisory committee votes, the agency says the meetings play a key role in advising staff wrestling with tricky questions posed by drug company submissions.

    Study issues

    Draft discussion questions for the meeting suggest the FDA could ask HRA Pharma to try and repeat its “actual use study” simulating consumers actually taking the drug home and using it, as if it was an over-the-counter birth control product.

    The first of these studies run by the company ran aground early, the FDA says, “due to technical failures in the daily use of the electronic diary” and other issues with data collection. 

    Results from a second attempt were ultimately submitted to the agency, dubbed Adherence with Continuous-Dose Oral Contraceptive Evaluation of Self-Selection and Actual Use or ACCESS. 

    But the FDA says it found some participants in ACCESS reporting taking more tablets than they were actually given, potentially undermining the reliability of the entire study.

    There are also concerns that too many Americans may not follow the directions for safe and effective use. That worry is further complicated by scarce data on adolescents using the drug.

    As one risk, some participants with current or previous breast cancer — who should not take norgestrel because it can stimulate tumor growth — “failed to correctly deselect” from taking the pills in both the ACCESS study and a separate targeted study.

    Norgestrel’s efficacy was also called into question. Since it was first approved in 1973 under the brand name Ovrette, norgestrel has since been superseded in the American market by newer birth control options.

    Unlike combined oral contraceptives, norgestrel “relies more stringently on taking the tablet at approximately the same time each day.” Recent approvals have revealed that contraceptives may also be less effective in overweight or obese people, the FDA said.

    “Given that this product was approved in the 1970s and the paucity of data in today’s target population of reproductive females in the United States, real-world effectiveness of this product in the United States remains ill-defined,” the reviewers wrote.

    Expanding access

    The FDA team acknowledged that direct consumer access to birth control pills could substantially reduce barriers that Americans face in getting contraception, bypassing the need for doctor’s appointments to get prescriptions. 

    It could also cut down on Americans shelling out for less effective “nonhormonal, use-as-needed contraceptive choices” that are currently available in over-the-counter in stores, they said.

    “Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” Dr. David Aizuss said in a statement released by the American Medical Association last year, urging the FDA to expand access to birth control pills without age restrictions.

    HRA Pharma, in a press release by its parent Perrigo, had touted its submission to the FDA last year as “a groundbreaking moment in contraceptive access and reproductive equity in the U.S.”

    The committee had initially been scheduled to meet last November to discuss the product, branded as Opill by HRA Pharma. 

    But the company disclosed last year that the FDA had postponed the meeting, as well as pushing back its target to decide on approval by three months.

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  • A Vaccine for Birth Control?

    A Vaccine for Birth Control?

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    For half a century, Gursaran Pran Talwar has been developing what he hopes will be the next big thing in birth control. A nonagenarian who was once the director of India’s National Institute of Immunology, Talwar envisions bringing to market a new form of contraception that could block pregnancy without the usual trade-offs—an intervention that’s long-acting but reversible; cheap, discreet, and easy to administer; less invasive than an intrauterine device and more convenient than a daily pill. It would skip messy, sometimes dangerous side effects, such as weight gain, mood swings, and rare but risky blood clots and strokes. It would embody the sort of “set it and forget it” model that’s become a gold standard for health—and, in his words, be “accepted by the world over.”

    Talwar’s invention is now in early-stage clinical trials. If all goes well, it could become humanity’s first contraceptive vaccine—one that would prevent pregnancies in a way distinct from any birth control ever cleared for human use. Whether they’re packaged as pills, patches, implants, or shots, most common medical contraceptives work by flooding the body with hormones to put a pause on ovulation. Talwar’s vaccine would do something different: It leaves the menstrual cycle unaltered, instead leveraging the powers of the immune system to keep unwanted pregnancies at bay.

    But temporarily vaccinating against pregnancy is both brilliant in concept and devilishly difficult in execution, both scientifically and socially. Making a contraceptive vaccine effectively means “trying to immunize an animal against itself,” says Julie Levy, a feline-infectious-disease expert at the University of Florida who has worked on immunocontraceptives in animals. Which runs counter to the prime directive of immune systems, evolved over countless millennia to distinguish the foreign from the familiar and to leave the body’s most vital tissues alone. Solve that problem, and researchers will still be left with another: persuading people to take a fertility-hampering shot in an era of widespread vaccine hesitancy—while the specter of contraception’s problematic past still looms.

    For many decades, the most stubborn barriers in contraception have been not about science, but about access and acceptance. Talwar remembers those issues crystallizing sharply for him in the 1970s, he told me, when he encountered several groups of women in the holy city of Varanasi, who told him they were struggling to feed their large families.  Yet the women’s husbands weren’t eager to use condoms and they themselves weren’t satisfied with the pills and IUDs available at the time, which sometimes interfered with normal menstruation and ovulation, and triggered headaches and mood swings. “I wanted to make something free of all these problems,” Talwar told me.

    Within a few years, he had cooked up a solution: a vaccine against hCG, a hormone exclusive to pregnancy that’s necessary for fertilized eggs to implant. Taught to neutralize hCG, Talwar reasoned, the immune system could stop a pregnancy from ever truly starting, without attacking other tissues. His hunch so far appears to have panned out. By the mid-1990s, his team had shown in small, early-stage clinical trials that most women receiving the shots could produce enough antibodies to prevent pregnancy for several months, in some cases more than a year. Of the 119 women in the trial whose antibody levels reached what Talwar deems a protective threshold, only one became pregnant over a period of almost two years. Several participants also went on to conceive after opting out of boosters, a sign that the shot’s effects were reversible.

    Almost immediately, though, drawbacks appeared. Immune responses are infamously variable across individuals—a major reason that the effectiveness of many shots designed against pathogens tops out around 60 to 80 percent. About a fifth of the women who received the hCG vaccine didn’t produce enough antibodies to meet the protective threshold. Those stats would still be enough to slow the transmission of, say, a deadly respiratory virus. But the expectations for a contraceptive “have to be different,” says Neel Shah, the chief medical officer of Maven Clinic, a virtual clinic for women’s and family health. The top IUDs on the market prevent more than 99 percent of pregnancies, require one appointment to insert, and last for up to a decade.

    For now, the hCG vaccine is more cumbersome than that. In its current iteration—a revamp of the successful ’90s recipe—it requires an initial series of at least three doses, spaced out over several weeks. It’s still unclear how people would figure out when, and how often, to boost without regular antibody tests. The answer will likely differ from person to person; that uncertainty alone could make these shots a tough sell, says Diana Blithe, a contraception expert at the National Institutes of Health. And although halting hormonal contraceptives can reset fertility back to baseline within days or weeks, some people with especially enthusiastic immune responses could end up waiting far longer for the hCG vaccine’s effects to wear off, says Aaron Hsueh, a reproductive biologist at Stanford. For that reason and more, Hsueh has said for years that he’s “not enthusiastic” about Talwar’s experimental shot.

    There is some reason to think these issues aren’t insurmountable. Immunocontraceptives have been used for decades by wildlife scientists to prevent pregnancies in all sorts of mammals—among them deer, horses, elephants, pigs, and seals—as a more humane alternative to culling. And in that context, at least, researchers have found a way to circumvent the need for frequent boosts. Certain animals can be dosed with nanoparticles that slowly release the vaccine’s ingredients over months and years, repeatedly tickling the immune system without any additional jabs, says Derek Rosenfield, a veterinarian and wildlife biologist at the University of São Paulo. Work in wild creatures, though, has also shown how hard it is to persuade the body to target its own hormones. To get their shots to work, veterinarians have needed to include powerful adjuvants, or vaccine ingredients meant to rile up the immune system—“some of the most potent ones ever developed,” Levy told me. Which exacts a tax for the shots’ potency: In some animals, such as cats, the vaccines can cause worrying side effects, including injection-site reactions.

    In humans, where safety standards must be stricter and effectiveness better, Talwar’s hCG vaccine has encountered some issues with tolerability, too. The shots so far do seem to be skirting the side effects of pills and IUDs. But some of the women in his team’s ongoing trials are developing painless but prominent nodules—a likely sign that the new recipe’s adjuvants are riling up the immune system a tad too much. To deliver on a discreet, low-maintenance contraceptive—something with, as Talwar puts it, “zero side effects”—they’ll need to tinker with dosing or ingredients.

    Gaps in the contraceptive market do need to be filled. Technology has come a long way since Talwar first spoke with the women in Varanasi, but “we need more options,” says Debanjana Choudhuri, the director of programs and partnerships at India’s Foundation for Reproductive Health Services. Nearly half the world’s pregnancies are unplanned, and access to existing contraception is inconsistent, inequitable, and still stymied by stigma and misinformation; even in places where availability isn’t an issue, some people hesitate over the trade-offs. A temporary contraception, packaged into a super-safe vaccine, could offer convenience and privacy, with potential appeal for young urbanites, who have already been enthusiastic about injectable contraceptives and might not mind getting boosts, Choudhuri told me. Most important, adding a vaccine to the repertoire gives people “another choice.”

    But for all its unique perks, a contraceptive vaccine could also come with social drawbacks. The history of contraception is riddled with abuses, often concentrated among poor populations, people struggling with mental-health issues, and communities of color. Vaccines’ primary purpose for centuries has been to fight infectious disease, and “pregnancy is not a disease,” Sanghamitra Singh, the policy-and-programs lead at the Population Foundation of India, told me. Implying—even unintentionally—that the condition is a problem to be eradicated could stigmatize the shot.

    Deploying the vaccine primarily in under-resourced populations could also raise the specter of the eradication of fertility in society’s most vulnerable subsects. Lisa Campo-Engelstein, a reproductive bioethicist at the University of Texas Medical Branch, worries that even the vaccine’s ease of administration—an ostensible benefit—could be viewed as a downside: Administering a shot without a patient’s full understanding or consent is easier than coercively inserting an IUD or forcing a daily pill. And in this pandemic era, a contraceptive vaccine will likely be met with pushback from people already disinclined toward shots—especially amid false accusations that other immunizations compromise fertility. On top of all that, a shot that goes after hCG can prevent only implantation, not fertilization, a guaranteed sticking point for people who believe that life begins at conception, and may argue that the vaccine triggers abortion.

    In part, the timing is just bad luck. Shortly after his original clinical trial results were published, in the ’90s, Talwar, already late into his 60s, was asked to retire from the National Institute of Immunology, he told me, and had to leave his vaccine behind. After he managed to revive his efforts with the help of independent funders, Indian regulators took nearly a decade to green-light a new recipe for clinical trials—just in time for the coronavirus pandemic to begin. Régine Sitruk-Ware, a reproductive endocrinologist at the Population Council’s Center for Biomedical Research, in New York, remembers the initial buzz around the human hCG vaccine when Talwar’s clinical-trial results were published. But in the absence of more progress, she and other researchers have moved on, she told me. Many now have their sights set on long-acting reversible male birth control, several new forms of which are now close to being publicly available, and could offer safe complements to female methods and make family planning more equitable.

    Still, Talwar, who will turn 97 in October, hasn’t lost hope; to him, the nodules represent one of the last major hurdles, and should be resolved soon. As his 100th birthday ticks closer, he’s even thinking of how he can expand his approach—repurposing the hCG shot, for instance, into immunotherapy against certain cancers that aberrantly produce the hormone. “I am healthy and hearty,” he told me. “I just hope and pray,” he said, that his invention might clear its final hurdles “before I call it a day.”

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    Katherine J. Wu

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  • Is Your Birth Control as Safe as You Think?

    Is Your Birth Control as Safe as You Think?

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    SOURCES:

    Colleen Krejewski, MD, assistant professor of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh.

    Sheila Chhutani, MD, OB-GYN, Texas Health Presbyterian Hospital Dallas.

    Richard Kaye, MD, OB-GYN, Texas Health Presbyterian Hospital Plano.

    American Congress of Obstetricians and Gynecologists, Committee Opinion: “Risk of Venous Thromboembolism Among Users of Drospirenone-Containing Oral Contraceptive Pills.”

    Centers for Disease Control: Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use.

    FamilyDoctor.org: Progestin-Only Contraceptives.

    National Cancer Institute: Oral Contraception and Cancer Risk.

    Marchbanks, PA, Contraception, April 2012.

    Bedsider.org: “What’s the Risk?”

    FDA.gov: Depo-Provera Contraceptive injection (medroxyprogesterone acetate) injectable suspension

    Berenson, A, American Journal of Obstetrics & Gynecology, March, 2009

    American Congress of Obstetricians and Gynecologists, Committee Opinion: “Depot Medroxyprogesterone Acetate and Bone Effects”

    Planned Parenthood: “IUD,” “When does an IUD start working?”

    Association of Reproductive Health Professionals: “Health Matters Fact Sheets: Copper T IUD,” “Non-hormonal Contraceptive Methods,” “Methods Match.”

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  • The implications of Walgreens’ decision on abortion pills

    The implications of Walgreens’ decision on abortion pills

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    Walgreens says it will not start selling an abortion pill in 20 states that had warned of legal consequences if it did so.

    The drugstore chain’s announcement Thursday signals that access to mifepristone may not expand as broadly as federal regulators intended in January, when they finalized a rule change allowing more pharmacies to provide the pill.

    Here’s a closer look at the issue.

    ABOUT THE ABORTION PILL

    The U.S. Food and Drug Administration approved mifepristone in 2000 to end pregnancy, when used in combination with a second drug, misoprostol. The combination is approved for use up to the 10th week of pregnancy.

    Mifepristone is taken first to dilate the cervix and block a hormone needed to sustain a pregnancy. Misoprostol is taken a day or two later, causing contractions to empty the uterus.

    More than half of U.S. abortions are now done with pills rather than with a procedure, according to the Guttmacher Institute, a research group that supports abortion rights. In rare cases, the drug combination can cause excess bleeding, requiring emergency care.

    WIDENING ACCESS

    For more than 20 years, the FDA limited dispensing of mifepristone to a subset of specialty offices and clinics due to safety concerns.

    The agency has repeatedly eased restrictions and expanded access, increasing demand even as state laws make the pills harder to get for many women.

    In late 2021, the agency eliminated an in-person requirement for getting the pill, saying a new scientific review showed no increase in safety complications if the drug is taken at home. That change also permitted the pill to be prescribed via telehealth and shipped by mail-order pharmacies.

    Earlier this year, the FDA further loosened restrictions by allowing pharmacies like Walgreens to start dispensing the drug after they undergo certification. That includes meeting standards for shipping, tracking and confidentially storing prescribing information.

    STATES STEP IN

    Typically, the FDA’s authority to regulate prescription drug access has gone unchallenged. But more than a dozen states now have laws restricting abortion broadly — and the pills specifically — following last year’s Supreme Court decision overturning the federal right to abortion.

    Last month, attorneys general in 20 conservative-led states warned CVS and Walgreens in a letter that they could face legal consequences if they sell abortion pills by mail in their states.

    In addition to state laws, attorneys general from conservative states have argued that shipments of mifepristone run afoul of a 19th century law that prohibited sending items used in abortion through the mail.

    WALGREENS’ REACTION

    A spokesman says the company told the attorneys general that it will not dispense mifepristone in their states and it doesn’t plan to ship the drug to them as well.

    But Walgreens is working to become eligible through the FDA’s certification process. It plans to dispense the pills where it can legally do so.

    The company is not currently dispensing the pills anywhere.

    OTHER DRUGSTORES

    Rite Aid Corp. said it was “monitoring the latest federal, state, legal and regulatory developments” and would keep evaluating its policies. The Associated Press also sought comment from CVS Health Corp., retail giant Walmart and the grocery chain Kroger.

    Some independent pharmacists would like to become certified to dispense the pills, said Andrea Pivarunas, a spokeswoman for the National Community Pharmacists Association. She added that this would be a “personal business decision,” based partly on state laws. The association has no specifics on how many will do it.

    OTHER LEGAL ISSUES

    In November, an anti-abortion group filed a federal lawsuit in Texas seeking to revoke mifepristone’s approval, claiming the FDA approved the drug 23 years ago without adequate evidence of safety.

    A federal judge could rule soon. If he sides with abortion opponents, mifepristone could potentially be removed from the U.S. market.

    In January, abortion rights supporters filed separate lawsuits challenging abortion pill restrictions imposed in North Carolina and West Virginia.

    Legal experts foresee years of court battles over access to the pills.

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    AP Health Writer Matthew Perrone contributed to this story.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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