FDA considers selling over-the-counter birth control pills

WASHINGTON — More than 60 years after the birth control pill was approved that revolutionized women’s sexual health, the Food and Drug Administration received its first prescription for the pill. over-the-counter – just like the Supreme Court’s decision to overturn Roe v. Wade. puts more equitable access to contraception at the heart of the conflict over reproductive rights.

A Paris-based company, HRA Pharma, announced on Monday that it has asked the FDA to allow its prescription pills, sold by prescription, to be sold over-the-counter in the United States. Cadence Health, another pill maker that has been in close dialogue with the FDA about moving its tablets to over-the-counter status, said it hopes to get closer to filing an application next year.

Frédérique Welgryn, the company’s director of strategy and innovation, said the timing of HRA Pharma’s FDA filing, just weeks after the Supreme Court’s decision, was “a truly sad coincidence”. “Birth control is not a solution to access to abortion,” she said.

Under normal circumstances, an application for over-the-counter drug sales may go unnoticed in Washington. But birth control is a delicate matter for FDA Cadence, and HRA Pharma has bogged down for many years during the agency’s pre-application process, and the HRA’s formal application comes at a particularly difficult time in the reproductive rights campaign.

The Supreme Court ruling in Dobbs against the Jackson Women’s Health Foundation, which removed Roe and removed the constitutional right to abortion, included a agree with the opinion by Justice Clarence Thomas suggests that the 1965 decision establishing the right to contraception should also be overturned. On Friday, President Biden condemned Dobbs’ ruling as “a crude exercise of political power” and vowed to expand access to reproductive health care.

On Capitol Hill, scores of House Democrats signed a Letters this year to Robert Califf, FDA commissioner, asking for a “timely review” of any application for over-the-counter birth control pills. More than 100 Democrats have signed a bill that would require insurance companies to cover the cost of over-the-counter birth control. (The Affordable Care Act required insurance companies to cover prescription contraceptives.)

“As we are witnessing the failure and chaos of the Supreme Court decision, many families are looking, ‘Well, how can I make sure I control the choices? own life?’” Senator Patty Murray, a Democrat of Washington, said. Chairman of the Senate Health Committee and lead sponsor of the measure. “We want to make sure that not only women have access, but also those who have difficulty in this regard have access.”

HRA Pharma officials said they expect an FDA decision in about 10 months, which is typical for over-the-counter applications. The FDA declined to comment.

Reproductive rights advocates are also calling on Mr. Biden to ask the FDA to expedite a review of over-the-counter contraceptives at Dobbs’ decision. Dana Singiser, founder of the Contraceptive Access Initiative, a nonprofit advocacy group, said experience with Covid-19 shows that the FDA “can do emergency work during a public health emergency.” copper, that’s what women are facing right now with Roe v. Wade. “

But Mr. Biden has taken a stance against the FDA, Jen Klein, who advises the president on gender policy, told reporters on Friday that the agency “must do its process”. And if history is any guide, the road to approval will be bumpy.

In 2011, the FDA approved the over-the-counter sale of Plan B, an emergency contraceptive pill, to teenagers 16 years of age and younger — only to Kathleen Sebelius, then secretary of health in the Obama administration. , take. extremely rare step passed its decision after President Barack Obama expressed reservations about giving the drug to minors without parental consent. Sebelius was eventually approved by a federal judge.

“Years of legal wrangling finally led them to follow the science,” said Kelly Blanchard, president of Ibis Replictive Health, a global nonprofit group. cooperation with HRA Pharma to carry out the necessary research to submit an application. “We expect them to follow the science and approve without age restrictions in this case.”

But youth access may emerge as a pivotal point. The leaders of the anti-abortion movement don’t take a stand on over-the-counter birth control pills, but they vehemently oppose giving the pills to minors without adult involvement.

“I agree with Obama; Kristi Hamrick, a spokeswoman for the anti-abortion group, said the pills should not be sold recklessly. “As a father of two daughters, he understands that getting adults out of the equation is a problem.”

About half of all pregnancies in the United States are unintended, according to the Guttmacher Institute, a research organization advocating abortion rights. Reproductive rights activists see the OTC pill as an easy and effective tool for people in rural, poor and historically marginalized communities to avoid unwanted pregnancy, thereby reducing the abortion rate.

Dobbs’ decision caught the attention of barriers Women, especially the poor, face access to contraceptives – a point that Rep. Barbara Lee of California and Diana DeGette of Colorado, Democrat chaired the caucus of choice. of the House, stated in a letter they sent to Dr. Califf in March. .

“Despite decades of proven safety and efficacy, people still face enormous barriers to birth control due to systemic inequalities in the care system. our health,” the letter was also signed by 57 other Democrats. “These barriers are disproportionately borne by people of color, immigrants, LGBTQ+ people, low-income people, youth and people in rural communities.”

In a May 18 reply, Dr. Califf wrote that the FDA “recognizes the public health benefits of increased access to oral contraceptives”. The decision on whether to approve over-the-counter birth control, he said, is “guided by the best science available.”

Young people are eager for over-the-counter pills, says Angela Maske, manager of #FreeThePill Youth Council, an advocacy group.

Maske, 25, said she was denied contraception as a student at Georgetown University, a Catholic institution whose student health center provides contraception if needed for certain situations. medical conditions, such as acne, “but not directly for contraception,” according to its website.

The policy, she said, made her feel as though she was being encouraged to lie, which “felt disgusting and immoral”. She says the over-the-counter drug – which she notes is available in more than 100 countries – will solve the problem.

Medical experts say the birth control pill is one of the safest and most researched drugs on the market, but getting the necessary prescription can be a barrier to access. Several major medical organizations, including American Medical Associationthe American College of Obstetricians and Gynecologists and American Academy of Family Physiciansstates that birth control pills are suitable for over-the-counter use.

HRA Pharma’s oral tablet is called a mini-pill, which means it contains only the hormone progestin, which plays a role in the menstrual cycle and pregnancy.

The mini-pill is widely used in the UK, but accounts for less than 10% of the market for oral contraceptives in the US, in part because the pill can cause irregular bleeding and requires extra vigilance by patients, who must take medicine at the same time. Daily. “Combination pills,” which include both progestin and estrogen, are much more commonly used.

“Oral contraceptives are safe, and they are safe for most people,” says Dr. Jonas Swartz, MD, an obstetrician and gynecologist at Duke University Health System. “There is good data that people can perform screening, using online tools or checklists, to determine if they are not a candidate for combination or single-pill use. progestins.”

Both Cadence, the company that makes the combination pill, and HRA Pharma have been in touch with the FDA for more than six years about getting approval to sell their over-the-counter drugs. Cadence, which has not yet received FDA approval to conduct a necessary clinical trial for its application, may have to wait another two years before it can.

Samantha Miller, Cadence’s co-CEO, said the FDA has halted the company’s “real-life use testing” – its study to determine how women use the drug in real-life settings – on pause. . She said the company is “actively working” with the agency “to overcome this regulatory hurdle by developing a user-friendly technology interface for our over-the-counter product.”

HRA Pharma, which was recently acquired by Perrigo, a multinational over-the-counter drug manufacturer based in Dublin, has been selling another progestin-only pill over the counter in the UK, where the drug is marketed. marketed under the name Hana. In the United States, the prescription drug being considered for over-the-counter approval is called Opill.

Cost is almost certainly an issue. Because the Affordable Care Act requires insurance companies to cover the cost of prescription birth control pills, people who have insurance and are taking Opill may not want to switch. HRA Pharma’s Ms Welgryn said the company is determined to make its products “affordable for consumers”. Cadence promised the same.

Oral contraceptives became associated with the women’s rights movement even before 1960, when the first oral contraceptive was approved by the FDA In the 1940s and 1950s, Margaret Sanger, founder of Planned Parenthood, has closely monitored research on birth control and funded some of it itself, according to a History of planned parenthood.

The initial pills include high doses of hormones and a risk of side effects; It took scientists more than a decade to recognize those risks and reduce the dosage. Carole Joffe, professor of obstetrics and gynecology at the University of California, San Francisco, says:

But the prospect of possibly separating the sexes from childbearing leaves women free to enter the workplace and set up their own specialized courses on their own timetable – a development economists say Harvard Claudia Goldin and Lawrence F. Katz called “The power of the pill.”

But it wasn’t until 1965, with its ruling in Griswold v. Connecticut, that the Supreme Court established the right to contraception – and then only to married people.

“It was revolutionary, because at my grandmother’s age, they had no other choice,” said Senator Murray of Washington.

For decades, pharmaceutical companies showed little interest in providing over-the-counter birth control pills. Oral contraceptives are hardly the big moneymakers, though if HRA or Cadence were to become the first to allow their pill to be used over-the-counter, it would get a temporary monopoly. in that market, to help the company recover research and development capital. cost.

In the 1980s, one company endorsed the idea but abandoned it, says Dr. Daniel Grossman, a reproductive health expert at the University of California, San Francisco. And the political and legal battle over Plan B, he said, has left drugmakers “cold feet”.

“They’ve seen how even if you’ve done the studies exactly the way the FDA has laid out,” he said, “you can still be blocked for political reasons.”

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