WASHINGTON – More than 60 years after the adoption of oral contraceptives revolutionized women’s sexual health, the Food and Drug Administration has received its first request to supply an over-the-counter birth control pill, as the decision has made. of the Supreme Court to set aside Roe v. putting access to contraception more directly at the center of the shock over reproductive rights.
A Paris-based company, HRA Pharma, announced Monday that it had asked the FDA to authorize its pill, which is available by prescription, for over-the-counter sales in the United States. Cadence Health, another pill maker that has maintained a close dialogue with the FDA about changing its pill to over-the-counter status, said it hopes to get closer to filing an application next year.
The timing of HRA Pharma’s FDA filing, a few weeks after the Supreme Court decision, is “a sad coincidence,” said Frédérique Welgryn, the company’s strategic and innovation director. “Birth control is not a solution for access to abortion,” she said.
Under normal circumstances, filing an application to sell an over-the-counter drug may go unnoticed in Washington. But birth control is a sensitive issue because FDA Cadence and HRA Pharma have been suppressed for years in the agency’s pre-application process, and HRA’s formal application comes at a particularly difficult time. the campaign for reproductive rights.
The Supreme Court ruling in Dobbs v. The Jackson Women’s Health Organization, which overturned Roe and removed the constitutional right to abortion, included a concurrent decision by Judge Clarence Thomas that suggested that the 1965 decision establishing the right to contraception. On Friday, President Biden denounced Dobbs’ ruling as “an exercise in raw political power” and vowed to expand access to reproductive health care.
On Capitol Hill, dozens of House Democrats signed a letter this year to FDA commissioner Robert Califf, calling for a “timely review” of any request to take over-the-counter birth control pills. More than 100 Democrats have signed a bill that obliges insurance companies to cover the cost of over-the-counter birth control. (The Affordable Care Act already requires insurers to cover prescription contraceptives).
“As we are seeing the excess and chaos of the Supreme Court decision, more families are looking,‘ Well, how can I make sure I control my own choices in life? ’” Said Sen. Patty Murray, “We want to make sure that women not only have access to it, but also those who have trouble affording it.”
HRA Pharma officials said they expect an FDA decision in about 10 months, typical for over-the-counter applications. The FDA declined to comment.
Proponents of reproductive rights are also calling on Mr. Biden for the FDA to act swiftly in its review of over-the-counter contraceptives in light of Dobbs’ decision. Dana Singiser, founder of Contraceptive Access Initiative, a nonprofit advocacy group, said experience with Covid-19 showed that the FDA “can work urgently during a public health emergency, which is where women are currently facing the rupture of Roe against Wade.
But Mr Biden has taken a disconnected stance towards the FDA Jen Klein, who advises the president on gender policy, told reporters on Friday that the agency “must go through its process”. And if history is a guide, the road to approval will be bumpy.
In 2011, the FDA approved the over-the-counter sale of Plan B, an emergency contraceptive, to teens 16 and under, just to get Kathleen Sebelius, then Obama administration health secretary, to take the plunge. rare to overturn his decision after President Barack Obama expressed reservations about giving drug access to minors without parental consent. Mrs. Sebelius was finally overturned by a federal judge.
“Years of legal disputes eventually led them to pursue science,” said Kelly Blanchard, president of Ibis Reproductive Health, a global nonprofit group that partnered with HRA Pharma to conduct the research needed to present the application. “We hope they follow science and pass it without age restriction in this case.”
But access for teens is likely to emerge as a point of contention. Leaders of the anti-abortion movement have not positioned themselves on over-the-counter birth control pills, but are strongly opposed to giving them to minors without the involvement of an adult.
“I agree with Obama; it is common sense not to recklessly sell these pills, ”said Kristi Hamrick, a spokeswoman for Students for Life, an anti-abortion group. “As a father of two, he understood that getting adults out of the equation is a problem.”
About half of all pregnancies in the United States are unwanted, according to the Guttmacher Institute, a research organization that supports abortion rights. Reproductive rights activists see an over-the-counter birth control pill as an easy and effective tool for people in rural, poor, and historically marginalized communities to prevent unwanted pregnancies, which in turn reduce the abortion rate.
Dobbs ’decision has highlighted the barriers women, especially the poor, face in accessing contraception, a point that representatives Barbara Lee of California and Diana DeGette of Colorado, the Democrats presiding over the Caucus Pro-Choice of the House, raised a letter they sent to Dr. Califf in March.
“Despite decades of proven safety and effectiveness, people still face immense barriers to achieving birth control due to systemic inequalities in our health care system,” the letter, also signed by 57 other Democrats, said. “These barriers are disproportionately borne by people of color, immigrants, LGBTQ + people, low-income people, young people and people from rural communities.”
In a May 18 response, Dr. Califf wrote that the FDA “recognizes the public health benefits of increased access to oral contraceptives.” Decisions on whether to approve the over-the-counter sales status of oral contraceptives, he said, “are guided by the best science available.”
Young people, in particular, crave over-the-counter pills, said Angela Maske, who runs the #FreeThePill Youth Council, a advocacy group.
Ms Maske, 25, said she was denied contraception while a student at Georgetown University, a Catholic institution whose student health center provides contraception if needed for medical conditions, such as acne, “but not directly for contraception,” according to its website.
Politics, he said, made her feel like she was being encouraged to lie, which “felt nasty and immoral.” He said over-the-counter pills, which he noted are available in more than 100 countries, would have solved the problem.
Medical experts say birth control pills are among the safest and most studied drugs on the market, but getting the necessary prescription can be a barrier to accessing them. Several major medical organizations, such as the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians, say oral contraceptives are suitable for over-the-counter use.
The HRA Pharma pill is a so-called mini pill, that is, it only contains 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 per cent of the US oral contraceptive market, in part because the pills can cause unscheduled bleeding and require more vigilance on the part of patients, who have them. to take at the same time. every day. “Combination pills,” which include progestin and estrogen, are used much more commonly.
“Oral contraceptives are safe and are safe medications for most people,” said Dr. Jonas Swartz, an obstetrician and gynecologist at Duke University Health System. “There is good data with which people can do screening, either with online tools or checklists, to determine if they are not candidates to use combination pills or progestin-only pills.”
Both Cadence, which makes a combined pill, and HRA Pharma have been in contact with the FDA for more than six years to get approval to sell their over-the-counter pills. Cadence, who has not received FDA approval to continue with a clinical trial that is essential for its application, may have to wait two more years before it can do so.
Samantha Miller, Cadence’s executive co-director, said the FDA has suspended the company’s “actual use test,” its study to determine how women use the pill in a real environment. He said the company is “actively working” with the agency “to overcome this regulatory hurdle by developing an easy-to-use technological interface for our over-the-counter product.”
HRA Pharma, which was recently bought by Perrigo, a multinational over-the-counter pharmaceutical manufacturer based in Dublin, already sells another type of over-the-counter progestin-only pill in Britain, where the drug is marketed under the name Hana . In the United States, the prescription drug that is considered for over-the-counter approval is called Opill.
Cost is almost certain to be an issue. Because the Affordable Care Act requires insurers to cover the cost of prescription contraceptives, people who have insurance and are already taking Opill may be reluctant to change. Ms Welgryn of HRA Pharma said the company is committed to making its product “very affordable for consumers”. Cadence has made a similar promise.
Oral contraceptives had become intertwined with the women’s rights movement even before 1960, when the first birth control pill was approved …