WASHINGTON — More than 60 years after the approval of oral contraceptives revolutionized women’s sexual health, the Food and Drug Administration has received its first application for over-the-counter birth control pills — just as the Supreme Court’s decision to overturn Roe v. Wade put access to contraception more clearly at the heart of the reproductive rights clash.
A Paris-based company, HRA Pharma, announced Monday that it has asked the FDA to allow its prescription pill to be sold over the counter in the United States. Cadence Health, another pill maker that is in close dialogue with the FDA about switching its pills to over-the-counter status, said it hopes to move closer to filing an application next year.
The timing of HRA Pharma’s FDA filing, just weeks after the Supreme Court ruling, is “a really sad coincidence,” said Frédérique Welgryn, the company’s chief strategy and innovation officer. “Birth control is not a solution to abortion access,” she said.
Under ordinary circumstances, filing an application to sell a prescription drug without a prescription can go unnoticed in Washington. But birth control is a sensitive issue for the FDA Cadence and HRA Pharma have been mired in the agency’s pre-application process for years, and HRA’s formal filing comes at a particularly tense time in the campaign for reproductive rights.
The Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, which overruled Roe and eliminated the constitutional right to abortion, included a concurring decision by Justice Clarence Thomas that suggested the 1965 decision establishing a right to contraception should also be overturned. On Friday, President Biden condemned Dobbs’ decision as an “exercise of crude political power” and pledged to expand access to reproductive health care.
On Capitol Hill, dozens of House Democrats signed a letter earlier this year to FDA Commissioner Robert Califf requesting “timely review” of all over-the-counter birth control pill applications. More than 100 Democrats have signed a bill requiring 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 see the fallout and chaos of the Supreme Court’s decision, more families are looking at, ‘Well, how can I make sure I’m in control of my own life choices?'” said Sen. Patty Murray, D-Washington, chair of the House Health Care Committee. Senate and lead sponsor of the measure. “We want to make sure that not only do women get access, but those who have trouble affording it get access as well.”
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 push the FDA to move quickly to review over-the-counter contraceptives in light of the Dobbs decision. Dana Singiser, founder of the Contraceptive Access Initiative, a nonprofit advocacy group, said the experience with Covid-19 shows that the FDA “can work with urgency during the public health emergency that women face right now with overturning Roe v. Wade.
But Mr. Biden has taken a hands-off stance on the FDA. Jen Klein, who advises the president on gender policy, told reporters Friday that the agency “has to go through 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, to teenagers 16 and younger — only to have Kathleen Sebelius, then the Obama administration’s health secretary, take the extremely rare step of overturning its decision , after President Barack Obama expressed reservations about giving minors access to the drug without parental consent. Ms. Sebelius was eventually overruled by a federal judge.
“Years of legal wrangling finally made them follow the science,” said Kelly Blanchard, president of Ibis Reproductive Health, a global nonprofit group that partnered with HRA Pharma to conduct the research needed for the filing. “We hope they follow the science and approve without an age limit in this case.”
But access for teenagers is likely to prove a hindrance. Anti-abortion leaders have not taken a position on over-the-counter birth control pills, but strongly oppose giving them to minors without an adult’s involvement.
“I agree with Obama; it’s common sense not to sell these pills recklessly,” said Christy Hamrick, spokeswoman for Students for Life, an anti-abortion group. “As a father of two daughters, he understood that taking adults out of the equation was 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 over-the-counter birth control pills as an easy and effective tool for women in rural, poor and historically marginalized communities to avoid unwanted pregnancies, which in turn lowers abortion rates.
Dobbs’ decision shed light on the barriers women, especially poor women, face in accessing contraception — a point that Reps. Barbara Lee of California and Diana DeGette of Colorado, the Democrats who chair the House Select Caucus, made in a letter they sent to Dr. Calif in March.
“Despite decades of proven safety and effectiveness, people still face enormous barriers to obtaining birth control because of systemic inequities in our health care system,” said the letter, which was also signed by 57 other Democrats. “These barriers are disproportionately experienced by people of color, immigrants, LGBTQ+ people, low-income people, young people, and people in rural communities.”
In a May 18 response, Dr. Calif wrote that the FDA “recognizes the public health benefits of increased access to oral contraceptives.” Decisions about whether to approve OTC status for oral contraceptives, he said, are “guided by the best available science.”
Young women in particular are eager for over-the-counter pills, said Angela Maske, who runs the #FreeThePill Youth Council, an advocacy group affiliated with HRA Pharma.
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 his website.
The policy, she said, made her feel like she was being encouraged to lie, which “feels disgusting and immoral.” Over-the-counter pills — which she noted are available in more than 100 countries — would solve the problem, she said.
Medical experts say birth control pills are among 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 the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians, say oral contraceptives are safe to use without a prescription.
HRA Pharma’s pill is the so-called mini-pill, which means it only contains the hormone progestin, which plays a role in the menstrual cycle and pregnancy.
The mini-pill is widely used in Britain but accounts for less than 10 percent of the U.S. oral contraceptive market, in part because the pills can cause unscheduled bleeding and require greater vigilance on the part of patients who must take them one at a time. same time every day. “Combination pills” that include both progestin and estrogen are much more commonly used.
“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’s good data that people can screen themselves with, or online tools or checklists, to determine if they’re candidates for combination pills or progestin-only pills.”
Both Cadence, which makes the combination pill, and HRA Pharma have been communicating with the FDA for more than six years to get approval to sell their pills over the counter. Cadence, which has not received FDA approval to proceed with a clinical trial essential to its application, may have to wait another two years before it can do so.
Samantha Miller, Cadence’s co-CEO, said the FDA has put the company’s “actual-use trial” — its study to determine how women use the pill in a real-world setting — on hold. 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 bought by Perrigo, a multinational over-the-counter drug maker based in Dublin, already sells its progestin-only pill over the counter in Britain, where the drug is sold under the name Hana. In the United States, it is sold by prescription as Opill.
Cost is almost certainly an issue. Because the Affordable Care Act requires insurers to cover the cost of prescription contraceptives, women who have insurance and already take Opill may not want to switch. HRA Pharma’s Ms Welgryn said the company was determined to make its product “very accessible to consumers”. Cadence made a similar promise.
Oral contraceptives have been associated with the women’s rights movement since before 1960, when the first birth control pill was approved by the FDA. In the 1940s and 1950s, Margaret…
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