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 to supply a birth control pill over the counter — just as the Supreme Court’s decision to overturn Roe v. Wade has put access to contraception more squarely at the heart of the clash over reproductive rights.
A Paris-based company, HRA Pharma, announced on Monday that it asked the F.D.A. to authorize its pill, which is available by prescription, for over-the-counter-sales in the United States. Cadence Health, another pill manufacturer that has been in close dialogue with the F.D.A. about switching its pill to over-the-counter status, said it hopes to move closer to submitting an application in the coming year.
The timing of HRA Pharma’s F.D.A. submission, just weeks after the Supreme Court decision, is “a really sad coincidence,” said Frédérique Welgryn, the company’s chief strategic and innovations officer. “Birth control is not a solution for abortion access,” she said.
Under ordinary circumstances, filing an application to sell a prescription drug over the counter might go unnoticed in Washington. But birth control is a delicate issue for the F.D.A. Cadence and HRA Pharma have been mired for years in the agency’s pre-application process, and HRA’s formal application comes at an especially fraught moment in the campaign for reproductive rights.
The Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, which struck down Roe and eliminated the constitutional right to abortion, included a concurring decision by Justice Clarence Thomas suggesting that the 1965 decision that established a right to contraception should also be overturned. On Friday, President Biden denounced the Dobbs ruling as “an exercise in raw political power,” and vowed to expand access to reproductive health care.
On Capitol Hill, scores of House Democrats signed a letter earlier this year to F.D.A. Commissioner Robert Califf requesting a “timely review” of any applications to take birth-control pills over the counter. More than 100 Democrats have signed on to 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 are seeing the outfall and the chaos of the Supreme Court decision, more families are looking to, ‘Well, how can I make sure I control my own choices in life?’” said Senator Patty Murray, Democrat of Washington, chairwoman of the Senate Health Committee and the lead sponsor of the measure. “We want to make sure that women not only get access, but those who have trouble affording it get access as well.”
HRA Pharma officials said they expect an F.D.A. decision in about 10 months, which is typical for over-the-counter applications. The F.D.A. declined to comment.
Supporters of reproductive rights are also calling on Mr. Biden to have the F.D.A. move quickly on its review of over-the-counter contraceptives in light of the Dobbs decision. Dana Singiser, a founder of the Contraceptive Access Initiative, a nonprofit advocacy group, said the experience with Covid-19 shows that the F.D.A. “can work with urgency during a public health emergency, which is what women are facing right now with the overturning of Roe v. Wade.”
But Mr. Biden has taken a hands-off posture toward the F.D.A. Jen Klein, who advises the president on gender policy, told reporters on Friday that the agency “has to go through its process.” And if history is any guide, the path to approval will be bumpy.
In 2011, the F.D.A. approved the over-the-counter sale of Plan B, an emergency contraceptive, to teenagers 16 and younger — only to have Kathleen Sebelius, then the health secretary in the Obama administration, take the exceedingly rare step of overruling 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 got them to follow the science,” said Kelly Blanchard, the president of Ibis Reproductive Health, a global nonprofit group that partnered with HRA Pharma to conduct the research needed to submit the application. “We hope they follow the science and approve without an age restriction in this case.”
But access for teenagers is likely to emerge as a sticking point. Leaders of the anti-abortion movement have not taken a position on over-the-counter birth control pills, but they strongly oppose giving them to minors without any adult involvement.
“I agree with Obama; it’s 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 daughters, he understood that taking adults out of the equation is a problem.”
Roughly half of all pregnancies in the United States are unintended, according to the Guttmacher Institute, a research organization that supports abortion rights. Reproductive-rights activists view an over-the-counter birth control pill as an easy and effective tool for women in rural, poor and historically marginalized communities to avoid unwanted pregnancies, which in turn reduces the abortion rate.
The Dobbs decision has cast a spotlight on the barriers women, especially poor ones, face in gaining access to contraception — a point that Representatives Barbara Lee of California and Diana DeGette of Colorado, the Democrats who chair the House Pro-Choice Caucus, made in a letter they sent to Dr. Califf in March.
“Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” said the letter, also signed by 57 other Democrats. “These barriers are disproportionately borne by people of color, immigrants, L.G.B.T.Q.+ people, low-income individuals, young people and people in rural communities.”
In a May 18 reply, Dr. Califf wrote that the F.D.A. “acknowledges the public health benefits of increased access to oral contraceptives.” Decisions on whether to approve over-the-counter 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 manages the #FreeThePill Youth Council, an advocacy group aligned 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 its website.
The policy, she said, made her feel as though she were being encouraged to lie, which “felt icky and immoral.” Over-the-counter pills — which she noted are available in more than 100 countries — would have solved the problem, she said.
Medical experts say that birth control pills are among the safest and most-studied medicines on the market, but that 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 that oral contraceptives are appropriate for over-the-counter use.
HRA Pharma’s pill is a so-called mini pill, meaning it contains only 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. market for oral contraceptives, partly because the pills can cause unscheduled bleeding and require greater vigilance on the part of patients, who must take them at the same time every day. “Combination pills,” which include both progestin and estrogen, are much more commonly used.
“Oral contraceptives are safe, and they 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 do screening with, either online tools or checklists, to determine if they are not candidates for using combined pills or progestin-only pills.”
Both Cadence, which makes a combination pill, and HRA Pharma have been communicating with the F.D.A. for more than six years about getting approval to sell their pills over the counter. Cadence, which has not received F.D.A. approval to proceed with a clinical trial that is essential to its application, may have to wait another two years before it can do so.
Samantha Miller, the co-chief executive of Cadence, said the F.D.A. 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 purchased by Perrigo, a multinational maker of over-the-counter pharmaceuticals based in Dublin, already sells its progestin-only pill over the counter in Britain, where the drug is marketed under the name Hana. In the United States, it is sold by prescription as Opill.
Cost is almost certain to be an issue. Because the Affordable Care Act requires insurers to cover the expense of prescription contraceptives, women who have insurance and are already taking Opill may be loath to switch. Ms. Welgryn of HRA Pharma said the company is determined to make its product “very affordable for consumers.” Cadence has made a similar promise.
Oral contraceptives had become entwined with the women’s rights movement even before 1960, when the first birth control pill was approved by the F.D.A. In the 1940s and 1950s, Margaret Sanger, the founder of Planned Parenthood, closely followed research on birth control and funded some of it herself, according to a Planned Parenthood history.
The early pills included high doses of hormones and carried the risk of side effects; it took scientists more than a decade to recognize those risks and lower the doses. Feminists were “very eager for contraception, but very wary about the first generation of pills,” said Carole Joffe, a professor of obstetrics and gynecology at the University of California, San Francisco.
But the prospect of being able to separate sex from childbearing freed women to enter the workplace and to chart their own professional courses on their own timetable — a development that the Harvard economists, Claudia Goldin and Lawrence F. Katz, have called the “power of the pill.”
But it was not until 1965, with the ruling in the landmark case of Griswold v. Connecticut, that the Supreme Court established a right to contraception — and then only for married people.
“It was revolutionary, because in my grandmother’s age, they had no choices,” said Senator Murray of Washington.
For decades, pharmaceutical companies demonstrated little interest in offering birth control pills over the counter. Oral contraceptives were hardly blockbuster moneymakers, although if either HRA or Cadence becomes the first to have its type of pill approved for over-the-counter use it will be granted a temporary monopoly on that market, intended to help the company recoup research and development costs.
In the 1980s, a company flirted with the idea, but abandoned it, said Dr. Daniel Grossman, an expert in reproductive health at the University of California, San Francisco. And the political and legal battle over Plan B, he said, gave pharmaceutical manufacturers “cold feet.”
“They saw how even if you had done the studies exactly the way F.D.A. had laid them out,” he said, “you could still get blocked for political reasons.”
#FDA #Weigh #OvertheCounter #Sale #Contraceptive #Pills