FDA weighs over-the-counter sale of birth control pills

FDA weighs over-the-counter sale of birth control pills

WASHINGTON — More than 60 years after the approval of the oral contraceptive that revolutionized women’s sexual health, the Food and Drug Administration received its first order to supply an over-the-counter contraceptive pill — much like the Supreme Court’s ruling overturning Roe v. Wade has placed access to contraceptives more explicitly at the center of the struggle over reproductive rights.

Paris-based HRA Pharma announced Monday that it has asked the U.S. Food and Drug Administration (FDA) to approve its pills, which are available by prescription, for over-the-counter sales in the United States. Cadence Health, another pill maker that has been in close dialogue with the Food and Drug Administration about converting the pill to an over-the-counter state, said it hopes to move closer to placing an order next year.

The timing of the FDA’s introduction of HRA Pharma, just weeks after the Supreme Court’s ruling, is a “really sad coincidence,” said Frederic Wellgren, the company’s head of strategy and innovation. “Birth control is not a solution to accessing an abortion,” she said.

Under normal circumstances, an application to sell a prescription drug without a prescription would go unnoticed in Washington. But birth control is a sensitive issue for FDA Cadence and HRA Pharma mired for years in the agency’s pre-application process, and the official application of HRA comes at a particularly fraught moment in the reproductive rights campaign.

Supreme Court ruling in Dobbs v. The Jackson Women’s Health Organization, which overturned Roe and abolished the constitutional right to abortion, included a simultaneous decision by Justice Clarence Thomas suggesting that the 1965 decision establishing the right to contraception should also be rescinded. On Friday, President Biden denounced Dobbs’ ruling as an “exercise in raw 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 Food and Drug Administration Commissioner Robert Califf asking for a “timely review” of any requests to take the over-the-counter pill. More than 100 Democrats have signed a bill requiring insurance companies to cover the cost of over-the-counter contraceptives. (The Affordable Care Act already requires insurance companies to cover prescription contraceptives.)

“As we witness the results and chaos of the Supreme Court’s decision, more families are looking to, ‘Well, how do I make sure I control my choices in life?'” Senator Patty Murray, D-Washington, chairperson, said. The Senate Health Committee is the main sponsor of this measure. “We want to make sure that not only women get access, but those who have difficulty granting it can access as well.”

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

Reproductive rights advocates also demand Mr Biden that the Food and Drug Administration move quickly in its review of over-the-counter contraceptives in light of Dobbs’ decision. Dana Singer, founder of the Contraceptive Access Initiative, a not-for-profit advocacy group, said experience with Covid-19 shows that the FDA “can act urgently during a public health emergency, which is what women are now facing with a reversal.” ru vs. Wade.”

But Mr Biden has taken a laissez-faire attitude toward the US Food and Drug Administration, and Jane 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 U.S. Food and Drug Administration (FDA) approved the over-the-counter sale of Plan B, an emergency contraceptive, to teenage girls age 16 and under — only to have Kathleen Sebelius, the Obama administration’s health secretary, take the very rare step of… invalidate it. The decision came after President Barack Obama expressed reservations about granting minors access to the property without parental consent. In the end, a federal judge overturned Mrs. Sibelius’ decision.

“Years of legal wrangling have finally pushed them to follow the science,” said Kelly Blanchard, president of Ibis Reproductive Health, a global nonprofit that partnered with HRA Pharma to conduct the research needed to apply. “Hopefully they will follow the flag and agree without age restrictions in this case.”

But the arrival of teens is likely to emerge as a sticking point. Leaders of the anti-abortion movement have not taken a position on the over-the-counter pill, but they are vehemently against giving it to minors without any adult interference.

I agree with Obama. “It makes sense that you shouldn’t sell these pills recklessly,” 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 was a problem.”

Nearly 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 the over-the-counter contraceptive pill as an easy and effective tool for women in rural, poor, and historically marginalized communities to avoid unwanted pregnancies, which in turn lowers the abortion rate.

Dobbs’ decision has highlighted the barriers that women, especially poor women, face in accessing contraceptives — a point made by Representatives Barbara Lee of California and Diana Diggett of Colorado, Democrats who lead the House’s pro-choice bloc. A letter they sent to Dr. Califf in March.

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

In a response dated May 18, Dr. Califf wrote that the Food and Drug Administration “recognizes the public health benefits of increased access to oral contraceptives.” He said decisions regarding approval of over-the-counter oral contraceptive status, “are guided by the best available science.”

Angela Musk, who runs #FreeThePill Youth Council, an advocacy group aligned with HRA Pharma, said young women, in particular, are keen on over-the-counter pills.

Maske, 25, said she was denied contraception while a freshman at Georgetown University, a Catholic institution whose Student Health Center provides contraception if needed for medical conditions, such as acne, “but not directly to prevent pregnancy,” according to to her website.

She said the policy made her feel as if she was being encouraged to lie, which she “felt shoddy and immoral.” She said the over-the-counter pills – which she notes are available in more than 100 countries – would have solved the problem.

Medical experts say birth control pills are among the safest and most well-studied drugs on the market, but having 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 suitable for over-the-counter use.

HRA Pharma pills are called a mini-pill, that is, they contain 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 US market for oral contraceptives, in part because the pills can cause unscheduled bleeding and require greater vigilance on the part of patients, who should They have to eat it at the same time. every day. “Combined pills” that contain both progestin and estrogen are commonly used.

“Oral contraceptives are safe, and they are safe medications for most people,” said Dr. Jonas Schwartz, an obstetrician and gynecologist at Duke University Health System. “There is good data that people can do screening using online tools or checklists, to determine if they are not a candidate for using combination pills or progestin-only pills.”

Cadence, which makes the combination birth control pill, and HRA Pharma have been communicating with the Food and Drug Administration for more than six years about obtaining approval to sell their pills without a prescription. Cadence, which has not received FDA approval to move forward with a clinical trial necessary to apply it, 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 experience” — its study to determine how women use the pills in a real setting — on hold. She said the company is “actively working” with the agency “to overcome this regulatory hurdle by developing an easy-to-use technology interface for our over-the-counter product.”

HRA Pharma, which was recently acquired by Perrigo, the Dublin-based multinational over-the-counter drug company, already sells its progestin-only pills without a prescription 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 certainly an issue. Because the Affordable Care Act requires insurance companies to cover the expense of prescription contraceptives, women who have insurance and already take Opill may not want to switch. Ms Wellgren of HRA Pharma said the company is determined to make its product “highly accessible to consumers”. Percussion made a similar promise.

Oral contraceptives became entangled with the women’s rights movement even before 1960, when the Food and Drug Administration approved the first birth control pills in the 1940s and 1950s, Margaret Sanger, the founder of Planned Parenthood, closely followed research on birth control and funded some of her own , according to the history of Planned Parenthood.

Early pills contained high doses of hormones and had a risk of side effects; It took scientists more than a decade to recognize these risks and reduce doses. Carol Joffe, a professor of obstetrics and gynecology at the University of California, San Francisco, said women’s rights advocates were “very keen on contraception, but very concerned about first-generation pills.”

But the prospect of being able to separate sex from childbearing freed women from entering the workplace and charting their own professional courses on their own schedule—a development that Harvard economists Claudia Goldin and Lawrence F. Katz have called “the power of a pill.”

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

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

For decades, drug companies have shown little interest in offering over-the-counter birth control pills. Oral contraceptives were hardly making much money, although if HRA or Cadence became the first to have a type of birth control pill approved for over-the-counter use, they would be given a temporary monopoly in that market, with the goal of helping the company recover research and development costs.

In the 1980s, a company took on the idea, but abandoned it, said Dr. Daniel Grossman, a reproductive health expert at the University of California, San Francisco. The political and legal battle over Plan B, he said, has given drug manufacturers “cold feet.”

“They saw how even if the studies were done exactly the way the Food and Drug Administration put it, you could still get banned for political reasons,” he said.

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