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FDA weighs first-ever application for over-the-counter birth control pills in the wake of Roe’s fall

The Food and Drug Administration is reviewing a first-of-its-kind application from HRA Pharma, which is seeking permission to sell its birth control without a prescription.

If green-lit by the agency, Opill would become the first daily, hormonal birth control pill sold over the counter in the United States, the company announced Monday morning, broadening access to millions of people who have struggled to obtain a prescription.

The submission of the application follows more than six years of studies the company has run with thousands of subjects to prove to the FDA that people can understand the label on the drug and use it correctly without a doctor’s guidance. The company is also arguing that there’s a public health case for its approval as there are millions of unintended pregnancies every year and abortion is becoming increasingly inaccessible.

“When you bring a product over the counter, you have to prove the benefits outweigh the risks. It’s a rigorous and long process but we feel that this is what needs to be done,” Frédérique Welgryn, the chief strategic operations and innovation officer at HRA Pharma, told POLITICO in an interview. “It matters more now than ever. So I’m really hoping that the FDA will look at this thoroughly and that the decision will be based on science. If that’s the case, I’m sure there will be a pill available over the counter very soon.”

The FDA’s normal timeline for responding to such applications, however, is at least 10 months, meaning it could take until mid-2023 for the drug to be on shelves.

Better access to birth control has been a top demand of activists in the lead-up to the Supreme Court decision overturning Roe v. Wade and in the weeks since the ruling, with demonstrations staged outside the White House and around the country asking the Biden administration to “free the pill.”

A national study of adult women found that nearly 30 percent of those who sought a birth control prescription face barriers to obtaining one, with the most common hurdles being a lack of health insurance, difficulty traveling to a clinic or pharmacy, and not having a regular doctor. Another study found that Texas patients who obtained birth control pills over the counter in Mexico were more likely to keep up with taking them over time than those who had to get a prescription in Texas.

Minors on their parents’ health insurance often fear that getting a prescription will show up on their family’s statement of benefits — one of the reasons HRA Pharma is asking the FDA to allow the pill to be sold with no age restrictions.

“We believe people under 18 would benefit from better access to contraception and we included a number of adolescents in our studies,” Welgryn said.

Reproductive rights researchers and advocates say that should the pill win the FDA’s blessing, they will keep fighting to make sure it’s covered by insurance with no copays even when bought over the counter — a battle that will involve both federal and state officials.

“We want updated guidance from HHS to make sure the over-the-counter birth control is covered under the Affordable Care Act,” said Kelly Blanchard, the president of Ibis Reproductive Health. “Congress could also ensure that through legislation.”

Blanchard added that while making the pill more accessible could help prevent unintended pregnancies, she doesn’t see FDA approval as a solution for the recent elimination of abortion in more than a dozen states.

“People have a right to and deserve all reproductive health care, including the full range of contraceptive methods and abortion,” she said.

Another company, Cadence Health, also plans to ask the FDA to approve its own application for over-the-counter birth control but still has more research to complete and its submission may still be years away.