FDA schedules joint advisory committee meeting to consider first over-the-counter birth control pill

The FDA has set a date to review what could become the first over-the-counter birth control pill approved for use in the US.

HRA Pharma, recently acquired by Dublin-based Perrigo, filed back in July to make its daily progestin-only Opill available without a prescription. On Monday, the regulatory agency scheduled a joint meeting of its Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the application on Nov. 18 from 9 am to 5:30 pm ET.

The news comes less than two weeks after CEO David Wright stepped down after five years at the helm, leaving chief commercial officer Martyn Hilton to run the company in the interim. Wright has since founded his own consulting firm called DJW Advisory, according to LinkedIn.

David Wright

“Given the significant progress HRA has made, along with my personal goals after leading HRA for more than five years, I believe now is the time to step away from the business,” he said in a news release last month.

Opill was first approved back in 1973, more than a decade after the first birth control pill. But even with a raft of contraceptives on the market, almost a third of women who’ve ever tried to get access to birth control pills, patches and rings have experienced difficulty, according to HRA. The company believes an OTC option could help prevent some of the nearly 3 million unwanted pregnancies in the US each year.

“For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach,” OBGYN Melissa Kottke said in a news release a couple of months ago.

Martyn Hilton

HRA’s progestin-only pill Hana is already approved for OTC use in Britain, and the company hopes it’s just a matter of time for an OK in the US.

The American College of Obstetricians and Gynecologists has previously pointed out that progestin-only hormonal methods are “generally safe” and carry a low risk of blood clotting, a potential side effect that’s more likely after taking estrogen products. The researchers said about three years ago that “women are capable of using self-screening tools to determine their eligibility for hormonal contraceptive use.”

Frédérique Welgryn

Most women in the US use contraceptives at some point in their lifetimes, and birth control pills are the second most popular option under female sterilization, according to the CDC.

HRA’s chief strategic operations and innovation officer Frédérique Welgryn told the New York Times a couple of months ago that the OTC application for Opill has been in the works for quite some time, and that the timing of the Supreme Court’s decision to overturn Roe v. Wade was just a “sad coincidence.”

While the FDA isn’t required to follow an adcomm’s recommendations, it typically does.

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