The FDA has set a date to review what could become the first over-the-counter birth control pill approved in the United States.
HRA Pharma, recently acquired by Dublin-based Perrigo, applied in July to make its daily progestogen Opill available without a prescription. On Monday, the regulatory agency scheduled a joint meeting of its Over-the-Counter Drugs Advisory Committee and the Obstetric, Reproductive and Urological Drugs Advisory Committee to review the application for Nov. 18 from 9 a.m. to 5:30 p.m. 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 lead the company on an interim basis. Wright has since founded his own consulting firm called DJW Advisory, according to LinkedIn.
“Given the significant progress HRA has made, as well as my personal goals after leading HRA for over five years, I believe now is the time to step away from the business,” he said. in a press release last month.
Opill was first approved in 1973, more than a decade after the first birth control pill. But even with a slew of contraceptives on the market, almost a third of women who have ever tried to access birth control pills, patches and rings have encountered difficulty, according to HRA. The company estimates that an OTC option could help prevent some of the nearly 3 million unintended pregnancies in the United States each year.
“For many, a birth control pill may be the best option for them, but requiring a prescription is an unnecessary hurdle that can put it out of reach,” OBGYN Melissa Kottke said in a press release a few months ago.
HRA’s progestin-only pill Hana is already approved for over-the-counter use in Britain, and the company hopes it’s only a matter of time for an OK in the US.
The American College of Obstetricians and Gynecologists has previously pointed out that progestogen-only hormonal methods are “generally safe” and carry a low risk of blood clotting, a potential side effect that is more likely after taking estrogen products. Researchers said about three years ago that “women are able to use self-screening tools to determine their eligibility for hormonal contraceptive use.”
Most women in the United States use contraceptives at some point in their lives, and birth control pills are the second most popular option for female sterilization, according to the CDC.
Frédérique Welgryn, Director of Strategic Operations and Innovation at HRA say it New York Times a few months ago that the OTC application for Opill had been pending for some time and the timing of the Supreme Court’s decision to overturn Roe vs. Wade was just a “sad coincidence”.
Although the FDA is not required to follow an adcomm’s recommendations, it generally does.