A drugmaker is now officially making the case for an over-the-counter birth control pill to be sold in the U.S. On Monday, the company HRA Pharma said it has submitted an application to the Food and Drug Administration to approve an OTC version of its existing contraceptive product. The move comes amid an ongoing effort by the Republican party to restrict women’s reproductive rights at the state level.
More than 60% of women between the ages of 15 and 49 are estimated to use some form of contraception regularly, with about 12% taking the pill. But many medical organizations and even lawmakers have called for the pill and other forms of hormonal contraception to be made OTC, arguing that the need for a prescription acts as a barrier to access. The primary justification for birth control pills to be prescription-only is that these treatments can raise the risk of rare but serious health problems, such as blood clots, and that doctors can best screen out patients most vulnerable to these risks. Advocates have countered that self-screening tools should be enough to keep an OTC version of the pill as safe and effective for eligible patients as it is currently. And these are the same arguments that the French-based pharmaceutical is making to the FDA.
“More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, in a statement Monday.
The company is specifically asking the FDA to switch the labeling of the drug Opill, a progestin-only contraceptive that’s taken daily. The move is timely given the recent Supreme Court decision to strip away the federal right to an abortion that was enshrined by Roe v Wade. But the timing of the application was unrelated to the decision, the company has said, according to the Associated Press. Typically, companies will submit for an expanded use of a drug only after having collected several years’ worth of relevant data.
While the application may have been a long time coming, the FDA’s pending decision looks to be more consequential than ever before. With abortion care set to be severely or completely curtailed in about half of the country, people’s lives may depend on reliable accessible contraception. And some GOP lawmakers or candidates have already started to entertain the idea of going after the use of contraceptive products as well, possibly through restricting its prescription drug coverage by public payers like Medicaid.
At least one other company is expected to file for approval of its own OTC pill later this year, according to the New York Times, while the FDA’s decision on HRA Pharma’s application may arrive within the next 10 months.