The FDA Will Soon Decide Whether to Make a Birth Control Pill Available Over the Counter

A drugmaker is now formally making the case for an over-the-counter contraception tablet to be bought within the U.S. On Monday, the corporate HRA Pharma mentioned it has submitted an software to the Food and Drug Administration to approve an OTC model of its present contraceptive product. The transfer comes amid an ongoing effort by the Republican get together to limit girls’s reproductive rights on the state stage.

More than 60% of ladies between the ages of 15 and 49 are estimated to make use of some type of contraception commonly, with about 12% taking the tablet. But many medical organizations and even lawmakers have called for the tablet and different types of hormonal contraception to be made OTC, arguing that the necessity for a prescription acts as a barrier to entry. The major justification for contraception capsules to be prescription-only is that these remedies can increase the chance of uncommon however critical well being issues, equivalent to blood clots, and that docs can finest display screen out sufferers most weak to those dangers. Advocates have countered that self-screening instruments ought to be sufficient to maintain an OTC model of the tablet as protected and efficient for eligible sufferers as it’s at present. And these are the identical 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,” mentioned Frédérique Welgryn, chief strategic operations and that innovation officer at HRA Pharma, in a statement Monday.

The firm is particularly asking the FDA to change the labeling of the drug Opill, a progestin-only contraceptive that’s taken every day. The transfer is well timed given the latest Supreme Court decision to strip away the federal proper to an abortion that was enshrined by Roe v Wade. But the timing of the appliance was unrelated to the choice, the corporate has mentioned, in response to the Associated Press. Typically, firms will submit for an expanded use of a drug solely after having collected a number of years’ price of related knowledge.

While the appliance could have been a very long time coming, the FDA’s pending determination appears to be like to be extra consequential than ever earlier than. With abortion care set to being severely or fully curtailed in about half of the nation, folks’s lives could rely on dependable accessible contraception. And some GOP lawmakers or candidates have already began to entertain the concept of going after the use contraceptive merchandise as nicely, probably via proscribing its prescription drug protection by public payers like Medicaid.

At least one different firm is anticipated to file for approval of its personal OTC tablet later this yr, in response to the New York Times, whereas the FDA’s determination on HRA Pharma’s software could arrive inside the subsequent 10 months.