On the same day that the Food and Drug Administration allowed women over-the-counter access to one progestin-only birth control pill, Rep. Mariannette Miller-Meeks (R‑Iowa) introduced the OTC (Orally-Taken Contraceptive) Act in the U.S. House of Representatives. The bill has seven Republican women co-sponsors. Notably, Rep. Miller-Meeks is also a medical doctor. As I have, the American College of Obstetrics and Gynecology, the American Academy of Family Physicians, and the American Medical Association have long supported making all hormonal contraceptives over-the-counter available.
Last session, Miller-Meeks co-sponsored the “Allowing Greater Access to Safe and Effective Contraception Act,” which instructed the FDA to prioritize contraceptive makers’ applications for over-the-counter status. But the OTC Act goes much further. The bill directs the FDA to provide guidelines to makers of hormonal contraceptives intended to facilitate their application for over-the-counter approval.
The bill’s language appears inspired by how the FDA gradually nudged Emergent BioSolutions, the makers of Narcan naloxone nasal spray, to seek the agency’s approval for over-the-counter sales. In that case, the FDA told makers of Narcan, who could charge high prices to third-party payers for the prescription drug, that the agency was likely to approve a generic competitor for over-the-counter access. The company then sought approval for over-the-counter status. Providing guidelines to hormonal contraceptive manufacturers on how to expedite over-the-counter approval might have a similar effect.
Congress has the authority to order the FDA to reclassify all hormonal contraceptives as over-the-counter by a specific date. But this bill certainly helps move the ball in the right direction.