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Editor's Pick

Rep. Miller‐​Meeks’ OTC Act Might Nudge the FDA and Drug Makers Towards Making All Hormonal Contraceptives Over‐​The‐​Counter

Jeffrey A. Singer

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.

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