Connect with us

Hi, what are you looking for?

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.

You May Also Like

Editor's Pick

Jeffrey A. Singer The Food and Drug Administration announced this morning that it has granted marketing approval for the over‐​the‐​counter sale of one type...

Editor's Pick

Marc Joffe Last week the House Appropriations Subcommittee on Transportation, Housing and Urban Development, and Related Agencies approved a Fiscal Year 2024 budget that forbids...

Editor's Pick

Jack Solowey and Jennifer J. Schulp Last Wednesday, July 12, an updated version of the Lummis‐​Gillibrand Responsible Financial Innovation Act (RFIA) became public. The...

Editor's Pick

Gene Healy Last week, the New York Times ran a front-page story admiring President Biden’s political acumen on culture-war issues (“Biden Sidesteps Any Notion...