Health Care

FDA schedules meeting on OTC birth control pill application

A one-month dosage of hormonal birth control pills is displayed in Sacramento, Calif., Aug. 26, 2016.

The Food and Drug Administration (FDA) has scheduled a joint meeting to discuss pharmaceutical company Perrigo’s application for what could be the first over-the-counter (OTC) daily birth control pill available in the U.S., the company announced Monday.

The joint meeting will be held on Nov. 18 with the FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, according to Perrigo.

If approved by the FDA, Perrigo’s progestin-only daily pill would be the first non-prescription birth control pill available in the U.S. Perrigo filed its application to move its birth control pill from prescription to OTC in July.

The FDA declined to provide further comment on the meeting when reached by The Hill.

Consumer Healthcare Products Association (CHPA), a U.S. health care trade association, welcomed news of the FDA’s scheduled meeting.


“Pathways like Rx-to-OTC switch are instrumental in carrying out that mission on behalf of our member companies and American consumers,” said CHPA’s CEO Scott Melville. “We are pleased to see FDA evaluating broadened access to oral contraception and we look forward to sharing industry perspectives at this joint Committee meeting in November.”

Many countries in Latin America, Asia and Africa already allow for OTC birth control pills to be sold.

Perrigo filed its application just weeks after the Supreme Court overturned Roe v. Wade, leading to several states in the U.S. enacting total or near-total abortion bans. Supreme Court Justice Clarence Thomas’s concurring opinion sparked concerns that protected access to contraceptives could also be overturned.

The House in July passed the Right to Contraception Act, with eight Republicans joining Democrats in voting “yes.” The bill would codify access to contraception — including oral birth control, condoms and intrauterine devices — on the federal level.

Senate Democrats Ed Markey (Mass.), Patty Murray (Wash.), Mazie Hirono (Hawaii) and Tammy Duckworth (Ill.) sought unanimous consent to quickly pass the bill in July, but were blocked by Republican Sen. Joni Ernst (Iowa), though she herself has expressed support for expanded birth control access. Ernst argued that the bill went beyond just guaranteeing access to contraception.