Women who are looking to get birth control medication without a prescription will have to wait longer than previously expected.
The FDA has pushed back a decision date on a proposed over-the-counter switch of Perrigo’s prescription birth control drug Opill by 90 days, Perrigo said Wednesday.
Perrigo had previously expected an approval in the first half of 2023, but the exact original FDA action date was never disclosed. Perrigo’s HRA Pharma applied for the Rx-to-OTC switch on July 11, and such reviews typically take 10 months.
In addition to its decision delay, the FDA also postponed a planned joint meeting by its Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee to discuss Perrigo’s application. The conference was previously scheduled for Nov. 18. No new date has been set, Perrigo said.
The delay comes as the FDA needs more time to review additional information requested from Perrigo related to the application.
Typically, an Rx-to-OTC switch application must include efficacy and safety data to show that the drug works in the nonprescription setting. In some cases, new clinical trials may be necessary.
What’s more, drugmakers must also provide data that demonstrate consumers can understand how to use the drug properly without the supervision of a healthcare professional. Certain postmarketing surveillance data are also required.
Perrigo will “continue to work collaboratively with the FDA to ensure a timely and thorough review,” the company said.
Opill’s Rx-to-OTC pitch draws much attention on the heels of the U.S. Supreme Court’s decision in June to overturn the Roe v. Wade case that once legalized abortion nationwide. If eventually approved, the non-estrogen pill would become the first daily contraception drug available without the need for a prescription in the U.S.
As for Perrigo, the company recently created a new “women’s health” category in its financial reports to include related drugs from HRA Pharma after the $1.9 billion buyout in May.
In the first six months of 2022, that department generated $20.2 million sales in the U.S. and $37.4 million outside the U.S. HRA Pharma’s main women’s health product is ella, an emergency OTC contraceptive that’s available only by prescription in the U.S. but can be obtained without a prescription in Europe.