FDA Advisory Panel Strongly Backs Perrigo’s OTC Birth Control Pill

Pictured: Front of FDA headquarters/Grandbrothers/Adobe Stock

Pictured: Front of FDA headquarters/Grandbrothers/Adobe Stock

Wednesday, the FDA’s Nonprescription Drugs Advisory Committee and Obstetrics, Reproductive and Urologic Drugs Advisory Committee unanimously supported Perrigo’s bid to make its birth control drug Opill (norgestrel) available over-the-counter.

Voting 17–0, with no abstentions, the joint committee deemed that the benefits of allowing non-prescription use of the oral progestin-only contraceptive outweigh its risks.

“The benefits of moving Opill over the counter include the increased access to contraception, especially for those who face multiple barriers,” said Kathryn Curtis, a health scientist in the CDC’s Division of Reproductive Health, during the second day of the meeting in explaining her affirmative vote.

Making the drug available without prescription will also reduce unintended pregnancies and its associated health risks, as well as improve “reproductive autonomy,” especially for women, Curtis said.

The FDA is set to decide on Opill’s over-the-counter (OTC) bid later this year. The regulator is not bound to follow advisory committee recommendations, though it often does.

If approved, Opill would become the first daily birth control pill available without a doctor’s prescription.

Opill, a non-estrogen birth control pill containing 0.075 mg of norgestrel, was first approved in 1973 and has since collected some 50 years’ worth of scientific evidence backing its safety and efficacy.

“Safety was established 50 years ago when the original approval was made,” Curtis said. “The accumulating body of evidence since then has shown that these pills are safe with very few contraindications and long-term safety concerns.”

To support its proposal to make Opill a non-prescription drug, Perrigo submitted data from its OTC development program, which had been conducted over the past eight years. This included several Label Comprehension Studies showing that patients could understand Opill’s OTC label. Meanwhile, results of an actual use trial demonstrated that consumers could follow Opill’s label and take the drug correctly.

Perrigo also submitted a published pregnancy impact model, which found that making Opill available OTC could cut the number of unintended pregnancies in the U.S. by more than 30,000 annually.

Several major medical organizations across the country support making oral contraceptives available without prescriptions, including the American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians.

Wednesday’s overwhelming vote in support of Opill’s OTC bid follows an April ruling from a Texas federal judge that sought to block the sale of the abortion pill mifepristone, following a November 2022 lawsuit from the Alliance of Hippocratic Medicine against the FDA.

A few days later, the U.S. 5th Circuit Court of Appeals moved to block the ruling, but only partially. The appellate court retained the restrictions on mifepristone’s distribution, disallowing its delivery by mail. The following week, the Supreme Court granted the FDA’s appeal for a stay, which will keep mifepristone on the market while its case winds its way through the courts.

Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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