Oral Contraceptive Gets Unanimous Recommendation for OTC Use from FDA Advisory Panel

A key US Food and Drug Administration advisory panel today voted unanimously that Opill (Perrigo Company), a daily progestin-only oral contraceptive, should be made available for over-the-counter (OTC) use, the company announced.

The recommendation to the FDA, the result of a unanimous 17 to 0 vote without abstentions, was based on 2 days of discussion that included data presentations by Perrigo, regarding the balance of benefit and risk in making the contraceptive available without a prescription for the prevention of unintended pregnancy. The committee decided that patients, including pre-teens and young teenagers, will be able to follow Opill's labeled instructions without guidance from a health care provider, according to the company.

While the joint recommendation of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee is nonbinding, if the FDA elects to follow it, Opill would become the first and only contraceptive pill in the US available OTC. An FDA decision is expected sometime during the summer.

"Today's vote to recommend a switch of Opill to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the US," said Perrigo President and Chief Executive Officer Murray S. Kessler.

Noting that the unanimous vote reflects the strength of the data presented on safe and effective use, Frederique Welgryn, Perrigo global vice president for women's health said the FDA's approval for OTC use "would address a key unmet need for contraceptive access, be a groundbreaking expansion for women's health nationwide and a step forward toward ensuring people can have improved access to contraception without unnecessary barriers."

The FDA's approval for OTC use "would address a key unmet need for contraceptive access, be a groundbreaking expansion for women's health nationwide and a step forward toward ensuring people can have improved access to contraception without unnecessary barriers."

The company's announcement cites data that show nearly one-third of adult US women who have ever tried to obtain a prescription or refill for a contraceptive pill, patch, or ring reported difficulties doing so.

Research findings presented during the 2-day meeting included data from label comprehension studies and an actual use trial that showed that consumers of different ages used Opill correctly based on the label, including following instructions for daily dosing. In the use trial, adherence to taking the pill daily was no different from published data on oral contraception adherence in the prescription setting, the company said.

Opill contains 0.075 mg norgestrel, approved by the FDA in 1973 and used to prevent pregnancy by millions of women in the U.S. since.

According to Perrigo, OTC oral contraception has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians.