The FDA’s Nonprescription Drugs Advisory Committee and Obstetrics, Reproductive and Urologic Drugs Advisory Committee have given their unanimous go-ahead for Perrigo’s birth control drug, Opill (norgestrel), to be made available over-the-counter. This is a major win for the company, and a great step forward in making birth control more accessible and affordable for everyone.
The joint committee voted unanimously – 17-0, with no abstentions – in favor of allowing non-prescription use of the oral progestin-only contraceptive due to the perceived benefits outweighing the risks.
The advantages of making Opill available over the counter are undeniable, according to Kathryn Curtis, a health scientist in the CDC’s Division of Reproductive Health. By removing the need for a prescription, access to contraception is greatly increased, particularly for those facing multiple obstacles. Curtis proudly cast her affirmative vote in recognition of the importance of this decision.
Making the drug available without prescription could bring a host of benefits, particularly for women. Not only would it reduce the risk of unintended pregnancies and associated health risks, but it could also improve reproductive autonomy and give women more control over their own bodies. According to Curtis, it would be a huge step forward in terms of sexual health.
The looming decision of the FDA on Opill’s OTC bid is set to arrive later this year, with the regulator usually following the advice of its advisory committee. Will the FDA follow suit this time? All eyes are on the agency to see what their verdict will be.
If approved, Opill would make history as the first over-the-counter birth control pill available for daily use – giving people more control over their reproductive health.
For over 50 years, the non-estrogen birth control pill known as Opill has been helping women make informed decisions about their reproductive health. First approved in 1973, this pill contains 0.075 mg of norgestrel and has since been backed by a wealth of scientific evidence that attests to its safety and efficacy. With Opill, women can trust that they’re making a responsible choice when it comes to contraception.
For half a century, oral contraceptives have been celebrated for their safety, offering the public a reliable form of contraception with few side effects and contraindications. According to Curtis, the growing body of evidence has only affirmed the pill’s safety since its introduction, offering peace of mind to those who use it.
Perrigo submitted extensive evidence from an eight-year development program to back its proposal to make Opill a non-prescription drug. This data included Label Comprehension Studies which showed consumers could understand Opill’s OTC label, as well as the results of an actual use trial which demonstrated that people could follow the instructions and use the drug correctly.
Perrigo recently presented a study that concluded that making Opill available over-the-counter could significantly reduce the number of unintended pregnancies in the United States each year, with estimates showing a reduction of over 30,000.
Making oral contraceptives available without prescriptions is a cause that has gained strong support from several prominent medical organizations across the United States. The American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians have all thrown their weight behind the movement, recognizing the importance of providing easier access to these medications.
On Wednesday, Opill’s bid to make the abortion pill mifepristone available over-the-counter was overwhelmingly approved by the public. This follows a ruling in April by a Texas federal judge that attempted to prevent the sale of mifepristone, after the Alliance of Hippocratic Medicine filed a lawsuit against the FDA in November 2022.
In an attempt to restrict mifepristone’s distribution, the U.S. 5th Circuit Court of Appeals attempted to block a ruling allowing it to be delivered by mail. However, their attempts were thwarted when the Supreme Court granted the FDA’s appeal for a stay, keeping mifepristone on the market while the case is being processed. This stay will ensure that mifepristone remains available for those who need access to it.