FDA panel to discuss OTC birth control pills in May

A Food and Drug Administration advisory panel will meet in May to help decide whether the agency should approve an over-the-counter birth control pill.

Opill, manufactured by HRA Pharma, would be the first-ever progestin-only, daily birth control pill available over-the-counter in the U.S. The meeting will be held May 9-10.

The company submitted its application to switch from prescription only to over-the-counter in July. The agency in October postponed a previously scheduled meeting to review additional information requested by the manufacturer.

Hormone-based birth control pills are the most popular oral contraceptive, and they have been in use since the 1960s. They have also always required a prescription, usually so providers can screen for risk of rare blood clots. 

Opill has been used with a prescription since its approval in 1973.

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But Opill — also known as a minipill — only contains progestin, rather than the combination of progestin and estrogen, so it reduces the clotting risk. Still, the combination pill is more effective than the minipill, and the vast majority of consumers who use oral birth control pills use the combination pill. 

Over-the-counter birth control 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.

There’s been renewed attention to easing access to oral contraceptives since the Supreme Court overturned Roe v. Wade last year.

While many conservative groups say they only want to limit or ban abortion, Justice Clarence Thomas argued that the Supreme Court “should reconsider” its past rulings codifying the right to contraception access.