FDA considering approval of first over-the-counter birth control pill

US health regulators meeting next week on request to make Opill birth control pills available without a prescription

Accessing birth control pills could soon become a lot easier in America.

Advisers to the Food and Drug Administration (FDA) will meet next week to evaluate drugmaker HRA Pharma's application for its decades-old daily birth control pill Opill to be sold in the U.S. without requiring a prescription.

The public meeting is one of the final steps before the FDA makes a decision, but concerns raised by the agency in an initial review published Friday indicate the approval is not guaranteed.

Opill birth control package

Advisers to the Food and Drug Administration meet next week to review drugmaker Perrigo's application to sell a decades-old pill over the counter. The two-day public meeting is one of the last steps before an FDA decision.  (Perrigo via AP / AP Newsroom)

France-based HRA Pharma, owned by Perrigo Co., submitted the application last year to sell Opill as an over-the-counter medication. The company acquired the progestin-only daily birth control pill from Pfizer in 2014, but it is not marketed in the U.S.


Hormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s. They have always required a prescription, generally so health professionals can screen for conditions that raise the risk of rare, but dangerous, blood clots.

But HRA argues that removing the prescription requirement would improve access to the contraceptive method, which is "more effective at preventing pregnancy than all current methods" available over the counter.

birth control pills

A one-month dosage of hormonal birth control pills is displayed in Sacramento, Calif., Aug. 26, 2016. A drug company is seeking U.S. approval for the first-ever birth control pill that women could buy without a prescription.  (AP Photo/Rich Pedroncelli / AP Newsroom)

"For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach," obstetrician-gynecologist Melissa Kottke said in a statement at the time of application last year. 


"Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health."

A sign for the Food and Drug Administration

A sign for the Food and Drug Administration is displayed outside its offices in Silver Spring, Md., Dec. 10, 2020. The FDA is weighing whether to allow an oral contraceptive to be sold in the U.S. over the counter. (AP Photo/Manuel Balce Ceneta, File / AP Newsroom)

But in its review posted Friday, the FDA raised several concerns about studies of Opill, citing problems with the reliability of some of the company’s data and raising questions about whether women with certain medical conditions would correctly opt out of taking it. It also noted signs that study participants had trouble understanding the labeling instructions. 


The panel meeting next week will vote on whether the risks of making Opill available over the counter outweigh the potential risks, but the vote is not binding. The FDA's final decision is expected this summer.

The Associated Press contributed to this report.