FDA Weighs the First Application for Over-The-Counter Birth Control Pills

For the first time, a pharmaceutical company has asked the FDA for approval to sell a birth control pill over the counter in the U.S. The process is expected to take approximately 10 months.

The Paris-based company, HRA Pharma, submitted its application on Monday, and says the timing was unrelated to the recent Supreme Court decision to overturn Roe v. Wade.

Hormone-based birth control pills have been the most common method of birth control for women since the 1960’s, but have always required a doctor’s prescription. Health professionals have screened for conditions that raise the risk of rare, but dangerous, blood clots, but the French pharmaceutical intends to convince the FDA that women can screen themselves successfully.

Earlier this year, House Democrats requested a timely review by the FDA for any applications for OTC birth control pills, and over 100 Democrats signed a bill that would require insurance companies to cover the cost of OTC birth control pills.

“As we are seeing the outfall and the chaos of the Supreme Court decision, more families are looking to, ‘Well, how can I make sure I control my own choices in life?’” said Senator Patty Murray, Democrat of Washington, chairwoman of the Senate Health Committee and the lead sponsor of the measure. “We want to make sure that women not only get access, but those who have trouble affording it get access as well.”


Over the counter birth control has been available to other countries in South America, Asia and Africa. Last year, Paris-based HRA won U.K. approval for the first birth control pill available there without a prescription.

  • HRA’s pill, which would be sold under its original brand name, Opill, was acquired from Pfizer in 2014. It is expected to raise fewer safety concerns because it contains a single synthetic hormone, progestin, which blocks sperm from the cervix.
  • Most birth control pills contain progestin plus estrogen, and are associated with blood clot risk, causing the FDA to warn against their use in certain women already at risk for heart problems, such as those who smoke and are over 35.