The FDA Will Consider Whether To Approve a Birth Control Pill for Over-the-Counter Use

On Monday, Paris-based drug company HRA Pharma sent a formal request to the Food and Drug Administration (FDA) asking that the regulatory agency approve birth control pills for over-the-counter availability. If approved, the drugs would be widely available without a prescription. 

While the application follows the Supreme Court’s decision to overturn Roe v. Wade (1973), ending the federal right to abortion, HRA Pharma told the Associated Press that the application is unrelated to current political events.

In its application, HRA Pharma argues that oral hormonal contraceptive pills have proven safe and effective over the 50 years that they have been available with a prescription. Thus, it is time to remove the barrier of a physician for patients who would like to purchase them directly. “For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” said Frederique Welgryn, an HRA executive.

Currently, birth control pills are the most popular hormonal birth control method in the United States. The CDC estimates that over 9 million women use birth control pills, and a study from the Guttmacher Institute found that 86 percent of U.S. women using birth control pills took them at least in part for pregnancy prevention. The remainder of women say they use the pills for noncontraceptive reasons, such as acne or to mitigate severe menstrual symptoms.

However, gaining a physician’s prescription for the drugs can be prohibitively expensive and time-consuming for many women—especially those who lack health insurance. Approving the nationwide sale of birth control without a prescription would grant many more women access to a safe, reliable method of preventing pregnancy without unnecessary bureaucratic hurdles.

HRA Pharma is specifically seeking the approval of a progestin-only pill for over-the-counter availability. Progestin-only pills