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

If approved, the drug could increase access to effective birth control.

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 are historically less popular than combination pills—which contain both estrogen and progestin—as they must be taken at the same time every day, whereas combination pills are typically effective during a broad window of time. For this reason, progestin-only pills are generally considered to have a lower effectiveness rate than other birth control pills. However, progestin-only pills contain a significantly lower risk of blood clots, thus making them an ideal over-the-counter for patients who have not first consulted with a physician. 

HRA Pharma's appeal to the FDA is just one part of the larger political project to make birth control pills available over the counter. Currently, 12 states and the District of Columbia allow for the over-the-counter sale of birth control pills. The policies are broadly popular, with supporters highlighting the drugs' safety and the importance of reducing unplanned pregnancy.

Many adamantly pro-life politicians support over-the-counter birth control access. In 2019, Sen. Ted Cruz (R–Texas) made headlines after replying to a tweet from Rep. Alexandria Ocasio-Cortez (D–N.Y.) calling for over-the-counter birth control. "I agree," he wrote. "Perhaps, in addition to the legislation we are already working on together to ban Members of Congress from becoming lobbyists, we can team up here as well. A simple, clean bill making birth control available over the counter. Interested?" 

Following the release of the Dobbs decision, Democratic lawmakers unveiled legislation that, assuming the FDA approves an over-the-counter birth control pill, would require insurers to cover the full out-of-pocket cost for the pill. In a press release, one of the bill's sponsors, Rep. Ami Bera (D–California), wrote, "As a doctor, I know access to affordable contraception is critical for women's reproductive health." He continued, "I'll keep fighting to ensure women have access to quality, affordable healthcare – including access to full reproductive health services."

As more states ban or severely restrict abortion access, politicians and drug companies alike seem geared up to support over-the-counter birth control access. Among politicians, access to such drugs could prove to be an unlikely place for bipartisan support.