FDA Advisors Say Progestin-Only Birth Control Pill Safe for OTC Status

On May 9-10, 2023, the FDA convened a group of independent advisors to consider an over-the-counter (OTC) birth control pill for the first time. 

The meeting considered moving OPILL (norgestrel) Tablet, 0.075 mg (Laboratoire HRA Pharma) to OTC status. The pill, which would be sold by Perrigo with the brand name Opill, is a progestin-only pill (also called a mini-pill), meaning it does not contain estrogen like most birth control pills.

The American Medical Association and the American College of Obstetricians and Gynecologists support the contraceptive’s move to OTC status, while the Catholic Medical Association does not.

The FDA advisors voted unanimously at the conclusion of the meeting that the FDA should approve Opill for OTC status. “I think Opill has the potential to have a huge positive public health impact,” explains Kathryn Curtis, a committee member and health scientist with the CDC’s division of reproductive health.

While the FDA does typically follow advisory councils’ recommendations, the vote does not mean the FDA will change the drug’s status. Karen Murry, deputy director of the F.D.A.’s office of nonprescription drugs, states, “The FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting…. We can’t just approve it based on the experience in the prescription setting without the applicant doing adequate studies to look at what’s likely to happen in the nonprescription setting. But I wanted to again emphasize that F.D.A. does realize how very important women’s health is and how important it is to try to increase access to effective contraception for U.S. women.”

If approved for OTC status, the drug could be available OTC almost immediately depending on Perrigo’s ability to stock shelves.

Discussion Questions

1. Should the FDA approve Opill for OTC status? Why or why not? Consider the international status of the drugs.

2. If approved for OTC status, should any additional restrictions be imposed? Consider age restrictions and drugs that are kept behind the pharmacy counter versus those available in store aisles.

3. Are there other prescription drugs you believe should move to OTC status, or vice versa (OTC status to prescription)? Explain your answer(s).

Sources

Pam Belluck, “F.D.A. Advisers Say Benefits of Over-the-Counter Birth Control Pill Outweigh Risks,” nytimes.com, May 10, 2023

Alisha Haridasani Gupta, “A Birth Control Pill May Soon Be Available Over the Counter. Here’s What to Know.,” nytimes.com, May 10, 2023

Scott Hensley and Rob Stein, “Advisers to the FDA Back First Over-The-Counter Birth Control Pill,” npr.org, May 10, 2023

Rob Stein, “The FDA Considers First Birth Control Pill without a Prescription,” npr.org, May 9, 2023