United States Food and Drug Administration Approves First OTC Birth Control Pill

July 13, 2023
Photo of pills

Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States.

Director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, on the FDA’s approval of the birth control tablet Opill to be sold over-the-counter.

Why It Matters: On Thursday, the FDA cleared pharmaceutical company Perrigo's daily birth control pill Opill to be sold over-the-counter; Opill was first approved by the FDA in 1973 for prescription use only. The pill is now the first over-the-counter birth control option to be available in the U.S.; it is expected to be available for purchase by early 2024 with no age requirements on sales. Did you know? The first birth control pill was approved by the FDA in 1960.

  • The cost of the over-the-counter pill has not been announced, however, The Associated Press reports, "Over-the-counter medicines are generally much cheaper than prescriptions, but they aren't typically covered by insurance."
  • The FDA notes that nearly half of pregnancies in the U.S. are unintended and explains that access to nonprescription Opill "may help reduce the number of unintended pregnancies and their potential negative impacts."
  • In approving Opill for over-the-counter use, the FDA was looking to determine whether the pill could be effectively and safely used by consumers by only their understanding of the drug's labeling, without help from a healthcare professional. Some concerns raised in the process included "whether a women with certain underlying medical conditions would understand they shouldn't take the drug" (The AP). However, the FDA ultimately said, "Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product."

FDA Approves First Nonprescription Daily Oral Contraceptive

First over-the-counter birth control pill gets FDA approval

by Jenna Lee,