The Approval Process for OTC Birth Control

In a major breakthrough, the first FDA-approved, over-the-counter birth control pill is now for sale on store shelves!

A second version of an over-the-counter birth control pill, a combined oral contraceptive, COC, is progressing through the FDA approval process.

Can people currently get birth control pills over the counter?

In a major breakthrough, 2024 marks the first year that birth control pill users are able to buy Opill, often called the “mini-pill,” online and on store shelves without a prescription. A second type of birth control pill — a combined oral contraceptive (COC), the most common form of the pill — is expected to also be sold on store shelves within a few years, once it successfully completes the FDA application process.

The big picture: how the FDA decides whether to allow over-the-counter status

The progestin-only pill, Opill, successfully completed the FDA process in 2023 and is available for sale online and in stores.

The other application, for the combined oral contraceptive pill, which is taken by 95% of pill users in the United States — is still in the FDA testing phase.

The FDA application process for a switch to over-the-counter status is illustrated below:

When will the FDA Advisory Committee (AdCom) meet to discuss the pill over the counter and make a recommendation?

The progestin-only “mini-pill”  —  Approved!

The pharmaceutical company HRA Pharma submitted its formal application for the mini-pill in 2022. The FDA Advisory Committee meeting was held in May 2023, followed by FDA approval in July 2023.

The combined birth control pill —  FDA OTC switch approval process

The pharmaceutical company Cadence OTC is expected to submit its formal application in 2026, which would be followed by an Advisory Committee meeting in 2027. At this time, Cadence is working with the FDA and completing pre-application research. Once the OTC application is submitted to the FDA it usually takes 10-12 months for the review process to be completed.

The Advisory Committee (AdCom) is convened by the FDA to make a recommendation about approving this over-the-counter switch application. This is also a time when public commentary is entertained. The AdCom is very powerful, given the FDA typically follows its recommendations.

The AdCom meeting is usually scheduled six to eight months after the full OTC application is submitted.

In the case of Opill, the progestin-only oral contraceptive, the AdCom voted unanimously in favor of approval. A few months later, the FDA followed the AdCom’s guidance and approved Opill for on-the-shelf status without restrictions.

For further information, visit the FDA’s web page about the AdCom.

How can I stay updated?

CAI will post updates to the approval process on this page and on X (fka Twitter) @thepillotc. 

For media inquiries and/or to join CAI’s press list, contact Loretta Kane at Loretta@CaminoPR.com