November 11, 2022

Multistate AG Coalition Urges Approval of Nation’s First OTC Birth Control Pill

Lori Kalani, Bernard Nash

Cozen O'Connor

+ Follow Contact

Facebook

Send

Embed

Cozen O'Connor

Twenty-one AGs submitted a letter to the FDA urging the agency to approve HRA Pharma, SA’s pending application for Opill, which, if, approved, would become the country’s first ever birth control pill available without a prescription.
In the letter, the AGs assert that the pill should be approved because access to birth control confers significant benefits, including lower maternal mortality rates, less poverty, higher levels of physical and mental health, and more economic freedom and opportunity. The AGs also note that progestin-only birth control pills like Opill have been found to be safe and effective for most users, and that the nation’s major medical associations agree that birth control pills should be available OTC.
In addition, the AGs affirm that an OTC birth control pill would remove barriers that are commonly faced in obtaining birth control, such as coordination of clinic appointments and navigation of limitations on the amount of birth control that can be purchased monthly. The letter explains that OTC birth control would particularly benefit people from vulnerable populations, as barriers to access are most often faced by people of color, low-income families, and individuals living in rural areas, who are more often underinsured or uninsured.
The AGs urge the FDA that access to OTC birth control is more important than ever in light of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which the AGs argue has created uncertainty regarding reproductive healthcare.

Send Print Report

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.