08.19.19

Gardner, Ernst Call for Over-the-Counter Contraceptives

Washington, D.C. – Senators Cory Gardner (R-CO) and Joni Ernst (R-IA) wrote to Food and Drug Administration (FDA) Acting Commissioner Norman Sharpless urging the FDA to promote access to over-the-counter oral contraceptives.

The burdensome, inconsistent prescription-to-over-the-counter switch process keeps manufacturers from developing contraceptives that could be sold over-the-counter without a prescription. The senators requested that the FDA utilize all regulatory tools available to improve that process and encourage access.

Senators Gardner and Ernst also introduced legislation in March which encourages manufacturers of contraceptives to file an application with the Food and Drug Administration to sell their products over-the-counter.

Note: Full letter available here.

The letter reads in full: 

Dear Acting Commissioner Sharpless:

We write today to request that the Food and Drug Administration (FDA) work to facilitate access to over-the-counter (OTC) contraceptives. We suggest that FDA work with manufacturers to provide greater regulatory certainty and a streamlined pathway for prescription birth control to be available over-the-counter, similar to FDA’s actions related to improving access to naloxone, a treatment for opioid overdoses.

In January 2019, the FDA announced a plan to spur development of OTC naloxone by coordinating pre-approved consumer friendly labeling and streamlining regulatory pathways. Medical experts have long recognized the safety and efficacy of naloxone as an opioid overdose treatment; however, regulatory barriers in the prescription-to-over-the-counter switch (Rx-to-OTC switch) process have prevented improved access.

We applaud the FDA for taking these groundbreaking steps to combat the opioid epidemic, and urge that these tools also be used to encourage the development of OTC contraceptives.

Despite medical providers strongly advocating for OTC contraceptive access, existing burdensome regulatory processes deter manufacturers from undertaking the arduous process to conduct the additional clinical studies and develop an Rx-to-OTC switch product. 

We recognize the public health benefits of providing greater access and choice for American families to contraceptives. For many women across the country, the added strain from a prescription requirement means hours lost from work or their personal lives and increased stress. While some states have undertaken steps to increase access at the pharmacy counter, those efforts fall short of meaningful, widespread adoption of OTC contraceptive availability.

We encourage the FDA to work with manufacturers to increase convenient access to oral contraceptives that have long been determined to be safe and effective. We will continue to advocate in the Senate for passage of our legislation, S. 930, the Allowing Greater Access to Safe and Effective Contraception Act, which incentivizes manufacturers to go through the OTC approval process.

We call upon the FDA to use its existing authorities and regulatory tools to promote a framework that encourages development of OTC contraceptives and recognizes the public health benefits of increasing access to OTC contraceptives for women and families across the country.

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Cory Gardner is a member of the U.S. Senate serving Colorado. He sits on the Energy & Natural Resources Committee, the Foreign Relations Committee, the Commerce, Science, & Transportation Committee, and is the Chairman of the Subcommittee on East Asia, the Pacific, and International Cybersecurity Policy.