Over 65 million Women Are Counting on the FDA to Maintain Access to Mifepristone

Access to reproductive care continues to be the focus of consequential decisions made in Washington D.C., including by perhaps unlikely people, like the potential leader of the U.S. Food and Drug Administration (FDA).

On March 6, 2025, the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee is holding a confirmation hearing on the nomination of Dr. Martin Makary for the next Commissioner of the FDA. The FDA Commissioner has a critical role in our health care system and in women’s health and access to reproductive health services. The commissioner is charged with overseeing federal policy on mifepristone, a drug that patients rely on for a wide range of women’s health issues, as well as to treat complications from diabetes, high blood pressure, metabolic syndrome, and Cushing’s syndrome.

As with any nominee, we expect Senators to do their job to test Dr. Makary on his willingness to follow the data and the science on mifepristone’s safety and efficacy to ensure patients continue to have access to the drug.

The FDA first approved mifepristone more than 20 years ago. Since that time, the FDA has relaxed restrictions on the use of mifepristone as doctors and health experts continue to gather robust evidence demonstrating that mifepristone is one of the safest drugs on the market. The changes the FDA has implemented over time have included allowing prescriptions through telemedicine, expanding the types of health care providers who can prescribe the drug, and increasing the timeframe for use.

Mifepristone is safer than Tylenol and Viagra — two drugs that patients are allowed to use anytime, anywhere. Maintaining the current level of access to mifepristone is particularly important following the fall of Roe v. Wade. The drug assists in almost two-thirds of all abortion procedures nationwide. Current access standards allow women to obtain mifepristone in states where abortion is banned and use it safely in the comfort of their own homes, where they have the support of family and friends.

Mifepristone is also a safe and effective drug to manage and treat a number of other common women’s health issues, including miscarriage care, fibroids, and postpartum hemorrhage. Mifepristone prevents deadly complications from miscarriages, including excessive bleeding that can lead to sepsis, and the need for surgery or hospitalization. Since the fall of Roe v. Wade, pregnancy complications are becoming more dangerous in states that have banned access to abortion care like mifepristone. Texas, for example, has seen over a 50% rise in sepsis cases for women hospitalized when they lost their pregnancies in the second trimester since 2021. Sepsis is life-threatening and can cause permanent damage to multiple organs. This means all 65 million women of reproductive age in the U.S. are depending on the FDA to maintain access to mifepristone.

Decisions around access to drugs like mifepristone should continue follow the data and the science, without interference from politicians. Women must be able to work with their doctors to access the medications they need, when and where they need them. For decades, the FDA has set the gold-standard in the world when it comes to implementing a scientifically rigorous process for drug approval and access.