After governor’s repeated calls on FDA months ago to remove unnecessary barriers to access the abortion pill, FDA takes action 

LANSING, MI — On Jan 4th, Governor Gretchen Whitmer celebrated the U.S. Food and Drug Administration’s (FDA) decision to make medication abortion available at pharmacies with a prescription, cutting red tape that prevents women from accessing reproductive health care. In July 2022, she sent a letter calling on the FDA to reduce burdensome restrictions on mifepristone, a safe, effective medication abortion pill. She followed up in August, and now it is getting done, building on the governor’s leadership at the state and federal level to protect and expand reproductive freedom. 

“We need to use every tool in our toolbox at the state and federal levels to ensure people have control over their own bodies and access to reproductive health care no matter where they live or who they are,” said Governor Whitmer. “Last year, I called on the FDA multiple times to remove burdensome restrictions on mifepristone, abortion medication that is safer than Tylenol, Viagra, and many other widely used medications. On Jan 4th, I am proud to see the FDA take action. As some state governments take steps to control women’s bodies, enacting extreme laws and restrictions, we must keep finding creative ways to protect reproductive freedom including cutting red tape so women can access the care they need.” 

The letter can be viewed here. 

Mifepristone Background 

Since 2000, the FDA has approved the use of mifepristone for abortion but imposed restrictions on its prescription and use through a Risk Evaluation and Mitigation Strategy (REMS).  On July 21, the governor first called on the FDA to remove the REMS restrictions altogether. In August, she renewed her call to cut red tape on mifepristone. Now, it is getting done. 

By eliminating the REMS provision that prevented pharmacies from dispensing mifepristone, the FDA is removing another burden that threatens timely and essential reproductive health care. Last year, the FDA announced it would not enforce the in-person dispensing requirement for medication abortion, including mifepristone, through the duration of the COVID-19 public health emergency. Now the agency has gone a step further, tweaking the REMS to permanently remove the in-person dispensing requirement and allowing certified pharmacies to dispense mifepristone.  

The medical community has generally opposed REMS requirements for mifepristone because they place an unnecessary burden on patients who want to access safe, effective medicine. In fact, mifepristone is safer than Tylenol, Viagra, and many other widely used medications. Leading medical organizations have found that mifepristone is both safe and effective and have advocated for the removal of the REMS.