Ibis responds to federal court decisions on mifepristone registration and availability

April 2023

Cambridge, MA, April 10, 2023 – On Friday, April 7, 2023, a judge in a Texas federal court released a ruling in Alliance for Hippocratic Medicine v. FDA. The ruling places a stay on the FDA’s approval of mifepristone and seeks to remove it from the market nationwide. The same day a judge in Washington state issued a decision in a separate lawsuit filed on behalf of 17 states and Washington, DC; this decision contradicts the Texas court ruling and prevents the FDA from making any changes to the availability of mifepristone. The federal government has until Friday, April 14, to respond to the Texas ruling and for now mifepristone continues to be available

Kelly Blanchard, President of Ibis Reproductive Health, released the following statement in response to the decision:   

The Texas judge’s court decision ignores decades of scientific and clinical evidence demonstrating that mifepristone is a safe and effective medicine. The FDA reviewed extensive safety and effectiveness data and the process for its approval was sound; millions of people have used mifepristone medication abortion safely. This unprecedented move defies the FDA’s authority and rigorous scientific process to ensure people’s access to safe, effective medications. The case never should have been heard in the first place, and this is just another attempt to take away our rights to access abortion care when we need it.   

At the same time, we are heartened by the Washington district court’s decision underscoring the long history of safe use of mifepristone and protecting access to this essential medicine.  

We call on the Biden administration to do everything in its power to reaffirm the FDA’s authority to determine the safety and effectiveness of the medicines we need and use every day and ensure continued access to mifepristone. 

Mifepristone is used in more than half of abortion procedures across the United States. This decision could limit access to this safe and effective abortion care option and will most greatly impact communities that already face added barriers to care, including Black people, Indigenous peoples, AANHPI and Latine people, LGTBQ+ people, immigrants, those working to make ends meet, and people living in geographically isolated areas. Access to abortion is critical for bodily autonomy and people’s ability to control their lives and futures. Everyone should have access to the full range of abortion care options. 

This latest attack is part of a larger political agenda to ban abortion nationwide and to take away essential health care from our communities. We will continue our work to identify innovative ways to expand access to abortion so that all people can access high-quality abortion care and choose the method that is best for them. 

While mifepristone is extremely safe and should be available to anyone who wants it, it is important to note that there are two WHO-recommended medication abortion regimens: mifepristone followed by misoprostol, or misoprostol alone. This decision does not impact the current or future availability of misoprostol in the United States. Ibis research shows that misoprostol alone also is highly effective, and more effective than previously thought. For more information about misoprostol alone, please see our resource hub