Lawsuit Alleges FDA’s Restrictions on Mifepristone Are Not Supported by Science
Chicago — Attorney General Kwame Raoul, with 11 attorneys general, today filed a federal lawsuit against the Food & Drug Administration (FDA) accusing it of singling out one of the two drugs used for medication abortion for excessively burdensome regulations, despite ample evidence proving the drug is safe.
Of the more than 20,000 drugs approved by the FDA, only 60 — including mifepristone — fall under a unique set of restrictions known as Risk Evaluation & Mitigation Strategies (REMS). REMS restrictions typically apply to inherently dangerous drugs such as opioids like fentanyl and high-dose sedatives used by psychiatric patients – not to drugs like mifepristone which have been safely used for over two decades. In the lawsuit, Raoul and the coalition assert the restrictions on prescribing and dispensing mifepristone are burdensome, harmful, unnecessary, and expose providers and patients to unnecessary privacy and safety risks.
“Despite the millions of patients who have safely used mifepristone for abortion care and miscarriage management, the FDA continues to categorize mifepristone as a dangerous drug requiring unnecessary restrictions,” Raoul said. “The science clearly shows that mifepristone is safe, which is why I am urging the FDA to remove these burdensome restrictions that limit access to safe and effective health care.”
The lawsuit asserts that the FDA exceeded its authority by continuing its unnecessary and burdensome restrictions on mifepristone. The lawsuit also argues that the FDA’s actions violate the constitutional principle of equal protection. Raoul and the coalition are asking the court to find the FDA’s REMS restrictions unlawful and to bar the federal agency from enforcing or applying them to mifepristone. It also seeks to ensure that mifepristone remains accessible.
Since its FDA approval, mifepristone has been safely used more than 5 million times in the U.S. In the lawsuit, Raoul notes that mifepristone is associated with fewer serious side effects and deaths than common drugs like Tylenol or Viagra, neither of which are regulated under REMS restrictions. Despite mifepristone’s strong safety record, the FDA has repeatedly declined to remove the REMS restrictions on the medication.
Under the FDA restrictions, health care providers and pharmacies must first complete a burdensome certification process before they are permitted to prescribe or dispense mifepristone. Additionally, both patients and providers must sign an agreement that states the patient has decided to take the drug to end a pregnancy, regardless of whether they are seeking an abortion or are being treated for a miscarriage. A copy of this agreement must be included in the patient’s medical records.
As Raoul and the coalition explain, this documentation can expose providers, pharmacists and patients to violence, harassment or abuse. It may also be used to threaten providers or patients with legal liability in states with extreme anti-abortion laws. While safeguards exist to protect the privacy of medical records, the abortion documentation remains in patients’ medical records and therefore creates a risk for patients who travel from out-of-state to obtain care, since it can be viewed by providers in their home state. Similarly, the certification requirement for providers and pharmacists creates liability exposure if they serve patients from other states with restrictive abortion laws, even if the provider is in full compliance with their state’s laws.
Joining Raoul in filing the lawsuit are the attorneys general of Arizona, Colorado, Connecticut, Delaware, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont and Washington.
