Illinois AG Raoul, Others Sue FDA Over Safety Of Abortion Medication

CHICAGO — Illinois Attorney General Kwame Raoul and others filed a lawsuit on Friday against the Food and Drug Administration, claiming that the federal agency has singled out a drug used for prescription abortions as being harmful.

Raoul, along with 11 other attorneys general, filed the suit against the FDA and cited evidence that mifepristone is safe for women to use despite the agency’s excessively burdensome regulations against it.

In the lawsuit, Raoul and the coalition of attorneys general assert the restrictions on prescribing and dispensing mifepristone are burdensome, harmful, unnecessary, and expose providers and patients to unnecessary privacy and safety risks. 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), a news release announcing the lawsuit on Friday said.

The news release states that 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, the attorneys general claim in the suit.

“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 in a statement released on Friday. “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.”

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.

The lawsuit claims 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, according to the news release.

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.

Mifepristone has been safely used more than 5 million times in the U.S. since it was approved by the FDA. In the lawsuit, Raoul cites scientific evidence 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.

Yet, Raoul says, despite mifepristone’s strong safety record, the FDA has repeatedly declined to remove the REMS restrictions on the medication.

Under the FDA restrictions, healthcare providers and pharmacies must first complete a burdensome certification process before they are permitted to prescribe or dispense mifepristone.

In addition, 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, the news release said.

Raoul and his colleagues claim that 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, Raoul and other attorneys general said. The certification requirement for providers and pharmacists creates liability exposure if they serve patients from other states with restrictive abortion laws, Raoul said, even if the provider is in full compliance with their state’s laws.