LAS VEGAS (KLAS) — Nevada Attorney General Aaron Ford announced Friday that Nevada has joined a multistate federal lawsuit against the Food and Drug Administration accusing it of placing unlawful and unnecessary restrictions on a medication abortion drug.
The lawsuit accuses the FDA of singling out mifepristone, one out of two drugs used in medication abortions, for “excessively burdensome regulation” despite evidence that the drug is safer than Tylenol, the Office of the Attorney General said.
“While our country continues to grapple with the fact that abortion rights were stripped away from many Americans, we must stand against actions that would further restrict this right,” Ford said. “The FDA’s regulations regarding mifepristone do not protect those seeking abortions, but they do make reproductive health care harder to access.”
The lawsuit said that the FDA exceeded its authority and violated the constitutional principle of equal protection and asked the court to find the current restrictions on mifepristone unlawful and bar the agency from enforcing them on the drug.
The attorneys general also filed a preliminary injunction asking the court to pause the restrictions on mifepristone while the case continues, the Office of the Attorney General said.
The attorney general’s office said that out of the more than 20,000 drugs approved by the FDA, only 60, including mifepristone, fall under a unique set of restrictions known as the Risk Evaluation & Mitigations Strategies (REMS).
REMS restrictions are supposed to apply to inherently dangerous drugs such as opioids and high-dose sedatives used by psychiatric patients, the attorney general’s office said.
The attorneys general stated in the lawsuit 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. The attorney general also notes that according to the FDA zero deaths can be attributed to mifepristone during its entire history of use in the U.S.
To prescribe mifepristone, healthcare providers must be certified by the drug distributor in advance. To receive the prescription, patients must sign an agreement that certifies that they have decided to take the drug to end their pregnancy, whether they are seeking an abortion or are being treated for a miscarriage, the attorney general’s office said.
A copy of the agreement must be included in the patient’s medical records. The lawsuit said that the restrictions on mifepristone are “unduly burdensome, harmful, and unnecessary and expose providers and patients to unnecessary privacy and safety risks.
The attorney general’s office said that disclosing the provider’s certification and the patient’s certification, which are required by the FDA, could expose those involved to violence, harassment, or abuse.
The lawsuit, led by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum, was filed in U.S. District Court for the Eastern District of Washington. Alongside Washington, Oregon, and Nevada, the attorneys general of Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, New Mexico, Rhode Island, and Vermont also joined the lawsuit.
