Attorney General Phil Weiser urges federal judge to end unlawful, unnecessary restrictions on mifepristone

Attorney General Phil Weiser urges federal judge to end unlawful, unnecessary restrictions on mifepristone

Oct. 11, 2024 (DENVER) - Attorney General Phil Weiser is urging a federal judge in Washington state to rule that the Food and Drug Administration's significant restrictions on the abortion medication mifepristone are unlawful, and to order the FDA to go back to the drawing board on regulating the drug.

Last year, Weiser joined other state attorneys general in filing a lawsuit in the U.S. District Court for the Eastern District of Washington over the FDA's regulations, saying they create unnecessary barriers to the drug. The judge in the case already granted the attorneys general's request for a preliminary injunction in April of 2023, barring the FDA from doing anything to reduce the availability of the medication abortion drug mifepristone in 17 states and the District of Columbia.

In the ruling granting their request for a preliminary injunction, the judge found that the FDA likely did not follow the requirements in the law when it placed significant restrictions on mifepristone.

The summary judgment motion filed late Thursday argues that the FDA is aware of decades of data conclusively showing that mifepristone is safe and effective, and that medical experts have long opposed the FDA's restrictions on the drug. By keeping the restrictions on mifepristone in place, the states argue that the FDA is unnecessarily and unlawfully limiting access to a drug that is safer than Tylenol.

"With threats to reproductive freedom increasing, I will do everything in my power to protect abortion rights and access to reproductive health care," Weiser said. "This action is necessary to ensure anyone seeking medication abortions and effective treatment of miscarriages can get the care they need."

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, or REMS. REMS restrictions are supposed to apply to inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiatric patients, among others.

To prescribe mifepristone, health care providers must be specially certified by the drug distributor in advance. To receive the prescription, patients and providers must sign an agreement that certifies the patient has decided to take the drugs to end their pregnancy - regardless of whether they are seeking an abortion or are being treated for a miscarriage, which is another common use for mifepristone. A copy of this agreement must be included in the patient's medical records. To dispense mifepristone, pharmacies must also be specially certified before they can fill a prescription. The attorneys general suing the FDA say these regulations do not hold up to scientific and legal scrutiny.

Earlier this year, the U.S. Supreme Court unanimously overturned a ruling by a Texas court that would have removed mifepristone from the market. The lawsuit filed in Washington state has proceeded in federal court while the Texas case was appealed up to the Supreme Court.

In addition to Colorado, attorneys general for Arizona, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, Washington state, and the District of Columbia joined the case.

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