The states are asking the court to find the FDA restrictions unlawful and unenforceable. (Photo: U.S. Food and Drug Administration)
Nevada joined a multistate federal lawsuit against the Food & Drug Administration over its handling of one of the drugs used in abortion pills, Democratic Attorney General Aaron Ford announced Friday.
The lawsuit, filed in U.S. District Court for the Eastern District of Washington, claims the FDA’s current restrictions on prescribing and dispensing the drug mifepristone are excessively burdensome and contradict the drug’s clear history of being safe.
The states are asking the court to find the federal restrictions unlawful and unenforceable.
According to the lawsuit, only 60 of the more than 20,000 drugs approved by the FDA are subject to a set of restrictions known as “Risk Evaluation & Mitigation Strategies.” REMS is designed to safeguard against inherently dangerous drugs, such as opioids or high-dose sedatives.
Mifepristone, the lawsuit argues, is associated with fewer serious side effects than common drugs like Tylenol and Viagra. Mifepristone has been associated with zero deaths, according to FDA data.
Currently, before receiving mifepristone, patients and providers must sign a ‘patient agreement form’ that certifies the patient has decided to use the drug to end their pregnancy. That documentation stays in the patient’s medical records.
The lawsuit argues that, in addition to being excessively burdensome and scientifically unjustified, such restrictions open providers and patients to potential violence, harassment, abuse or legal liability, particularly in states with extreme anti-abortion rights laws.
“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,” said Ford in a statement. “The FDA’s regulations regarding mifepristone do not protect those seeking abortions, but they do make reproductive health care harder to access.”
Medication abortions accounted for 53% of all facility-based abortions in the United States, according to the Guttmacher Institute. In Washington State, that percentage is closer to 60%, according to the lawsuit.
FDA-approved medication abortions involve a dose of mifepristone, which blocks the effect of progesterone (a hormone needed to maintain a pregnancy), followed by a second drug, misoprostol, which causes uterine contractions. They are prescribed to women in early stages of pregnancy — typically within the first nine weeks.
The drugs are also used for treatment of miscarriages.
The federal lawsuit is led by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum. Nevada, along with Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, New Mexico, Rhode Island and Vermont, have also joined the lawsuit. All the attorneys general are Democrats.
Earlier this month, AG Ford announced he’d signed Nevada onto a multi-state coalition in support of medication abortion at CVS and Walgreens. The pharmacies announced their decision to carry mifepristone and misoprostol in January, following a regulation change by the FDA that allowed them to do so, but received immediate pushback from some Republican states.
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