Experts see the lawsuit as an attempt to produce a contrary ruling from a Trump-appointed Texas judge, who many predict will order the FDA to remove mifepristone from the market.
drug safety program designed to regulate dangerous or addictive drugs, such as fentanyl and other opioids, certain risky cancer drugs and high dose sedatives used for patients with psychosis. The FDA has imposed REMS on only 60 medications out of the more than 20,000 prescription drugs approved for use in the U.S.
“FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” according to the AGs’ complaint. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the plaintiff states and their healthcare providers to dispense.
The states argue that the REMS requirement that providers register with the drug manufacturer could compromise their privacy and safety, result in them being targeted by. Abortion opponents made 182 death threats against abortion providers in 2021 alone. The lawsuit also objects to the FDA requirement that patients must fill out a patient agreement form, which must be included in their medical records and, and for women from states banning abortion, can be viewed by providers in their home states.
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