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Twelve Democratic-led states have sued the Food and Drug Administration to challenge certain federal restrictions on the distribution of the abortion pill mifepristone, saying the restrictions are not supported by evidence.
The lawsuit, led by the states of Washington and Oregon, was filed on Thursday in federal court in Yakima, Washington and aims to expand access to mifepristone by allowing it to be prescribed and dispensed by a doctor or pharmacy, like most drugs. Currently, doctors who prescribe mifepristone, and pharmacies that dispense it, must obtain special certification.
Meanwhile, a separate lawsuit by anti-abortion activists seeking to end access to the drug continues in Texas.
Mifepristone, in combination with the drug misoprostol, was approved in 2000 by the FDA for medical abortion in the first 10 weeks of pregnancy. Medication abortions account for more than half of all US abortions.
Abortion treatment has drawn increasing attention since the US Supreme Court last year overturned its landmark 1973 Roe v. Wade managed to legalize abortion nationwide. The decision enabled more than a dozen Republican-led states to enact new abortion bans.
“The federal government has known for years that mifepristone is safe and effective,” Washington state Attorney General Bob Ferguson said Friday in a statement announcing the lawsuit. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risks. FDA’s enormous restrictions on this important drug are not based on medical science.”
The lawsuit says mifepristone is “safer than other generic drugs regulated by the FDA, such as Viagra and Tylenol.”
Other states that are part of the lawsuit are Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.
An FDA spokeswoman declined to comment on the lawsuit.
Anti-abortion activists are asking a federal judge in Texas to order mifepristone off the market nationwide, arguing that the FDA used an improper process to approve the drug and did not consider its safety for minors.
In addition to challenging the FDA’s restrictions on how the drug is available, Democratic-led states are asking the court to decide whether the agency’s approval of mifepristone is legal and valid, potentially conflicting with any order in the Texas case that will require a federal appeals court to consider.
The FDA’s special restrictions on mifepristone are implemented under the safety program to reduce the risk of harmful drugs. The agency has lifted the ban several times since it took effect, most recently in January when it allowed certified retail pharmacies to dispense mifepristone.
After last year’s Supreme Court ruling, President Joe Biden directed federal agencies to expand access to medication abortions. Vice President Kamala Harris defended mifepristone on Friday after meeting with reproductive rights groups at the White House, calling the attack an attempt to attack basic American rights.