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 those limits are not supported by evidence.
He lawsuit, led by the state of Washington and Oregon, was filed Thursday in federal court in Yakima, Wash., and aims to expand access to mifepristone by allowing any doctor or pharmacy to prescribe and dispense it, like most the drugs. Currently, physicians 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 is underway in Texas.
Mifepristone, in combination with the drug misoprostol, was approved by the FDA in 2000 for medical abortion in the first 10 weeks of pregnancy. Medical abortion accounts for more than half of all abortions in the United States.
Medical abortion has drawn increasing attention since the US Supreme Court last year overturned its landmark Roe v. Wade of 1973 that had legalized abortion throughout the country. The decision allowed more than a dozen Republican-led states to adopt 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 sweeping Supreme Court decision that struck down Roe v. Wade, the FDA is now exposing doctors, pharmacists, and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.»
The lawsuit said that mifepristone is «safer than many other common FDA-regulated drugs, such as Viagra and Tylenol.»
The other states that are part of the lawsuit are Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.
An FDA spokesman declined to comment on the lawsuit.
Anti-abortion activists have asked a federal judge in Texas to order a nationwide withdrawal of mifepristone from the market, arguing that the FDA used an inadequate process to approve the drug and failed to adequately consider its safety for minors.
In addition to challenging FDA restrictions on how the drug is made available, Democratic-led states are asking the court to rule that the agency’s approval of mifepristone is legal and valid, potentially creating a conflict with any order in the Texas case that would require federal appeals courts to intervene.
The FDA’s special restrictions on mifepristone are imposed under a safety program intended to minimize the risk of potentially dangerous drugs. The agency has relaxed those restrictions multiple times since they were first imposed, most recently in January, when it allowed certified retail pharmacies to dispense mifepristone.
After last year’s Supreme Court ruling, President Joe Biden ordered federal agencies to expand access to medical abortion. Vice President Kamala Harris defended mifepristone on Friday after meeting with reproductive rights groups at the White House, calling attacks on it an attempt to attack the fundamental rights of Americans.