TUESDAY, April 11, 2023 (HealthDay News) – The U.S. Justice Department on Monday appealed a Texas court ruling that invalidates the U.S. Food and Drug Administration's approval in 2020 of mifepristone, the first of two drugs taken during a medical abortion.
The ruling by U.S. District Judge Matthew Kacsmaryk in Texas is “extraordinary and unprecedented,” the Justice Department said in its appeal. “If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity."
Pharmaceutical executives have also weighed in on the ruling, signing a letter on Monday warning about the impact if the Texas order was to take effect.
“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” stated the letter, according to the Associated Press.
While Kacsmaryk’s ruling said the order would not take effect for seven days, within 20 minutes of the order a federal judge in Washington state issued a ruling directing the FDA to make no changes that would restrict access to the drug in 17 states where Democrats had sued, the AP reported. The Justice Department has asked for clarification on that ruling.
The Texas lawsuit was filed by the Alliance Defending Freedom, the same group that filed a suit leading to the overturning of Roe v. Wade by the U.S. Supreme Court last June. It alleges that the FDA should not have approved mifepristone because it did not adequately review its safety risks.
Mifepristone has been used in the United States for more than 20 years. It is typically used along with misoprostol. It’s not clear whether, if it’s banned, providers will switch to prescribing just misoprostol for medication abortions or perform only surgical abortions where they are legal.
“We don’t know exactly what will happen,” Jennifer Dalven, director of the American Civil Liberties Union’s Reproductive Freedom Project, told the AP. “What we do know is that there will be significant confusion and chaos as providers try to provide the best care they possibly can for their patients.”
Abortions are banned or unavailable in 14 states, while 16 states have laws directed toward abortion medications, the AP reported.
The nonprofit KFF has more on the availability and use of medication abortion.
SOURCE: Associated Press
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