Friday’s dueling decisions over a key abortion drug thrust the Food and Drug Administration into an unprecedented legal bind, imperiling its authority to approve and regulate medications, legal scholars said.
In Washington state, a federal judge ruled Friday that mifepristone is safe and effective, ordering the FDA to preserve access to the pill in the 17 states and D.C. that sued to protect medication abortion. But in Texas, another federal judge sided with antiabortion groups to block the agency’s approval of mifepristone, a decision that won’t go into effect for seven days, to give the federal government a chance to appeal.
Ameet Sarpatwari, an expert on pharmaceutical policy and law at Harvard Medical School, said Kacsmaryk’s ruling is likely to encourage a spate of additional challenges. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” he said in a statement.the late 1980s in France. Used along with another drug, misoprostol, it essentially causes a miscarriage. Even before the Supreme Court overturnedof legal abortions in the country.
and provide a “meaningful therapeutic benefit” over existing treatments. Alliance Defending Freedom insisted that pregnancy isn’t an illness. The government countered that the FDA did not use an “accelerated” approval and its own regulations say the process could be used for a serious or life-threatening “condition.”
The claims made by Alliance Defending Freedom also received pushback from abortion providers, Biden officials and some legal experts. Leading medical organizations — such as the American Medical Association and the American College of Obstetricians and Gynecologists — sayEven before the dueling opinions Friday, experts had gamed out different strategies for the FDA.
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