Pharma and FDA Wary of Dueling Texas and Washington Abortion Pill Rulings

Last week’s ruling in a US federal court that struck down the decades-old approval of mifepristone, a key drug in the abortion pill, has the US Food and Drug Administration (FDA) and the entire pharma industry on edge. The ruling, according to some legal experts, would undermine the agency’s ability to independently approve drugs based on scientific evidence. Another ruling last Friday ordered the FDA to continue providing the drug to 17 states.

According to Greer Donley, associate professor of law at the University of Pittsburgh, “The only way for the FDA to comply with both orders is to allow the drug to become unapproved … but then issue a guidance document or something similar saying ‘We are not going to enforce the Food, Drug and Cosmetic Act against the manufacturers and distributors of mifepristone, so long as those manufacturers and distributors follow these carefully articulated rule.”

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(Source: Politico, April 10^th, 2023)