Biotech Execs Weigh In on Mifepristone Ruling

April 12, 2023

In an amicus brief filed by a group of organizations, industry groups, and several biotech executives, writers argue that last week’s ruling overturning the US Food and Drug Administration’s (FDA’s) approval of mifepristone, a key component of the abortion pill, will “upend” the agency’s approval process for new drugs. This change, the authors warn, would harm patients and cut back research investments into drug development, as any drug may be pulled from market based on a judge’s whims.

According to Nicole DeFeudis, “Mifepristone has been marketed for 23 years and used by millions of women. More than half of women who choose to end their pregnancies rely on the medication abortion drug, according to recently filed court documents. However, execs argued in the amicus brief on Tuesday that the Texas court replaced the FDA’s “gold-standard benefit-risk analysis and expert judgment” with “anecdotes and conjecture.””

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