Abortion-pill rulings could break the FDA, drug companies say

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Pharmaceutical companies have mobilized against a pair of lower-court rulings restricting access to abortion pills that they contend go far beyond issues of reproductive health and pose a threat to the regulatory foundations of the U.S. drug industry.

— are harshly critical of rulings this month by a U.S. District Court judge in Texas and a three-judge panel of the 5th Circuit Court of Appeals.on April 7 that the Food and Drug Administration should not have approved the abortion pill mifepristone in 2000, deciding that the FDA rushed the process and that the pill was unsafe.

“While we may be talking about mifepristone today, we must understand that political motives could similarly attack many innovative and lifesaving biotherapeutics such as genetic medicines, cell therapies and even today’s major advancements in mRNA vaccine technology,” Reid Huber, a partner at Third Rock Ventures, a health care venture capital firm with offices in Boston and San Francisco, said in an email.

to the court that drug companies and investors rely heavily on the FDA to guide how they bring drugs to market. It called Kacsmaryk’s ruling that overturned the FDA’s 2000 approval of mifepristone “an unprecedented assault on FDA’s approval decisions.”The dire warnings illustrate the degree to which the U.S. health care industry is dependent on federal rules for its survival.

GenBioPro, a generic producer of mifepristone that won approval in 2019, said in a friend-of-the-court brief the impact on its operations would be catastrophic. It said that would be forced to cease sale of mifepristone unless the 5th District ruling is stayed. The company said its pills account for about two thirds of the 500,000 annual medication abortions in the United States.

 

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Uh yeah, breaking the government is the overarching goal of these billionaire conservative extremists. We beg you to connect the dots for the public more directly.

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