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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Concerns that Texas abortion ruling will upend FDA authority are ‘totally alarmist’: Sen. CassidyThe Louisiana Republican said the Supreme Court ruling last year that overturned Roe v. Wade 'was the correct decision' in an exclusive interview on NBC News' 'Meet the Press.'
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Bill Cassidy dismisses Democrats’ concerns over FDA authority after abortion pill rulingSen. Bill Cassidy on Sunday described fears by Democrats that a court ruling against the abortion pill mifepristone could uproot the Food and Drug Administration’s approval of other drugs as vastly exaggerated.
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New York Stockpiling Abortion Pill as Legal Fight Heads for Supreme CourtThe nationwide rallies come after the U.S. Supreme Court intervened Friday to delay rule changes that would have limited the way the abortion drug mifepristone could be used and dispensed, to give itself more time to review the matter more thoroughly.
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