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Pharmaceutical companies denounce US court order against abortion pill

More than 250 business executives pharmaceutical and biotech denounced this Monday in an open letter the recent order of a federal judge of USA to undo national approval of the abortion pill mifespristone.

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Last Friday, a judge from Texas postulated by former President Donald Trump (2017-2021) ordered the revocation of the authorization that Food and Drug Administration (FDA) gave mifepristone in 2000 and argued that he did not follow the proper procedure.

The group of executives, led by the CEO of Pfizer, Albert Bourlapointed out that the magistrate’s decision Matthew Kacsmaryk “undermines” the authority of the FDA on drug approval and “It creates uncertainty for the biopharmaceutical industry.”

“Add uncertainty Adding to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives to invest, jeopardizing the innovation that characterizes our industry.”they pointed out.

The signatories emphasize that the judge, whom they make ugly “not having scientific training”, he ignored “decades of scientific evidence and legal precedent”, and defend as “proven” that the mifepristone it’s more “I’m sure he Tylenol (Acetaminophen), almost all antibiotics and insulin”.

Considering the order a “lawful interference” on the power of the federal regulator to “protect public interests”the pharmaceutical sector warned that the “judicial activism does not stop here” and that any medication could be subject to withdrawal.

They recognized that the drug development process, its approval, and its follow-up “Is not perfect”but noted that the framework of the FDA has given rise to mechanisms that allow the withdrawal of drugs from the market if they do not meet their expected safety and efficacy profile.

The judge’s ruling, whose entry into force is scheduled for this Friday after a week for appeals, has already been appealed by the Governmentwhich has also indicated that it will do everything possible to keep the drug available, including the possibility that the FDA ignore the order.

Source: Elcomercio

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