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EU: Pharmaceutical companies denounce court order against abortion pills

  • April 10, 2023
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More than 250 business leaders pharmaceutical and biotechnological condemned this Monday in an open letter the recent order of a United States federal judge to annul approval of

EU: Pharmaceutical companies denounce court order against abortion pills

More than 250 business leaders pharmaceutical and biotechnological condemned this Monday in an open letter the recent order of a United States federal judge to annul approval of the abortion pill mifepristone at the national level.

Last Friday a texas judge As postulated by former President Donald Trump, he ordered the revocation of a Food and Drug Administration (FDA) approval for mifepristone in 2000 and claimed he did not follow due process.

An executive team led by Pfizer CEO Albert Burla indicated that Justice Magistrate Matthew Kaczmarik’s decision “undermines” the credibility of the FDA on drug approval and “creates uncertainty for the biopharmaceutical industry.”

Photo: Reuters

“Adding regulatory uncertainty to the already risky job of discovering and developing new drugs is likely to lead to reduce investment incentives, endangering the innovation that characterizes our industry,” they said.

The signatories emphasize that the judge they make is uglyhave no scientific background“, ignores “decades of scientific evidence and legal precedent” and defends as “proven” that mifepristone is “safer than tylenol (acetaminophen), almost all antibiotics and insulin”.

Calling the order “judicial interference” with the federal regulator’s “public interest” authority, the pharmaceutical industry warned that “litigation activity doesn’t stop there” and that any drug could be subject to distraction.

They acknowledged that the drug development, approval, and monitoring process is “not perfect,” but noted that the FDA’s structure has led to the creation of mechanisms that allow drugs to be withdrawn from the market if they do not meet their intended safety profile. and efficiency.

The judge’s decision, due to take effect this Friday after a week of appeals, has already been challenged by the government, which has also indicated it will do everything possible to keep the drug available, including the possibility that the FDA will ignore the order.

(EFE)

Source: Aristegui Noticias

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