Monday, October 11, 2021

FDA overrules staff, will stop blocking the use of drug that could dramatically reduce heart risk in patients moving out of hospital

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The chief federal drug regulatory official on Wednesday overruled the drug agency’s own employees and ordered them to ease the approvals of a drug that could lower the risk of heart attacks and stroke and make it safer to move patients out of hospitals.

The decision by an internal advisory panel at the Food and Drug Administration led to an unusually public blowout between the agency and the staff because it also recommended that the agency increase the maximum doses of the drug’s pills, citing the approval of an application to do so by Pfizer.

Even as drugmaker Pfizer and its industry allies claimed the panel’s recommendations would open the door to dangerous drugs, the company promised it would fully comply with the FDA’s new ruling.

The anger over the Pfizer decision was largely sparked by the panel’s recommendation, which was spurred by substantial conflicting studies on the heart risks of the two proposed drugs. The drug boards, which monitor the safety of the drug regulators, are set up to reflect those conflicting studies, but recently that consensus has begun to break down and the panelists have taken on an increasingly leftist bent, pushing through regulations they believe would benefit activists but hurt businesses.

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