Pfizer COVID pill missed step in FDA regulatory approval

[Joe]

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The FDA authorized Pfizer Inc.'s pill to treat Covid-19 without first getting input from a panel of clinical advisers, a move public health professionals say could further undermine trust in an agency already facing scrutiny over its rapid decision-making during the pandemic.

Policy analysts say that while the Food and Drug Administration isn’t required to convene an advisory committee meeting before it makes decisions on new products, these public discussions have helped educate Americans on the regulatory process throughout the pandemic. Skipping this step for the Pfizer pill could affect the public’s level of confidence in the potentially lifesaving Covid-19 treatment and in the agency at large.

“There is quite a bit of urgency right now that many of us are feeling about the way that omicron is moving so rapidly into dominance,” Lynn Goldman, dean of the George Washington University’s Milken Institute School of Public Health, said. The FDA may be trying “to move these pills on the market as soon as possible,” but there is “always a cost when you do that in terms of transparency.”

The FDA’s Wednesday emergency use authorization makes Pfizer’s Paxlovid thefirst at-home medication cleared for Covid-19. The drug is intended to help prevent hospitalization and death among higher-risk people who test positive for the virus.

Officials familiar with the plans say U.S. regulators could authorize a second pill for Covid-19, Merck & Co.’s molnupiravir, as soon as Wednesday.

The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) met late last month to consider safety and efficacy data from trials with Merck’s drug. The committee narrowly recommended the pill in a 13-10 vote, with some members of the panel citing safety concer

 

[Oerdin]

It is just a protease inhibitor which functionally mimics Ivermectin. That is literally what Pfizer did. They wanted a compound which did exactly what ivermectin did, bound the same receptor site Ivermectin, but which was different enough in structure that they could patient it. I would like to see head to head trials with this and Ivermectin because I doubt it work better and it just costs a shit ton more.

There is a reason people call this pfizer-mectin.