Bloomberg Law: December 22, 2021
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 the first 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 concerns—including for pregnant people and the potential for the treatment to spur genetic mutations.
Clinical trial data on Pfizer’s pill showed an 88% reduction in hospitalization for high-risk patients within five days of symptoms starting. Approximately 0.8% of those who received Paxlovid were hospitalized or died during 28 days of follow-up, compared with 6% of patients who received a placebo. The Merck drug reduced the relative risk of hospitalization or death among adults with mild to moderate disease by 30%.
Meetings of expert panels, while not required, have become a common practice in the FDA’s authorization process amid the ever-changing conditions of the pandemic.
“The FDA has smart people—but as smart people they also realize that they can’t always think of everything,” said Peter Weina, a current AMDAC member and an expert in infectious diseases. “That’s when they ask for outside opinions.”
Advisory committee meetings are most common “when something is controversial” or when “it’s not absolutely clear that it should be rejected, and it’s not absolutely clear that it should be approved or authorized,” said Diana Zuckerman, founder and president of the National Center for Health Research.
“Sometimes, it seems that the FDA has advisory committee meetings when they really want to reject something that they want other people to tell them to do it,” she added. “And then sometimes, it’s because they really want to approve or authorize something and they can pick their advisory committee to be the kind of people who are going to give them the answer that they want.”
While the FDA convened a meeting for the Merck drug, the Pfizer pill’s higher efficacy rate and the fact that the two treatments target Covid-19 differently may have influenced the FDA’s decision to authorize Paxlovid without first hearing from outside experts, analysts say.
Analysts say that advisers could have discussed the drug in a meeting similar to the one held for Merck’s pill to ensure the highest level of transparency possible, despite the vast data in favor of the Pfizer pill’s safety and effectiveness.
“Given all the politicization of anything related to Covid, it’s in the public’s best interest to have as much information as possible publicly available,” Zuckerman said. “Having a public meeting where people can ask questions, and people have to answer those questions in front of reporters and other media people, is really the better way to go.”
The FDA released some research findings on the Pfizer pill Wednesday, but “it is still true that the FDA didn’t make the data available at a public FDA meeting where independent scientists could scrutinize the data and ask questions about the implications of the research findings,” she said.
Pfizer has made the clinical data from the Paxlovid trial publicly available online, and the FDA released fact sheets Wednesday to give health-care providers and patients detailed information on dosing instructions, potential side effects, drug interactions, and information on who is eligible to receive the drug.
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