Should the FDA approve Paxlovid before the emergencies end?
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Click here to read the Cover Story, "Experts fear impact of US plan to end COVID-19 emergencies."
[Editor’s note: On March 16, an FDA advisory committee recommended that the FDA approve Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19.]
The public health and national emergencies related to the COVID-19 pandemic are set to end on May 11.
Although this date allows providers and patients alike to make necessary adjustments, many patients will still feel the effects when funding ends and Medicare’s coverage of important preventatives and treatments — such as Paxlovid — stops.
We asked David Boulware, MD, MPH, infectious disease physician-scientist and professor at the University of Minnesota Medical School, if the FDA should approve Paxlovid before the emergency declarations end.
I think that the FDA will finish their approval process for Paxlovid in April, before the end of the public health emergency. One fundamental question is why is the approval process taking so long? What is going to change with the data between now and when Paxlovid is approved?
The typical timeline for FDA biologics license application approval of a new compound is between 1 to 2 years after the application is filled. For infectious diseases products, the average is 1.2 years from initial filling to approval. “Fast tracking” is less than 6 months.
One might question how withholding medicines for around 1.2 years on average benefits Americans, but this is the system. If Congress wanted faster approvals for American citizens, they could provide more funding to the FDA, lessen regulations or perhaps have a two-tiered initial/final approval structure.
The amount of regulatory red tape that wraps up clinical trials is astonishing — increasing costs and creating a regulatory industrial complex where someone has to review all of the data generated. When necessary, the U.S. government bureaucracy can move faster when there is leadership on a particular issue.
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