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FDA Finally Grants Patients Access to Molnupiravir

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Jeffrey A. Singer Yesterday the Food and Drug Administration gave emergency use authorization (EUA) to the antiviral drug Paxlovid, more than a month after its manufacturer, Pfizer, submitted its application. This pill, if taken within the first few days of a COVID-19 infection, has been found to be 89 percent effective in preventing progression of the disease ...

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Jeffrey A. Singer

Yesterday the Food and Drug Administration gave emergency use authorization (EUA) to the antiviral drug Paxlovid, more than a month after its manufacturer, Pfizer, submitted its application. This pill, if taken within the first few days of a COVID-19 infection, has been found to be 89 percent effective in preventing progression of the disease to hospitalization. Clinical trials found no patients taking Paxlovid died from the virus.

Seventy‐​four days ago, Merck applied for an EUA for its antiviral molnupiravir. If taken in the first few days of COVID infection it is 30 percent effective in preventing hospitalization. As in the Paxlovid clinical trials, none of the patients on molnupiravir died of the virus. An FDA advisory panel recommended molnupiravir be approved on November 30, yet the FDA failed to act. Until today. This morning the FDA finally gave America’s patients access to the second of two antiviral drugs that snuff out COVID-19 infections including those from the omicron variant.

This is good news, but as I have mentioned before, U.K. regulators approved molnupiravir for British residents nearly two months ago. Had Congress enacted reciprocity legislation, wherein American patients can purchase drugs approved by regulators from other advanced countries, patients would have had access to molnupiravir since early November. How many lives could have been saved?

Normally the FDA makes a decision within a few days of receiving an opinion from its advisory council. But it took more than 3 weeks to decide this time. Interestingly, the FDA didn’t even seek the counsel of its advisory panel before granting the EUA to the more effective Paxlovid yesterday. Not that I’m complaining. But when regulators wait so long after an advisory panel recommended molnupiravir before granting the EUA, yet they don’t even seek the opinion of the advisory panel when granting the EUA for Paxlovid, one can’t help but wonder how much of the approval process really entails “following the science.”

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