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Hostage Crisis Ends On Day 73—American Patients Now Have Access to One Antiviral Pill

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Jeffrey A. Singer Earlier this week I wrote about foot‐​dragging by the Food and Drug Administration regarding approval of two highly effective antiviral pills. With the omicron variant of COVID-19 rapidly spreading throughout the population, infecting both vaccinated and unvaccinated, these pills becomes even more important. Merck applied to the FDA for Emergency Use Authorization (EUA) ...

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Jeffrey A. Singer

Earlier this week I wrote about foot‐​dragging by the Food and Drug Administration regarding approval of two highly effective antiviral pills. With the omicron variant of COVID-19 rapidly spreading throughout the population, infecting both vaccinated and unvaccinated, these pills becomes even more important.

Merck applied to the FDA for Emergency Use Authorization (EUA) of its antiviral molnupiravir on October 11, 2021—73 days ago. The drug was approved for emergency use in the U.K. on November 4. It is 30 percent effective in preventing COVID infections (including the omicron variant) from progressing to hospitalization, and no patient receiving molnupiravir died from infection. On November 30 an FDA advisory committee recommended its approval. As of this writing the FDA has not acted on the advice of the committee.

On November 16 Pfizer sought an EUA for its drug Paxlovid. The drug is 89 percent effective in stopping infections from progressing to hospitalization. Nobody receiving Paxlovid in clinical trials died from COVID. As of yesterday, the FDA had not even called a meeting of its advisory committee to look at the trial data.

Today the FDA finally acted. It granted Emergency Use Authorization to Pfizer’s Paxlovid without even waiting for an opinion from its advisory committee. The FDA director of its Center for Drug Evaluation and Research, Patrizia Cavazzoni, MD, stated:

This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.

Still no word from the FDA on molnupiravir. But at least American patients now have access to one lifesaving pill. It took 73 days for that to happen. During those 73 days 87,569 Americans have died—1,811 died yesterday (source: worldometer).

As Michael Cannon and I write in Drug Reformation: End Government’s Power To Require Prescriptions, one intermediate reform that would partly mitigate the government’s infringement on our right to self‐​medicate would be for Congress to allow adult consumers to purchase drugs and devices that may not be FDA‐​approved, but are approved by a list of designated countries’ drug approval agencies. Drugs approved by FDA‐​equivalent agencies in the European Union, U.K., Switzerland, Israel, and Japan immediately come to mind. Labels would inform consumers that the drugs or devices are not FDA‐​approved but are approved by a particular country’s agency. If such a law were in effect today, many Americans would have had access to Merck’s molnupiravir since early November. How many lives might have been saved?

Such a proposal, called drug approval “reciprocity” by some, was introduced in the U.S. Senate in imperfect form in 2015. Unfortunately, it did not advance to a vote. A modified version that limits reciprocity to public health emergencies was introduced on March 2020.

Hopefully, as America’s patients and doctors grow increasingly impatient with sclerotic regulatory agencies impeding a quick response to our public health emergency, reciprocal approval will get renewed attention.

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