We Have New Covid Drugs- FDA Needs to Get Out of the Way. Drs. Singer and Bloom in the NY Daily News

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Two newly-approved antiviral drugs against COVID are now available to people who need them. But the FDA is getting in the way with unwise and counterproductive requirements. Drs. Jeffrey Singer and Josh Bloom in the New York Daily News

The Food and Drug Administration recently granted Emergency Use Authorization (EUA) to Paxlovid and molnupiravir, two lifesaving, direct-acting antiviral drugs that are effective in preventing both hospitalization and death of people who have contracted COVID-19. They are effective against all variants so far, including omicron, which is capable of infecting people regardless of whether they are non-vaccinated or fully vaccinated.

Unfortunately, two requirements that the agency put in place in authorizing these drugs will all but guarantee that most people who need them will not be able to get them in time. And time is of the essence since the drugs are only effective when taken within five days of initial symptoms.

First, the FDA lists numerous health criteria as prerequisites for a prescription, repeating the same mistake the agency made when it first approved the Pfizer and Moderna vaccines. While health considerations may seem reasonable, perhaps even wise, the logistics of applying existing health risks as a condition for dispensing the drug make the process cumbersome and unworkable.

The list of conditions is itself arbitrary and vague. It includes people with “heart disease,” which can be minor or serious; current or former smokers, regardless of how much they smoke or whether they quit; and dementia or other neurological conditions. The list is so broad and poorly defined as to make it medically arbitrary and impractical. All of this assumes a patient can get in to see a doctor.

#Reprinted with permission of the New York Daily News. The entire op-ed can be found here.