The FDA and Coronavirus

The failure of the FDA/CDC to adequately prepare for coronavirus, despite weeks of advance notice from China is one of the most shocking and serious examples of government failure that I have seen in my lifetime. After being prevented from doing so, private laboratories are now allowed to offer coronavirus tests and Bill and Melinda Gates’s Foundation is working on an at home swab and test.

But what happens when people get sick? What drugs will patients be allowed to try given that there is no standard treatment available? One experimental antiviral, Remdesivir, was given to the first US patient who was on a downward spiral but seemed to recover after receiving the drug. Gilead, the manufacturer says:

Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. At the request of treating physicians, and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options.

If Gilead is willing to supply, should patients have a right to try? This seems like a good case for the dual tracking approach proposed by Bartley Madden–let patients try unapproved drugs but collect all information in a public database for analysis. Clinical trials for Remdesivir and other potential drugs are currently underway in China.

Chloroquine, might also be useful against Covid-19. Chloroquine was approved long ago to treat malaria and physicians are allowed to prescribe old drugs for new uses. New uses for old drugs are discovered all the time and they do not have to go through long and costly FDA approval procedures before being prescribed for the new uses. Since chloroquine has never been tested for efficacy against coronovirus, allowing physicians to prescribe it is similar to allowing physicians to prescribe an unapproved drug like Remdesivir. The difference in how new drugs and old drugs for new uses are treated is something of a regulatory anomaly but a fortunate one as I argue in my paper on off-label prescribing.

I suspect that my arguments for less FDA regulation will be relatively well received during the current climate of fear. Bear in mind, however, that for the patient who is dying it’s always an emergency.

Hat tip: Balaji Srinivasan, who really would make a great FDA commissioner.


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