Pandemic makes case for lessening FDA obstacles

Give federal regulators credit for recognizing that the coronavirus pandemic is no time for business as usual. The Food and Drug Administration, in particular, seems to have surgically removed some of the red tape from its process.

On Friday, the FDA announced it will be permitting emergency use of a new drug, remdesivir, which has shown promise in shortening the time COVID-19 patients need to recover from the potentially deadly disease.

Remdesivir, developed by Gilead Sciences, was tested in a study involving 1,063 patients. It shortened the time needed to recover from the coronavirus by an average of 31 percent. On average, COVID-19 sufferers treated with remdesivir were able to leave the hospital in 11 days. Patients in the control group, which did not receive the drug, required an average of 15 days.

Gilead, incidentally, planned to donate its stock of remdesivir and put production in high gear to make more available.

One need not be a scientist to recognize the potential value of remdesivir — or to wonder how many lives it might have saved if it had been available sooner.

That has been a perennial complaint about the FDA: the time needed to gain federal approval for use of new drugs. The tragic consequences of the COVID-19 pandemic ought to prompt both the FDA and Congress to take a look at that question.

It also should spur all concerned to eliminate obstacles in the way of developing, producing and distributing a vaccine against COVID-19.

It needs to be remembered, after all, that neither viruses nor bacteria have any respect at all for a bureaucracy.


Today's breaking news and more in your inbox

I'm interested in (please check all that apply)


Starting at $4.62/week.

Subscribe Today