FDA is Back to Undermining Coronavirus Fight
In today's article, I looked at the real reason why we have a hand sanitizer shortage, and some of it goes back to FDA insanity which insists on regulating it as a drug.
As part of President Trump’s moves to cut the red tape, the FDA announced that it won’t be cracking down on pharmacies that make their own hand sanitizer. Or as the official government release states, “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.”
The FDA's permissiveness for making hand sanitizer is limited to "State-licensed pharmacies or Federal facilities." And it's not providing permission, per se, but announcing that it "does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency."
The FDA issued its final hand sanitizer rule just last year. This rule finalized the FDA's "tentative final monograph" on hand sanitizer from 1994.
That’s 25 years from "tentative final monograph" to the final rule for alcohol and water in gel form.
According to Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, the final rule, "also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers."
After decades of this madness, the FDA would like still more data to determine that alcohol is a safe and effective means of sterilizing human hands.
The FDA slowed down the coronavirus response by sabotaging CDC efforts and those of private labs running tests for the virus. Now it's fighting against crash programs to get answers.
The news came after a report in the Wall Street Journal said the White House had considered issuing an executive order greatly expanding the use of “investigational drugs” against the virus.
But the FDA objected, warning that that could pose unnecessary risks to patients, according to a senior government official, the paper reported.
No doubt it will pose risks. Then again the FDA has signed off on drugs that turned out to have horrible side effects many years later. If this is truly a devastating plague that will kill millions, then it makes sense. If it's not, then why did we shut down our entire economy?
We're not going to really know what the side effects look like until years and large number of patients have taken the drugs. And the FDA might have more credibility if its fixation on the rules hadn't slowed down the response to the coronavirus from the very beginning.
President Trump should follow his instincts and issue that executive order.