In late March of 2020, the Food and Drug Administration gave Emergency Use Authorization (EUA) for the malaria drug hydroxychloroquine as a treatment for COVID-19. The drug is already used off-label for diseases like arthritis and given how it behaves with human biology, it is plausible it might work on some with COVID-19. A peer-reviewed study found just that - but it was only epidemiology, and that is not how drug approval ever happens, any more than epidemiology alone should be how regulations happen at EPA or any policy-making group. 

Other correlation studies found it did not work, some found it increased heart issues enough so that its risks outweighed benefits. A few weeks later FDA waffled and with just as little evidence as they made in approving it they revoked it. They were more guided by Twitter activity than science.

We clearly need clinical trials. But with the American economy in freefall due to forced business closures, what no one needs even less than the FDA that makes decisions based on correlation is the FDA of February of 2020 - which treated any new hand sanitizer or epi-pen competitor like a brand new medical device and wanted companies to spend a decades and hundreds of millions before going to market.

Emergency Use Authorization is a good thing but how can we insure that a government body which is composed of 95 percent career bureaucrats not create new roadblocks to claim they are protecting us, while also not reacting politically and handing out EUAs recklessly? This is important, given the hype around Russia claiming their Sputnik V vaccine works, when it would only be a sloppy Phase I result for any American company. We don't want FDA doing the same thing. 

A new opinion piece in JAMA hopes to outline ways that FDA can gain back some public trust; and though we can talk about recent gaffes as catalysts, trust was lacking long before March of this year. They let $35 billion in supplement revenue get sold to unsuspecting people annually while they have created blockades that have increased the time and cost for actual medicine approval by 100 percent in the last 20 years. 

Hydroxychloroquine was hardly the first misfire by FDA this year and continuing to harp on it is not constructive. What FDA needs more than talking about the past are standards for things that require regulatory approval now. People ran out of Purell because prior to March the market was not big enough to warrant a bunch of companies jumping in to compete when the regulatory burden was high. Instead of creating a safety standard and telling companies they will go to jail if they don't meet it, FDA treated hand sanitizer like a new cancer drug. So then the public were mixing rubbing alcohol and aloe gel in their homes when they weren't buying bootleg products from Amazon. More regulations won't fix that, a standard any manufacturer can meet and sell is the solution to a lot of things FDA slows down. Less regulation, more choices, the same safety.

Some of the recommendations make obvious sense. If you have ever read public comments on science policy efforts at FDA, USDA, or EPA, you know the public absolutely should not vote on these things. Any food that 'contains DNA' would be banned if the public voted. But the EUA process can be a little more transparent. Leaders are given authority to do these jobs to mitigate even more bureaucracy creeping in but they have Advisory Committees for a reason. A lot of them will also be appointees, and therefore may have agendas, but just like with comment periods they may provide some insight as well. Would other epidemiologists have stopped hydroxychloroquine from getting an off-label EUA? There is no reason to believe so, since epidemiologists peer-reviewed it, and epidemiologists peer-review a thousand Miracle Vegetable and Scary Chemical claims per month without being critical, but at least that would be on the record.

One thing is already being done but could be broadened for a COVID-19 vaccine; a Phase IV aftermarket reporting mechanism. Now, lawyers are waiting to sue everyone over everything, and a COVID-19 vaccine will be no different when they see dollar signs in the jury's eyes, but vaccines currently must show actual harm - people cannot just get on the stand and claim they were harmed, like with baby powder or weedkillers. So that could be a protection for science.

This all sounds like common sense, and it is, but that is one thing that was lacking in the regulatory efforts of FDA and CDC over the last decade. Their missions instead increasingly became manufacturing new problems (e.g. "prediabetes") so they could claim they would fix them. COVID-19 has meant resets for a lot of aspects of culture. Here is hoping that is happening in the halls of government as well.