How The FDA Works

How The FDA Works (Hint: It’s Not At Warp Speed)


Leonard Zwelling

This blog has assiduously avoided writing about the FDA and in particular its Commissioner, Steve Hahn despite Dr. Hahn’s frequent appearance in the news during the pandemic. The reason is obvious. He’s my friend and a very good friend of Coach K (Dr. Kleinerman). As most of the world knows, Steve did a sterling job leading MD Anderson through some difficult waters along with Marshall Hicks in the time when Anderson had no permanent president. He is obviously a very able academic administrator who had the fortune of having the opportunity to stretch his wings in Rockville at the FDA while having the poor timing of starting just days before the coronavirus crisis emerged.

Now, as the attached story relates, Dr. Hahn is under renewed pressure from the White House to approve the use of coronavirus vaccines as soon as possible. Well, that’s just what he’s doing. He can’t really go any faster.

The FDA must wait for the opinion of its advisory group on vaccines that met on December 10 (yesterday) to review the application from Pfizer for an emergency use authorization for their vaccine. (It was approved). Even an EAU is not full approval, but it would allow doses of the vaccine to be administered to front line health care workers this month. The logistics to make this happen were already underway before the December 10 meeting. However, the FDA cannot approve the EUA BEFORE that meeting because it cannot by law. It must await the input from the panel whose members who reviewed the submitted data. So did the FDA’s scientists. I am sure there was a pile of information for each advisory board member and FDA employee to digest and even the December 10 date was ambitious. Beating on the head of the FDA Commissioner is no way to get what you want, Mr. Trump. Read the rules. Educate yourself. This is a process and it’s one that takes a little time. Most importantly, this is a scientific process, not a political one and this process cannot be hurried, nor does anyone want it to be for fear an error will be made.

There has been particular focus in the press on the efficacy of the various vaccines reported from the phase three trials to date. While thousands of people got the vaccine (or a placebo) only hundreds have gotten sick with covid and the vast majority of those got the placebo as ascertained by the data safety monitoring boards for each trial. These boards have the ability to break the blinded codes and know which covid patients got real vaccine and which placebo. Ninety or so percent of the sick people got placebo in all of these trials so this is looking very good. The safety data have not been released before but were on December 10. Personally, that’s what I want to see. I am not interested in the percentage of who got what side effects. I want to know the absolute numbers of who got sick and with what. Then I want to be sure that all of these human subjects will continue to be followed in the subsequent months to be assured that there are no long-term side effects of a major nature. I would also like to see the levels to which the subjects’ antibodies rose and for how long they remained up as this will signal whether reinfection is likely and, if so, how might this be prevented (annual vaccination).

Mr. Trump needs to leave Dr. Hahn alone. He’s moving as fast as the process allows and none of us should want him to go any faster. If HHS Secretary Alex Azar cannot explain this to President Trump (I am sure he’s tried) perhaps we are getting a cogent example of why Mr. Trump is such a bad president and why he lost.

The process to get everyone vaccinated has begun and is moving at warp speed, just as the project is named. That’s fast enough. Let the scientists do their work. Science does not care about political schedules and certainly does not care about presidential egos. Mr. Trump, get off the FDA’s back.

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