The FDA has a well established process for the approval of therapeutics. It has had bumps from time to time but it is also often showed in its own arcane rules and procedures. The FDA is highly sensitive to who says what to whom and when. Just try to visit someone at an FDA facility, it is easier to visit the CIA!
However the emergency approval of the vaccines was pushed successfully by the former President and frankly may have saved hundreds of thousands of lives. Now for final approval we seem to be back at the classic slow pace of the FDA. As the NY Times notes;
Full approval typically requires the F.D.A. to review hundreds of thousands of pages of documents — roughly 10 times the data required to authorize a vaccine on an emergency basis. The agency can usually complete a priority review within six to eight months and was already working on an expedited timetable for the Pfizer vaccine. ... Dr. Peter Marks, the agency’s top vaccine regulator, wrote that undue haste “would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.” The regulators want to see real-world data on how the vaccine has been working since they authorized it for emergency use in December. That means verifying the company’s data on vaccine efficacy and immune responses, reviewing how efficacy or immunity might decline over time, examining new infections in participants in continuing clinical trials, reviewing adverse reactions to vaccinations and inspecting manufacturing plants.
The problem is transparency. If the FDA let the public know what the process was and why and how far it has gone then I believe trust would increase. Instead the remark by the FDA administrator above in my opinion creates more doubt and does more harm than good.
We have noted that the CDC does not seem to work weekends, and we also know from experience that after 3 PM on a Friday is not a time to find someone at the FDA.
These are stressful times. The non-Government workers are straining to keep afloat and pay our taxes to support the Government employees.
Perhaps if the FDA folks explained to the citizens the process, the status, and the like, people would have increased confidence. They really should not berate people for pushing them along at a faster pace. That does just the opposite of what they state. They are Government workers, they work for the people, respect that.
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