In normal times, when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional “gold standard” in relation to the decision-making process for the approval of new treatments. That standard is even more important now, as we approach a time when critical clinical data will be emerging around the various vaccine candidates now being studied. That is especially so since a successful vaccine – and the generous uptake of that vaccine by a skeptical public – is a cornerstone to getting out of this mess.
That is why – pre-pandemic – I wrote this blog posting in December – Remaining Aloof from Politics – citing the action by the FDA press office to issue a press release that took on a political cast, using the name of the president in the headline and sounding like a cheerleader rather than an independent government agency when appearing so might compromise the agency’s all important credibility.
Since then, and almost at the outset of the pandemic, a number of FDA actions have caused further concern for the agency’s credibility.
- In March the FDA had pledged availability of 1,000,000 coronavirus tests – a position promptly called into question when the tests did not appear;
- There was a messy rollout of policy around the development of antibody tests for SARS-CoV-2 that resulted in confusion around policy;
- Then came the issuance of an emergency use authorization for use of hydroxychloroquine, an unproven diagnostic and preventive touted by President Trump which was revoked within a few weeks
Now, over the weekend, FDA issued an emergency use authorization for the use of convalescent plasma with the issuance of a ham-handed, politicized headline on the agency’s press release – “FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID-19 Treatment, Another Achievement in Administration’s Fight Against Pandemic“.
The approach in this approval and the communications around it raises concern as we enter a phase in the process whereby critical data from vaccine trials will begin to be collected and preliminary effects assessed. Already there are many within the public who are not part of the anti-vax movement who are skeptical about the vaccine. One recent poll by Gallup showed that one-third of Americans say they will not take the vaccine while less than half indicated they would in an NBC poll. Muddying the waters even further are the tweets insinuating the existence of a “deep state” effort to stymie progress.
It is in our public health interest, as well as our collective economic interest, to have viable vaccines not only developed, but utilized by the public. That means that as much as possible, there must be confidence in the end product, supported by the process of assessment and approval. There must be confidence in FDA that is supported, not inhibited by the Executive Branch. Credibility is nearly as much as a key factor as the science. Even the appearance of political pressure for a specified outcome should be avoided at all costs. We can only hope that when the time comes, the Administration and the FDA both do a better job of it than they have with the issuance of this emergency use authorization.