08-23-2020, 02:48 PM
I am going to crawl out on a limb here a bit and say the FDA was undoubtedly intending to issue an EUA for convalescent plasma until Dr. Anthony Fauci and Dr. Francis Collins, (as well as others) raised their concerns. How much effect anybody else from the administration had on getting the FDA to proceed with the EUA is unknown. Given the other EUAs that have been given for COVID-19 related things, I think it would be very difficult for the FDA to not grant one in this case. I would expect that this therapy will be very closely followed by the FDA and the EUA will be withdrawn if any safety issues show up.
Unfortunately, this approval will probably greatly reduce the odds of a real placebo controlled study on this therapy. This therapy already suffers from the fact that nobody is going to make real money on it, so the incentive to do a real good clinical trial is lacking. Additionally, it is probable this therapy will be obsolete within a year, replaced by monoclonal antibodies and/or a vaccine.
As far as political pressure on the FDA goes, there often is some, from many quarters. In general, I think the worst effect of the pressure is that it creates the impression that any action the FDA eventually takes was not freely chosen. This undermines the FDA's credibility, usually for no reason. The FDA lives in the real world. They are very powerful, but they also know that people need the therapies they are asked to approve (or not). Usually, the FDA errs on the side of caution. With the COVID-19 epidemic, that is not nearly so true.
Unfortunately, this approval will probably greatly reduce the odds of a real placebo controlled study on this therapy. This therapy already suffers from the fact that nobody is going to make real money on it, so the incentive to do a real good clinical trial is lacking. Additionally, it is probable this therapy will be obsolete within a year, replaced by monoclonal antibodies and/or a vaccine.
As far as political pressure on the FDA goes, there often is some, from many quarters. In general, I think the worst effect of the pressure is that it creates the impression that any action the FDA eventually takes was not freely chosen. This undermines the FDA's credibility, usually for no reason. The FDA lives in the real world. They are very powerful, but they also know that people need the therapies they are asked to approve (or not). Usually, the FDA errs on the side of caution. With the COVID-19 epidemic, that is not nearly so true.