Aug. 31, 2020, 3:30 AM CDT
By Andy Slavitt, former acting administrator of the Centers for Medicare & Medicaid Services
If you walked into the offices of the Food and Drug Administration tomorrow and claimed a miracle cure that could save 35 percent of those infected with COVID-19, the first thing the FDA would do is examine those claims rigorously. Validating claims of effectiveness is one of the most important and painstaking of the FDA's jobs. If those claims turned out to be false, your company could face massive civil and criminal liability.
As America enters an election season, Hahn has indicated he is willing to potentially put aside scientific concerns for political ones.
And yet, on Aug. 23, in announcing the emergency use authorization, or EUA, to approve "convalescent plasma," that is exactly what happened. Only the misrepresentation of the treatment's effectiveness wasn't made by a fraudulent company or greedy inventors — it was made by FDA Commissioner Stephen Hahn.
In doing so, Commissioner Hahn has tipped his hand. As America enters an election season with the coronavirus very much out of control, Hahn has indicated that he is willing to potentially put aside scientific concerns for political ones. This is dangerous for a variety of reasons. The most important one is the very real possibility that President Donald Trump may want to lie to the public about a possible vaccine before the election and that Hahn would go along with it.
Let's retrace what happened. In a news conference on the eve of the Republican National Convention, Hahn stood alongside Trump and said "35 out of 100 people" treated with convalescent plasma would survive. Trump labeled this a "breakthrough."
The statement was exactly the kind that would deliver the harshest rebuke from the FDA. Because it was a lie.