Henry Miller in WSJ: Debating the FDA’s Vaccine Approval Delay

Henry Miller in WSJ: Debating the FDA’s Vaccine Approval Delay

To the editor of the Wall Street Journal:

Your editorial contains the statement: “There’s no evidence that a three-week review is needed.” You know this how, exactly? Has anyone at the Journal seen the data (which run to hundreds of thousands of pages)? Has anyone at the Journal ever seen, let alone touched, an application for approval of a drug or vaccine? I have. As an FDA reviewer, I found extraordinary complexity, and sometimes shortcomings or inconsistencies, in many submissions . . .