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.
Especially when a product will potentially be administered to hundreds of millions of healthy Americans, meticulous care is necessary.
Oh, and by the way, my team approved the first biopharmaceutical, human insulin, in what was then record time for a new drug application: five months, in 1982.
Henry I. Miller, M.D.
Redwood City. Calif,
Dr. Miller was founding director of the FDA's Office of Biotechnology.