We noted previously that two congressional committees have begun investigations into how the FDA came to approve Aduhelm. Last week, both the House committees on Oversight and Reform as well as Energy and Commerce issued this letter to the FDA stating they are "concerned by apparent anomalies in FDA’s processes surrounding its review of Aduhelm.” And they "are also concerned by reports of unusual coordination between FDA and Biogen throughout the drug’s approval process.” The letter is 13 pages long, and it contains 15 very detailed questions regarding the process by which they approved the treatment and how they dealt with staff dissent. There are several probing questions concerning the FDA's relationship with Biogen. The committees are demanding the FDA's response by September 16 -- one week from today, which 15 days after the letter was issued.
For me, this is a sort of deja vu all over again. More than once, I've been in the middle of the maelstrom when a government agency was scrambling to provide answers to tough questions from a Senate committee on highly controversial issues. I once even carried the answers to Capitol Hill myself. So I don't envy them at the FDA.
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