The Food and Drug Administration’s Commissioner Robert Califf has defended the agency’s approval of the new Alzheimer’s drug called Aduhelm. This follows an investigation by House Democrats which found close cooperation between the drug’s sponsors and regulators. The findings were made by the Oversight and Reform Committee and the Energy and Commerce Committee which found an unusual number of meetings between Biogen Inc. and the FDA. The FDA also co-authored with the company a briefing document presented to outside advisors, which is very unusual. Unfortunately, the drug was pulled off the market because Medicare refused to cover the expensive drug.
