WASHINGTON (AP) — The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency's drug reviewers and the maker of a controversial new Alzheimer's drug.
Dr. Janet Woodcock announced the extraordinary step via Twitter. It's the latest fallout over last month's approval of Aduhelm, an expensive and unproven therapy that the agency OK'd against the advice of its own outside experts.
Woodcock made the request to the Department of Health and Human Services’ inspector general, the watchdog agency that oversees the FDA and other federal health agencies. The move comes after numerous calls for a probe into the approval from medical experts, consumer advocates and members of Congress. Two congressional committees have already launched their own review.
“We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” Woodcock wrote on Twitter. Biogen pledged to cooperate with the inquiry.
Last month, the health news site Stat reported on the unusually close collaboration between Aduhelm drugmaker Biogen and FDA staff. In particular, the site reported an “off-the-books” meeting in May 2019 between a top Biogen executive and the FDA's lead reviewer for Alzheimer's drugs.
The meeting came after Biogen stopped two studies because the drug didn't seem to slow the disease as intended. Biogen and the FDA began reanalyzing the data together, concluding the drug may actually work. The collaboration ultimately led to the drug's conditional approval two years later, on the basis that it reduced a buildup of sticky plaque in the brain that is...
