Woodcock wrote she has “tremendous confidence in the integrity of the staff and leadership” in the FDA’s Center for Drug Evaluation and Research involved in the review of the drug, aducanumab, and sold as Aduhelm.
“There continue to be concerns raised, however, regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the form correspondence process,” Woodcock wrote to to OIG Acting Inspector Christi Grimm.
“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures.”
A Biogen spokesperson said in a statement to CNN, “We will, of course, cooperate with any inquiry in connection with a possible review of the regulatory process.”
A request from FDA does not guarantee there will be an investigation. In a statement, a spokesperson for the HHS OIG said the office received Woodcock’s letter and is reviewing it for appropriate action.
On June 7, aducanumab was approved with the FDA’s “accelerated approval” to treat Alzheimer’s disease, despite an earlier vote from an FDA advisory committee that there was not enough evidence to support the drug’s clinical efficacy. Three members of the advisory committee resigned following the approval decision. Biogen also faced criticism over the price — a high dose is expected to cost $56,000 per patient per year.