FDA seeks probe into communications between staff and Biogen over Alzheimer’s drug

BREAKING NEWS: FDA seeks probe into communications between its staff and Biogen after controversial approval of Alzheimer’s drug

  • FDA commissioner Janet Woodcock has asked for a probe into her staff’s communications with Biogen
  • Biogen’s Aduhelm received FDA approval for Alzhiemer’s disease in early June despite limited data that it worked in clinical trials  

The U.S. Food and Drug Administration (FDA) is asking for a federal investigation into its approval of a controversial Alzheimer’s drug.

Janet Woodcock, acting commissioner of the FDA, has asked for a probe into communications between FDA staff and Biogen representatives in the lead up to the approval of Aduhelm, the company’s Alzheimer’s drug.

The drug received FDA approval on June 7 despite limited data that it worked in clinical trials. 

The move comes after a turbulent month for the FDA and Biogen, a Cambridge Massachusetts based drug maker. 

In the weeks since approval, three members of an FDA advisory board have stepped down in protest of the drug’s approval, a congressional investigation has been launched and the agency even revised the drug’s label earlier this week.

Now the agency wants to look into its own communications to determine if proper procedure was followed in the lead up to the drug’s approval. 

“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

‘We believe this review and assessment will help ensure continued confidence in the integrity of FDA’s regulatory processes and decision-making.

‘If [The Office of the Attorney General] decides to conduct the review, the agency will fully cooperate & should they provide the agency with any recommendations, FDA would review expeditiously to determine the best course of action.

‘The trust of the American public, especially during these difficult times is of the utmost importance to the FDA – and we will continue to exercise transparency around our decision-making as allowed by the law. ‘

Woodcock has previously defended the drug’s approval from critics, saying it was ‘reasonably likely’ that the drug could help slow the cognitive decline associated with Alzheimer’s.

Some disagree, though, due to a rocky trial process by the drug manufacturer. 

 

This is a breaking news story and will be updated.