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

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.   

Biogen launched two clinical trials for Aduhelm, the commercial name of the drug aducanumab, in 2016.

Both were stopped midway because researchers concluded that neither trial would end up reaching its goal.

Later, the company revealed updated data from the second study that showed patients had 22 percent decrease in speed of their cognitive decline.

It also showed that it could remove amyloid beta plaques on the brain that some experts believe can reduce the cognitive decline caused by Alzheimer’s.

Woodcock and others have said that the removal of these plaques can stop cognitive decline, which would make the drug the only available Alzheimer’s treatment to do so.  

The FDA has since rolled back a bit on the drug.

Earlier this week, they revised its label, now only recommending it to be prescribed to those in the early stages of Alzheimer’s, or with more mild case of the condition. 

Three FDA advisory board members, Dr David Knopman of the Mayo Clinic, Dr Aaron Kesselheim of Harvard University and Dr Joel Perlmutter of Washington University St Louis, stepped down last month.

All three were among the opposition in the board’s 10-0 vote against approving Aduhelm.

Recommendations from the board are not binding, though, and the FDA is allowed to, and often does, make decisions that go against the board’s vote.

It is rare that a unanimous decision by the board is ignored, though, and the agency is generally more conservative than experts on the board – which was not the case with Aduhelm.

Knopman authored a study in November which analyzed the results of the clinical trials, and said he disagreed with Biogen’s claim that the drug was effective.

Kesselheim had some scathing words about the drug’s approval as well.

‘[Aduhelm] is probably the worst drug approval decision in recent U.S. history,’ Kesselheim wrote in a letter to FDA Commissioner Janet Woodcock obtained by Stat News.

‘It is clear to me that FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.’

 

This is a breaking news story and will be updated.