The Meals and Drug Administration on Friday referred to as for a federal investigation of the method that led to the approval of a brand new drug for Alzheimer’s illness that has spurred sharp criticism from lawmakers and the medical neighborhood.
In a letter to the Division of Well being and Human Companies’ impartial Workplace of the Inspector Common, the F.D.A.’s performing commissioner, Dr. Janet Woodcock, acknowledged the scrutiny the company has confronted concerning the approval course of for the drug, which is called Aduhelm and has a $56,000 annual price ticket. She pointed to interactions between representatives from the drug’s developer, Biogen, and the company, saying some “could have occurred outdoors of the formal correspondence course of.”
“To the extent these issues may undermine the general public’s confidence in F.D.A.’s determination, I consider it’s vital that the occasions at problem be reviewed by an impartial physique,” Dr. Woodcock wrote. She famous that the assessment ought to have a look at whether or not any of the communication between the company’s workers and Biogen’s representatives violated F.D.A. guidelines.
Dana Conti, a spokesman for Biogen, mentioned the corporate “will, in fact, cooperate with any inquiry in reference to a attainable assessment of the regulatory course of.”
It’s uncommon for the company to request an investigation into its personal workers’s decision-making course of for a person drug approval. The transfer is prone to intensify the controversy that has surrounded Aduhelm. The F.D.A. permitted it a month in the past, overriding the fierce objections of its personal impartial advisers and lots of different scientists, who mentioned there was inadequate proof to know whether or not the drug was efficient.
- New Drug Permitted: The F.D.A. approved the first new Alzheimer’s treatment in 18 years, and the first to attack the disease process.
- Does New Drug Work?: Patient groups are desperate for new options, while several prominent Alzheimer’s experts and the F.D.A.’s own independent advisory committee objected to its approval, having raised concerns over lack of sufficient evidence of its effectiveness.
- Understand Alzheimer’s Disease: Get answers to common questions about the disease, which affects about 30 million people globally.
- One Face of Alzheimer’s: This profile of a woman in the early stages of the disease shows what it can be like to face the beginning symptoms and to consider the future.
On Thursday, the F.D.A. moved to narrow its recommendation about who should receive the drug. After originally recommending it for all Alzheimer’s patients, the agency’s new guidelines say it should be prescribed only to people with mild cognitive problems.
Dr. Aaron Kesselheim, one of three experts who quit an F.D.A. advisory panel last month in protest of the agency’s decision on Aduhelm, said he welcomed the call for a federal investigation.
“It’s really important that an investigation happen publicly and quickly so that we find answers to some of the many outstanding questions swirling around this decision,” said Dr. Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital.
A number of Alzheimer’s and public health experts have raised concerns about what they characterized as an unusually close collaborative relationship between Biogen and the F.D.A. while the drug was being reviewed. One example was the agency’s move to jointly present with Biogen its glowing review of the evidence supporting the drug in a meeting of the F.D.A.’s independent advisers in November 2019.
Stat, the medical news organization, first reported that in early May 2019, Dr. Billy Dunn, the head of the agency’s neuroscience division, held an off-the-book meeting with a Biogen executive, Dr. Al Sandrock. While it is not unusual for drug company executives to meet frequently with F.D.A. officials, it is unusual to present data that would be part of an F.D.A. application outside a formal setting.
A few months earlier, Biogen had moved to halt two late-stage studies of Aduhelm after an early analysis found that it would not prove to be effective. But Biogen researchers analyzing the data soon concluded that the decision to halt the studies had been premature and that they had reason to believe it might be effective after all.
The May 2019 meeting between Dr. Dunn and Dr. Sandrock was an initial step in restarting the talks that led to last month’s approval. It led to the first of a series of standard formal meetings between Biogen and agency staff. It also led to a more unusual collaboration: That summer, representatives from the company and the agency worked closely together to sort through Biogen’s complicated data from the studies, communicating nearly every day, Stat reported.
Aduhelm was the first drug approved to treat Alzheimer’s in 18 years — and it was the very first approval for a drug designed to attack the biological underpinnings of the disease, instead of just delaying symptoms.