On Friday, the Food and Drug Administration called for a federal investigation into the process that led to the approval of a new drug for Alzheimer’s disease, which spurred sharp criticism from lawmakers and the medical community.
To letter In an independent Department of Health and Human Services, FDA’s deputy commissioner, Dr. Janet Woodcock, acknowledged the scrutiny faced by the authorities on the $ 56,000 drug approval process, known as Aduhelm, an annual price tag. She noted the interaction between drug developer Biogen and agency representatives, saying it “may have occurred outside the formal communication process.”
“As long as these concerns can undermine public confidence in the FDA’s decision, I believe it is important for an independent body to review the event in question,” Dr. Woodcock wrote. I am. She said the review needed to find out if any of the communications between authorities’ staff and Biogen representatives violated FDA rules.
Biogen spokesman Dana Conti said the company “will, of course, cooperate with any investigations related to reviewing the regulatory process.”
It is unusual for an agency to require an investigation into the decision-making process of its staff for individual drug approval. This move could intensify the controversy surrounding Aduhelm. The FDA approved it a month ago, nullifying the fierce opposition of its own independent advisors and many other scientists. They said there was insufficient evidence to know if the drug was effective.
On Thursday, the FDA Moved to narrow that recommendation About who should receive the drug. Initially recommended for all patients with Alzheimer’s disease, the authorities’ new guidelines state that it should only be prescribed to people with mild cognitive impairment.
Last month, Dr. Aaron Kesselheim, one of the three experts who resigned from the FDA’s advisory board in protest of the FDA’s decision on Aduherm, said he welcomed the request for a federal investigation.
Dr. Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, said:
Many Alzheimer’s disease and public health experts have expressed concern about what they have characterized as an unusually close partnership between Biogen and the FDA while the drug is being reviewed. One example was the FDA’s independent advisory meeting in November 2019, an institutional move to present an enthusiastic review of evidence in support of the drug in collaboration with Biogen.
Medical news organization Stat, First reported In early May 2019, Dr. Billidan, Head of the Agency’s Department of Neuroscience, held an off-the-book meeting with Biogen executive Dr. Alsandrock. It’s not uncommon for pharmaceutical company executives to meet with FDA staff frequently, but it’s not uncommon to present data that is part of an FDA application outside of a formal setting.
A few months ago, Biogen moved to discontinue two late studies of Aduhelm after early analysis proved to be ineffective. However, Biogen researchers analyzing the data quickly concluded that the decision to discontinue the study was premature and there was reason to believe it might be effective in the end.
The May 2019 meeting between Dr. Dan and Dr. Sandrock was the first step in resuming negotiations 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, Stat reported that company and agency representatives worked closely together to clean up Biogen’s complex data from the study and communicate almost daily.
Aduhelm has been approved for the first time in 18 years for the treatment of Alzheimer’s disease. This was the first approval of a drug designed to not only delay symptoms, but also attack the biological basis of the disease.
The FDA is seeking its own investigation into Alzheimer’s disease approval
Source link The FDA is seeking its own investigation into Alzheimer’s disease approval