Members of Congress are requesting the U.S. Food and Drug Administration hand over documents regarding the agency’s controversial decision to greenlight Biogen’s Alzheimer’s drug, Aduhelm.
The FDA granted accelerated approval to the drug in June, despite concerns from experts—including the agency’s staff and members, among others—surrounding its clinical efficacy. Medical groups such as the Society of Nuclear Medicine & Molecular Imaging supported the decision but have since lobbied for an amyloid PET requirement to qualify for treatment.
In a Sept. 1 letter sent to Acting FDA Commissioner Janet Woodcock, two well-known House committee members said they are “concerned by apparent anomalies” in the agency’s review process along with reports of “unusual coordination” between the FDA and Biogen during the approval discussions.
House Energy and Commerce Chairman Frank Pallone, Jr. (D-N.J.) and Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) asked the FDA to provide data that the agency used during its approval decision process and for more information about who was involved.
Back in July, Woodcock urged the Office of Inspector General—part of HHS—to investigate Aduhelm’s approval. Later in August, OIG said it would review the FDA’s interactions, but lawmakers say they have more questions.
Part of their laundry list includes documents regarding the agency’s internal discussions about approving Aduhelm for a broader treatment indication than what was studied during clinical testing.
This has been a point of criticism from SNMMI, which has been lobbying for an amyloid PET mandate for patients seeking treatment. Individuals can also receive a lumbar spine puncture to qualify.
“All clinical trials for aducanumab have included amyloid PET imaging, and it is a key test in diagnosing Alzheimer’s disease,” an SNMMI spokesperson told Health Imaging over email in July.
As it stands, the House chairs say further insight into this matter is crucial to transparency. Radiology providers also say its approval could result in surging MR imaging volumes.
The committee members are asking the FDA to provide all requested information by Sept. 16.
“Aduhelm’s approval has far-reaching implications, not only for individuals with Alzheimer’s, but also for seniors, federal health care programs, and future research, development, and approval of drugs for Alzheimer’s and other diseases,” Pallone and Maloney concluded in their letter. “To help ensure that the American people continue to have the utmost confidence in FDA and the safety and efficacy of approved drugs, and to help inform future legislation, we need more information about FDA’s process for reviewing and approving Aduhelm.”
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.