Since the FDA approved Biogen's Alzheimer's drug Aduhelm June 7, a flurry of controversy has followed, including physicians resigning from the FDA's advisory committee and reports showing how the drug could dramatically escalate U.S. healthcare spending.
Five recent updates on news about Aduhelm:
- Both Cleveland Clinic and New York City-based Mount Sinai have said they won't administer Aduhelm to patients. The systems said they will reevaluate their decision when more data on the drug is available. Cleveland Clinic physicians can still prescribe Aduhelm, but patients will have to go somewhere else to receive it.
- The FDA's acting commissioner, Janet Woodcock, MD, requested that the HHS Office of Inspector General conduct an independent review of the correspondence between the FDA and Biogen during Aduhelm's approval process.
- Biogen updated Aduhelm's label to specify that it should only be used in Alzheimer's patients early in the disease's progression. The FDA has approved the updated label.
- Two congressional committees — the House Oversight and Reform Committee and House Energy and Commerce Committee — will investigate the FDA's approval of Aduhelm.
- CMS began its review of whether it will standardize coverage of Aduhelm July 12. Medicare will analyze clinical studies on the drug and medical society guidelines. Two public hearings assessing the drug's benefits, slated to take place later in July, will also be part of the evaluation process.