Two congressional committees will investigate the FDA's approval of Biogen's Alzheimer's drug aducanumab, sold under the brand name Aduhelm.
The House Oversight and Reform Committee and House Energy and Commerce Committee are launching their investigation amid an intense debate in the pharmaceutical and medical communities over the drug's approval.
On June 7, the FDA approved Aduhelm, marking the first approval the agency has granted to an Alzheimer's treatment since 2003. Aduhelm is the first treatment approved by the FDA intended to slow cognitive decline from Alzheimer's disease, as the Alzheimer's drugs the FDA previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.
Critics of the approval say there was not enough evidence of clinical benefits to warrant an approval. From June 9-11, three members of the FDA's advisory committee resigned over the approval.
In addition to the drug's approval, the committees will also investigate its $56,000 annual list price.
"Our committees will be investigating this matter so Congress and the American people can better understand why this drug was approved, how Biogen set its price and what impact this will have on research for future Alzheimer’s treatments and federal health care programs," House Energy and Commerce Committee Chairman Frank Pallone Jr., D-N.J., and House Oversight and Reform Committee Chairwoman Carolyn Maloney, D-N.Y., wrote in a joint statement.