(Bloomberg) -- Two key House Democrats are opening a joint committee investigation into Biogen Inc.'s new Alzheimer's drug, saying its approval and high cost create questions about the regulatory process.
“We have serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit,” Oversight and Reform Committee Chairwoman Carolyn Maloney and Energy and Commerce Committee Chairman Frank Pallone said in a statement Friday.
The therapy's $56,000 annual price tag is drawing increasing ire ahead of a government decision on reimbursement policies. The Food and Drug Administration granted Aduhelm an accelerated approval this month over the objections of an advisory committee that found a lack of clear evidence to show it could slow cognitive decline. Since then, three FDA advisory committee members have resigned.
Democratic Senator Elizabeth Warren and Republican Senator Bill Cassidy have called for a Senate Finance Committee hearing on the drug. Senator Joe Manchin, a moderate Democrat and crucial vote in the Senate, said that FDA acting head Janet Woodcock should be quickly replaced with a permanent leader. Manchin's attack could potentially dim Woodcock's chances of being nominated for that role.
Biogen had conducted two large trials on the therapy with conflicting results. Following the FDA's accelerated approval, the drugmaker has nine years to submit data on the drug's efficacy, and will likely make billions of dollars from selling it over that span.
Medicare could spend $57 billion per year on Aduhelm, according to a Kaiser Family Foundation analysis. The figure represents more than Medicare Part B spends each year on all other drugs combined, Maloney and Pallone said.
The Democratic chairs said the committees will probe the how the 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.”
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