Two House committees on Friday announced they are launching an investigation into the Food and Drug Administration’s (FDA) controversial approval of a new Alzheimer’s drug, including the drug’s $56,000 a year price.
The announcement from House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) and House Oversight and Reform Committee Chairwoman Carolyn MaloneyCarolyn MaloneyHillicon Valley — Presented by Xerox — EU calls out Russian hacking efforts aimed at member states House lawmakers ask Cyber Ninjas CEO to testify on Arizona audit House Oversight demands answers on CBP's treatment of Haitian migrants MORE (D-N.Y.) comes as the approval of Biogen’s drug Aduhelm earlier this month has provoked an outcry on numerous fronts.
The FDA has faced questions as to why it approved the drug given doubts about whether it actually works. The FDA’s advisory committee had recommended against approval, and three members resigned in protest of the approval.
The drugmaker, Biogen, then priced the treatment at $56,000 a year, stirring additional controversy and furthering Democratic calls for the government to lower drug prices.
“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,” Pallone and Maloney said in a statement.
“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,” they added.
The Kaiser Family Foundation has estimated that if 1 million Medicare beneficiaries take the drug, it would cost Medicare $57 billion per year, a price that is more than Medicare Part B currently spends on all other drugs combined.
"In 2017, nearly 2 million Medicare beneficiaries used one or more of the currently-available Alzheimer’s treatments," according to the Kaiser Family Foundation.
“We strongly support innovative treatments to help the millions of Americans who suffer from Alzheimer’s disease, but Aduhelm’s approval and its $56,000 annual price tag will have broader implications for seniors, providers, and taxpayers that warrant close examination,” Pallone and Maloney said.