Congressional Democrats launch probe into Biogen's Aduhelm FDA approval, citing 'serious concerns'

Biogen biologics plant in Denmark
House Democrats will launch an investigation into the FDA's approval for Biogen's Aduhelm as well as the company's $56,000 list price. (Biogen)

The rumblings on Capitol Hill over Biogen Alzheimer's disease drug Aduhelm have been growing louder in recent days as lawmakers began speaking out about its lofty price tag and controversial FDA win.

Now, two high-ranking Democrats want answers.

The House Committee on Oversight and Reform announced Friday that it will launch an investigation into the Alzheimer's drug's hotly debated FDA approval and pricing.

Spearheaded by Chairwoman Rep. Carolyn Maloney, D-New York, and Rep. Frank Pallone Jr., D-New Jersey, chairman of the House Committee on Energy and Commerce, the inquiry will address "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," the lawmakers said.

Earlier this month, the medicine became the first treatment for Alzheimer’s in nearly two decades to cross the agency's finish line, but its debut has come with a heap of concerns and criticisms.

Many have criticized Biogen’s decision to set Aduhelm’s list price at $56,000 per year, well above what analysts and advisory groups had predicted, even though the drug showed murky benefits in clinical trials.

RELATED: Biogen's $56K Alzheimer's drug is rounding up bipartisan drug pricing critics in Washington

Through the investigation, the lawmakers plan to find out what led to the FDA’s accelerated approval and Aduhelm's wide label. That broad label is another common point of concern, opening the door for use by all Alzheimer’s patients versus just patients with early-onset disease as studied in clinical trials.

The lawmakers also took aim at the FDA’s decision to approve Aduhelm based on a surrogate endpoint, the removal of amyloid plaque, rather than slowing cognitive decline. The agency’s move also went against a resounding no vote from the agency’s own independent advisers late last year, prompting three of those members to quit in protest, the representatives pointed out.  

Biogen’s not off the hook, either. The lawmakers want to know what went on behind the company's pricing strategies, which “will have broader implications for seniors, providers, and taxpayers.”

Before the congressional inquiry announcement, Biogen issued a lengthy response Wednesday promising to work with public and private insurers to ensure Aduhelm doesn't break their budgets. CEO Michel Vounatsos vigorously defended Aduhelm's price, arguing it's "substantiated by the value it is expected to bring to patients, caregivers and society.”

Meanwhile, the FDA has also pushed back against critics. The agency’s top leadership wrote in a Washington Post op-ed on Wednesday that Aduhelm was able to substantially lower amyloid plaque, a defining characteristic of Alzheimer’s, better than other similar drugs that have previously failed.

RELATED: A $57B drug? Medicare faces a massive bill for Biogen's Aduhelm—even if it limits coverage

The committee's investigation, the first from Washington over the FDA’s Aduhelm decision, is just the latest in a series of steps lawmakers have taken in recent days to push back against Aduhelm’s approval and cost.

In a letter to the Senate Finance Committee on Wednesday, ]Sens. Elizabeth Warren, D-Massachusetts, and Bill Cassidy, R-Louisiana, called for a hearing to “examine the vexing new questions and challenges” the newly FDA-approved Aduhelm poses to the Medicare program.

It’s thought that most of the 6 million Americans with Alzheimer’s are enrolled in the federal insurance program, which could eventually balloon the program’s spending above the cost of all current Part B drugs.

Even if just a quarter of the 2 million Medicare enrollees who currently use an Alzheimer’s treatment end up prescribed to Aduhelm, total spending would reach $29 billion for one year alone, the Kaiser Family Foundation found in a recent report.

“This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency,” Warren and Cassidy wrote in their letter.