Biogen's Alzheimer's drug spurs controversy

It was historic news last month for pharmaceutical company Biogen and people with Alzheimer's disease when the Food and Drug Administration (FDA) approved the first new drug of any kind for treating Alzheimer's in two decades. But now the company and its drug, Aduhelm, are surrounded by controversy.

Two House Democrats on Monday asked Biogen for all documents from 2018 onward related to the development of the drug, the company's communications with the FDA, and plans for pricing and commercializing, among other requests. Biogen was asked to respond by July 26.

The FDA itself is investigating its own approval of the drug. Acting FDA Commissioner Janet Woodcock on July 9 asked for an independent government investigation into the approval process from the inspector general that oversees the agency.

In a letter to the Health and Human Services' independent office of the inspector general, Woodcock noted that there "continues to be concerns raised" regarding the contact between FDA officials and Biogen ahead of the agency's decision, "including some that may have occurred outside of the formal correspondence process".

"To the extent these concerns could undermine the public's confidence in FDA's decision, I believe it is critical that the events at issue be reviewed by an independent body," Woodcock wrote.

Biogen and the FDA have faced mounting criticism since the early June decision to allow the drug on the market, overriding the fierce objections of its own independent advisers and many other scientific advisors.

On July 8, the FDA narrowed its recommendation about who should receive the drug. After originally recommending it for all Alzheimer's patients, the agency's new guidelines say it should be prescribed only to people with mild symptoms of the degenerative memory-loss disease that affects 6 million people in the US.

A number of Alzheimer's and public health experts have raised concerns about what they characterized as an unusually close collaborative relationship between Biogen and the FDA while the drug was being reviewed.

Stat, the medical news organization, first reported what lawmakers called a "secret campaign" by Biogen, called Project Onyx, to get the FDA to approve the drug after two large trials were halted in 2019 when an independent committee deemed them unlikely to succeed.

Now, the lawmakers want Biogen to turn over details about Project Onyx.

"We are concerned by reports of an atypical approval process for Aduhelm amid significant questions about the drug's clinical benefit, and the steep $56,000 annual price tag, which will have serious implications for seniors, federal health-care programs, and future Alzheimer's research," wrote Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Frank Pallone Jr, chairman of the House Committee on Energy and Commerce.

The US government on Monday also started a review process for national Medicare coverage of the drug. The coverage determination will decide whether Aduhelm is a "reasonable and necessary" treatment. If so, Medicare, the federal government's health-insurance program for the elderly, is required by law to pay for it.

The treatment has the potential to create a substantial burden for Medicare. A Kaiser Family Foundation analysis published in June suggested that Aduhelm could cost the program $29 billion a year.

"We want to consider Medicare coverage of new treatments very carefully in light of the evidence available," Centers for Medicare and Medicaid Services administrator Chiquita Brooks-LaSure said in a statement.

Currently, coverage for the drug is determined at the local level by Medicare administrative contractors, who represent 12 jurisdictions across the country.

"While the company has claimed this price is 'fair' and 'substantiated by the value it is expected to bring,' an independent analysis determined that a fair price for Aduhelm would be a small fraction of Biogen's price," said Maloney and Pallone.

The committee chairs noted that a nonprofit think tank focused on drug pricing pegged the drug's actual value at between $3,000 and $8,400 per year, based on its unproven benefits.