Congressional Inquiry into Alzheimer’s Drug Faults Its Maker and F.D.A.

NYT HEALTH: Congressional Inquiry into Alzheimer’s Drug Faults Its Maker and F.D.A.
By Pam Belluck
Section: Health
Source: New York Times
Published Date: December 29, 2022 at 02:00AM

The report said the F.D.A.’s approval process for Aduhelm was “rife with irregularities” and criticized Biogen for setting an “unjustifiably high price.”

The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.
The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found.
The investigation said Biogen was prepared to spend up to several billion dollars — more than two-and-a-half times what it spent developing the drug — on aggressive marketing to counter expected “pushback” over whether Aduhelm was worth its price. The report said the campaign planned to target doctors, patients, advocacy groups, insurers, policymakers and communities of color, who were drastically underrepresented in its clinical trials of the drug.
The F.D.A. is now evaluating two other Alzheimer’s drugs for possible approval early next year, including one that Biogen helped develop. The congressional report said the agency “must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubts about the integrity of F.D.A.’s review.”
Representative Frank Pallone, a Democrat and chair of the House Energy and Commerce Committee, said in a statement that the report “documents the atypical F.D.A. review process and corporate greed that preceded F.D.A.’s controversial decision to grant accelerated approval to Aduhelm.”
His committee conducted the investigation with the House Committee on Oversight and Reform, chaired by Representative Carolyn Maloney, also a Democrat. In a statement, she said she hoped the report would be “a wake-up call for F.D.A. to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don’t put profits over patients.”
In a statement, the F.D.A. said: “We fully cooperated with the committees’ evaluation and we continue to review their findings and recommendations.”
It also said it was the agency’s job to frequently interact with companies to collect accurate information. “We will continue to do so, as it is in the best interest of patients,” the statement said. “That said, the agency has already started implementing changes consistent with the committee’s recommendations.”
“Biogen stands by the integrity of the actions we have taken,” the company said in a statement. It added, “Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm.”
Aduhelm’s approval in June 2021 caused an outcry from many Alzheimer’s experts. Major health systems, including the Cleveland Clinic and the Department of Veterans Affairs, decided not to offer Aduhelm, an intravenous infusion, citing its uncertain benefits and risks of brain swelling and bleeding. After Medicare sharply limited its coverage of Aduhelm, the drug — still expensive even after Biogen halved its annual price to $28,800 — was essentially sidelined from the marketplace.

Read more: https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html

HEALTH News and Tweets