"I am hopeful these findings are a wake-up call for FDA 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," said Rep. Carolyn Maloney.
Nearly two years after a leading U.S. consumer advocacy group sounded the alarm on the matter, House Democrats released a report Thursday showing the Food and Drug Administration and pharma giant Biogen "inappropriately collaborated" prior to the controversial approval of a new $28,000-per-year Alzheimer's drug of questionable efficacy.
Originally carrying a $56,000 annual price tag for uninsured patients—which Biogen's then-CEO called "fair"—aducanumab, sold under the brand name Aduhelm, was approved by the FDA in June 2021. The approval came despite concerns that the drug—a monoclonal antibody treatment for patients with mild cognitive impairment caused by Alzheimer's—might not work, as well as safety trial data showing that a staggering 4 in 10 participants suffered potentially fatal brain bleeding and swelling after taking it.
"This report documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm."
The new report, the result of an 18-month probe by the Democrat-led House Oversight and Reform Committee and the Energy and Commerce Committee, found that the FDA's approval process for Aduhelm was "rife with irregularities," including an "atypical" number of meetings and other contacts between the agency and the Cambridge, Massachusetts-based drugmaker.
The panel also found that Biogen and the FDA closely collaborated on a document written for outside advisers during the approval process, with at least one paragraph of the company's submission authored by agency officials.
On pricing, the lawmakers concluded that Biogen gave Aduhelm an astronomical price tag knowing that doing so would place the drug out of reach for many patients—even those with insurance—and would cost Medicare $12 billion per year.
"This report documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm," outgoing House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) said in a
\u201cNEW: Chairman @FrankPallone and House Oversight Chair @RepMaloney release report on the controversial review, approval, and pricing of Biogen\u2019s Alzheimer\u2019s drug Aduhelm. \n\nThe full report here \ud83d\udc47 https://t.co/0GxsdKIWZ4\u201d— Energy and Commerce Committee (@Energy and Commerce Committee) 1672338215
"While we all support the search for new cures and treatments to address devastating diseases like Alzheimer's, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA," Pallone added. "Patient safety and drug efficacy must remain at the core of our nation's pharmaceutical regulatory review process."
House Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.), who will leave office when Republicans take over the lower chamber next week, said that "the number of patients and families impacted by Alzheimer's disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust."
"I am hopeful these findings are a wake-up call for FDA 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," she added.
The new report comes nearly two years after the consumer advocacy group Public Citizen warned of exactly the sort of questionable collaboration detailed in the publication.
"After aducanumab's two identical phase three trials were stopped in 2019 at the halfway point because a preliminary analysis found that they were unlikely to show the drug benefited Alzheimer's patients, the FDA and Biogen worked collaboratively to salvage the drug," the group wrote in January 2021. "They jointly relied on dubious analyses that over-emphasized the results of one phase three trial suggesting the drug may work at a high dose but disregarded data from the other phase three trial showing no benefit of the drug at any dose. The FDA and Biogen co-authored an unprecedented joint briefing document on aducanumab that was heavily biased in favor of the drug."
Reacting to the new report, Dr. Aaron Kesselheim—a former member of the FDA's outside advisory panel who voted against green-lighting Aduhelm and resigned after it was approved—toldThe Wall Street Journal Thursday that "I hope this inspires a full re-examination of the nature of the communications between FDA and industry."
"Lines of communication need to be at arm's length and transparent," he added, "so that there remains trust in the FDA's decisions."