The U.S. Food and Drug Administration's approval process for the controversial Alzheimer's drug Aduhelm was "rife with irregularities," despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims.
Actions the agency took with Biogen, maker of Aduhelm, "raise serious concerns about FDA's lapses in protocol," the report concluded. But the 18-month investigation launched by two congressional committees also took Biogen to task for setting too high a price on the medication.
Company documents showed Biogen officials settled on an annual cost of $56,000 for Aduhelm because it wanted 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.
Not only that, Biogen planned to spend up to several billion dollars on an aggressive marketing campaign to target doctors, patients, advocacy groups, insurers, policymakers and communities of color, who were drastically underrepresented in the company's clinical trials of the drug.
The controversy over Aduhelm (aducanumab) stretches back to its June 2021 approval. The Cleveland Clinic and the U.S. Department of Veterans Affairs, among others, decided not to offer Aduhelm infusions following the approval because of the drug's questionable efficacy and risks of brain swelling and bleeding.
Once Medicare sharply limited its coverage of Aduhelm, still expensive after the annual price was halved to $28,800, the drug was essentially sidelined from the marketplace, the New York Times reported.
What was so unusual about the FDA's approval process for Aduhelm?
According to the report, an unusual arrangement called a "collaborative workstream" began in July 2019, where FDA officials met repeatedly with Biogen to analyze data from one failed trial and another that seemed slightly successful, helping advise whether the company should seek approval for the drug.
Over the course of 12 months, there were at least 52 meetings, and not all were documented properly under FDA standards, the report added. Also, “there was no official memorialization of at least 66 calls or substantive email exchanges,” the report said.
The latest hard look at Aduhelm comes as the FDA is now evaluating two other Alzheimer's drugs for possible approval early next year, including one that Biogen helped develop, the Times reported.
In light of that, the report stressed that 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 FDA's review."
In response, the FDA said in a statement that "we fully cooperated with the committees' evaluation and we continue to review their findings and recommendations," the Times reported.
But it added that the agency needs to frequently interact with companies during an approval process. "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 committees' recommendations."
Meanwhile, Biogen defended its drug following the report's release.
"Biogen stands by the integrity of the actions we have taken. As stated in the congressional report, an FDA review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation," the company said in a statement.
Still, members of the investigating congressional committees had harsh words for both the FDA and Biogen, the Times reported.
Rep. Frank Pallone (D.-N.J.), chair of the House Energy and Commerce Committee, said in a statement that the report "documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm."
His committee conducted the investigation with the House Committee on Oversight and Reform, chaired by Rep. Carolyn Maloney (D.-N.Y.). In a statement, she said she hoped the report would be "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."
Visit the FDA for more on Aduhelm.
SOURCES: New York Times; U.S. House of Representatives Report, Dec. 2022