Congressional report criticizes FDA, drugmaker for approval of Alzheimer’s drug Aduhelm

The US Food and Drug Administration’s approval process for controversial Alzheimer’s drug Aduhelm is “fraught with irregularities”, although doubts remain about its ability to slow the disease. this expensive drug, a congressional report released on Thursday claims.

The actions the agency has taken with Biogen, the maker of Aduhelm, “raise serious concerns about FDA flaws in protocol,” report conclusion. But an 18-month investigation led by two congressional committees also held Biogen responsible for overpricing the drug.

Company documents show that Biogen officials dealt with a annual cost $56,000 for Aduhelm because it wanted to “establish Aduhelm as one of the top pharmaceutical companies of all time,” even though they knew the high prices would burden Medicare and patients, the report found.

Not stopping there, Biogen has planned to spend several billion dollars on a massive marketing campaign aimed at doctors, patients, Advocacy groupsinsurers, policymakers, and communities of color, who are underrepresented in clinical trials of the company’s drugs.

The controversy over Aduhelm (aducanumab) has dragged on since its approval in June 2021. The Cleveland Clinic and the U.S. Department of Veterans Affairs, among others, decided not to provide the Aduhelm infusion after it was approved. approved because of the drug’s questionable effectiveness as well as the risk of brain swelling and bleeding.

After Medicare drastically restricted Aduhelm’s coverage, which was still expensive after the annual price halved to $28,800, the drug was essentially taken off the market, the New York Times reported.

What is unusual about the FDA approval process for Aduhelm?

According to reports, an unusual arrangement known as a “collaborative workflow” began in July 2019, in which FDA officials met with Biogen multiple times to analyze data from a trial. failed, and another trial appeared to be somewhat successful, providing advice on whether the company should seek approval. medicine.

Over the course of 12 months, there were at least 52 meetings, and not all of them were properly recorded according to FDA standards, the report added. Additionally, “there is no official memorial to at least 66 substantive email calls or exchanges,” the report said.

The latest insight into Aduhelm comes as the FDA is currently evaluating two other Alzheimer’s disease drugs for possible approval as early as next year, including one that Biogen helped develop, the Times reported. .

As such, the report stresses that the agency “must act quickly to ensure that its processes for reviewing future Alzheimer’s treatments do not lead to similar doubts about the truthfulness of their claims.” FDA review.”

In response, the FDA said in a statement that “we fully cooperate with the committee’s review and we continue to review their findings and recommendations,” the Times reported.

But it added that the agency needs to regularly interact with companies during the approval process. “We will continue to do so, as it is in the best interest of our patients,” the statement said. “That said, the agency has already begun making changes consistent with the committee’s recommendations.”

Meanwhile, Biogen protects medicine after the release of the report.

“Biogen supports the integrity of the actions we took. As stated in the congressional report, an FDA review concluded that, ‘There is no evidence to suggest these interactions. with the sponsor before applying is anything but appropriate in this situation,'” the company said in a statement. statement.

However, members of the congressional investigative committee had harsh words for both the FDA and Biogen, the Times reported.

Representative Frank Pallone (D.-NJ), the chairman of the House Energy and Commerce Committee, said in a statement that the report “documents the FDA’s atypical review process and the greed of regulators. company in light of the FDA’s controversial decision to expedite approval of Aduhelm.”

His committee conducted an investigation with the House Oversight and Reform Committee, chaired by Representative Carolyn Maloney (D.-NY). In a statement, she said she hopes the report will be “a wake-up call for the FDA to reform its practices and a call to action for my congressional colleagues to continue to monitor oversee the pharmaceutical industry to make sure they don’t put profits above patients.” .”