THURSDAY, Dec. 29, 2022 (HealthDay News) — The U.S. Food and Drug Administration approval process for the controversial Alzheimer 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 revealed.

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 for 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 approval process for Aduhelm? According to the report, an unusual arrangement called a “collaborative workstream” began in July 2019. 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. During 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.

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.

The New York Times Article

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