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HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

The U.S. health department’s inspector general will review how the Food and Drug Administration grants accelerated approvals of new drugs, announcing a broad investigation Wednesday after two months of scientific controversy over the agency’s June decision to clear Biogen’s Alzheimer’s drug Aduhelm.

The FDA’s own leader had called for a federal review last month in response to reports detailing unusual aspects of the close collaboration between the agency and Biogen in assessing clinical trial evidence for the medicine. In a July 9 letter, Acting Commissioner Janet Woodcock asked the Health and Human Services inspector general to examine contacts between FDA staff and Biogen representatives during the decision-making process that led to the approval.

But the plan disclosed by the inspector general Wednesday appears to go further and will assess the FDA’s use of the accelerated approval pathway more broadly.

“This will include reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” the inspector general said in a statement. The review will be based on a “sample of drugs” that were cleared under accelerated approval, including Aduhelm.

The inspector general said it won’t make any determination, however, regarding the “scientific appropriateness” of any approval made by the FDA.

In a statement on Twitter, Woodcock said the FDA will cooperate with the investigation. “Should the HHS OIG identify any actionable items and provide the agency with any recommendations, the FDA would review those expeditiously to determine the best course of action,” she wrote.

Any outcome will be some time in coming, though. The inspector general plans to complete its investigation in fiscal year 2023, which begins for the federal government on October 1, 2022. The review may also result in multiple reports, the inspector general said.

The investigation will follow what’s become one of the most controversial approvals in the history of the FDA.

Typically, the agency looks for multiple large clinical trials to generate positive results before it clears a drug for market. But with Aduhelm, the two trials that were supposed to show it can slow the cognitive decline associated with Alzheimer’s had starkly different outcomes. One trial succeeded, according to Biogen, while the other found patients given Aduhelm actually did worse than those on placebo. The contradictory data and the ways in which Biogen analyzed them led the FDA’s own statisticians and advisors to conclude there wasn’t enough evidence to approve the drug.

And yet, the FDA still did. The agency gave Aduhelm the greenlight on June 7 and granted it a surprisingly broad label with little restriction as to who, among an estimated 6 million Alzheimer’s patients in the U.S., was eligible to receive it. After considerable pushback, the FDA later revised the label to recommend doctors treat patients with mild dementia.

The approval itself wasn’t the only point of contention. It had become apparent, in the months leading up to the FDA’s decision, that the agency had worked closely with Biogen during its review process. Recent reports, though, detail just how unusual the relationship was. According to STAT, an off-the-books meeting in 2019 between a top Biogen official and the head of the FDA unit that evaluates new brain drugs laid the groundwork for “Project Onyx,” a secretive Biogen initiative to get Aduhelm approved.

Amid intense scrutiny, Woodcock asked for an investigation into Aduhelm’s review. Though she has avidly defended the agency, Woodcock recently acknowledged in an interview with STAT “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved.”

Public Citizen, an advocacy group that called for Woodcock and other FDA officials to resign following the Aduhelm approval, said in a statement Wednesday the inspector general review was “long overdue.”

According to a recent report in The New York Times, letters Public Citizen sent the agency in December 2020 and January 2021 led the FDA to conduct its own internal review this spring of the agency’s collaboration with Biogen.