Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug

WASHINGTON — Former health secretary Donna Shalala called for a federal investigation into the Food and Drug Administration’s polarizing approval of a Biogen treatment for Alzheimer’s disease, citing STAT’s revelation Tuesday that regulators were far more closely aligned with the company than previously disclosed.

“When you see a report like this, you have to investigate it,” said Shalala, a former member of Congress who led the Department of Health and Human Services under President Clinton. “You cannot hesitate and you can’t do it with your general counsel. You’ve got to send in the Office of Inspector General. I mean, you shouldn’t hesitate for one second.”

Shalala joins a chorus of advocates and academics demanding answers on the close relationship between Billy Dunn, head of the FDA’s neuroscience division, and Biogen executives in the run-up to the approval of the drug, called Aduhelm. Public Citizen, the progressive advocacy group founded by Ralph Nader, cited the STAT reporting in a renewed call for an OIG investigation, as did Yale University public health professor Gregg Gonsalves.

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The Office of Inspector General is the health department’s independent investigations arm. It has sweeping powers, including the use of subpoenas and interviews under oath to investigate allegations of “possible violations of law, regulation, or policy” by government employees, or companies that interact with the government, like doctors offices accused of defrauding Medicare. OIG, should it find wrongdoing, can recommend a host of disciplinary actions, including monetary penalties and firing, though it is up to the HHS Secretary whether to follow those recommendations. The OIG can also refer criminal cases to the Department of Justice, although neither Public Citizen nor Shalala have alleged any criminal wrongdoing by the FDA.

The biggest benefit of an OIG investigation, according to Shalala, is the OIG’s independence from the HHS secretary. The OIG independently decides when to initiate an investigation, and those investigations cannot be stopped by the HHS secretary. They also have express power to communicate their findings directly to Congress.

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“The secretary can’t hide the report,” Shalala explained.

But external pressure alone can’t force the OIG into action, said Stewart Kameen, an attorney at Bass, Berry & Sims who previously worked for the HHS OIG.

“There’s certainly a lot of momentum for an investigation, or an audit, or a review,” Kameen said of the Biogen situation. But “having worked there, I was always very impressed by the sincerity with which they took their independence to heart,” he said.

A spokesperson for OIG said in a statement that it had received Public Citizen’s letter calling for an investigation and is “reviewing it for appropriate action.”

STAT reported that Biogen had an off-the-books meeting with Dunn in May 2019, enlisting his support for the treatment that would become Aduhelm. A month later, Dunn and his FDA colleagues proposed using a regulatory shortcut called accelerated approval to get the drug approved, contradicting the agency’s claim that it raised that option only this past March. The FDA was so supportive of Aduhelm that, even in 2019, some inside Biogen believed its approval was inevitable.

Public Citizen has also called for the firing of three top FDA officials at the center of the Biogen scandal: acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research Director Patrizia Cavazzoni, and Dunn.

Shalala stopped short of also endorsing their firing.

“You’ve gotta get the facts first,” Shalala said. “And your law enforcement in the department is the OIG.”

The FDA declined to comment on STAT’s reporting. Biogen, given a list of detailed questions, said only that the company respects and followed the FDA’s guidance throughout the development of Aduhelm.

Last week, two members of Congress announced an investigation into the FDA’s approval of the drug and Biogen’s decision to set a list price of $56,000 a year.

Rachel Cohrs contributed reporting. 

Source: STAT