TThe chief of the Food and Drug Administration has called for a broad federal inquiry into the approval of Biogen’s treatment for Alzheimer’s disease just one month after a move that angered lawmakers, doctors and advocates for Alzheimer’s disease. public health.
In a letter released Friday, Acting Commissioner Janet Woodcock asked the Independent Office of the Inspector General to investigate how agency staff interacted with Biogen in the run-up to Aduhelm’s approval on June 7. The agency cited the STAT report that FDA officials worked hand-in-hand with Biogen executives to bring the drug to market, including an informal meeting and an unprecedented decision to approve Aduhelm via a regulatory shortcut.
“Concerns continue to be raised… regarding contacts between Biogen and FDA officials during the review process, including some that may have taken place outside of the formal correspondence process,” Woodcock wrote in a letter to Acting Inspector General Christi Grimm. “To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is essential that the events in question be reviewed by an independent body such as the Office of Inspector General to determine if any interactions that occurred between Biogen and FDA review staff did not comply with FDA policies and procedures.
Woodcock added that she had “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and in their commitment to unbiased decision-making. and science-based “.
The STAT reports prompted calls for an OIG investigation from advocacy groups, former federal health officials and members of Congress.
Inspector General investigations are among the most serious types of civilian investigations that can be conducted in a federal agency. The Office of the Inspector General generally has broad power to subpoena internal FDA documents and to conduct interviews under oath. The OIG can also report potential criminal offenses to the Department of Justice. However, no allegations of criminal conduct have been made against the FDA.
Rarely does the OIG investigate the FDA, and even more exceptionally, does it investigate an individual drug approval decision, according to STAT’s public record review. The Inspector General is currently reviewing a number of FDA programs, such as its medical device safety surveillance systems, although the majority of these investigations are audits and evaluations, less serious forms of investigation.
“There should be an investigation, and it should be broad and not limited to the inappropriate relationship between the FDA and Biogen,” said Gregg Gonsalves, a professor at the Yale School of Public Health who strongly criticized the approval of Aduhelm. . “We need to know in more detail how the decision-making was made within the agency, because it was such a departure from the normal procedure.”
Given the constant interest and questions, I asked today that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and the FDA during the process leading to Aduhelm’s approval. pic.twitter.com/iWJNxdZ5Cs
– Dr Janet Woodcock (@DrWoodcockFDA) July 9, 2021
The OIG operates independently of any federal agency, and Woodcock’s letter does not guarantee that the office will conduct an investigation. If the OIG chooses to investigate Aduhelm’s approval, it will eventually publish its findings in a public report.
Previous calls for an OIG investigation have focused on the close relationship between Billy Dunn, head of the FDA’s neuroscience division, and executives at Biogen. Earlier this month, STAT reported that Biogen had an informal meeting with Dunn in May 2019, seeking his support for the treatment that would become Aduhelm. A month later, Dunn and her colleagues at the FDA proposed using a regulatory shortcut called Fast Track Approval to gain approval for the drug, contradicting the agency’s claim that it only raised that option. last March. The FDA was so supportive of Aduhelm that, even in 2019, some members of Biogen believed its approval was inevitable.
This week, two senior FDA officials told STAT they were surprised the agency chose to approve Aduhelm for all people with Alzheimer’s disease, rather than restricting it to those who match the patients in clinical trials of the drug. One said he would not have supported the drug’s approval if he had known the FDA would give it such broad approval.
Biogen’s treatment, intended to tackle the underlying cause of Alzheimer’s disease, has polarized scientists for years. The company has conducted two large clinical trials to prove the benefits of Aduhelm. In one, the drug appeared to slow the progression of Alzheimer’s disease compared to placebo. In the other, Aduhelm failed and the highest dose of treatment was worse than saline.
As of 2019, the FDA worked closely with Biogen to demonstrate that, taken as a whole, the data suggests that patients who receive a high dose of Aduhelm for an extended period of time see a measurable benefit on cognition tests. and function. The resulting approval, which overcame objections from independent FDA advisers, has spawned allegations of inappropriate conduct and regulatory overshoot.
“It would be really important to understand what happened and what kind of relationship may have influenced the decision,” said Steven Joffe, professor of medical ethics and health policy at the Perelman School of Medicine. “It appears that an independent investigation, which the OIG could do, would be good for the public and stakeholders to understand the context behind the decision.”
A former FDA official said an investigation could actually help steer Woodcock away from Aduhelm’s controversial decision. The agency’s longtime veteran is currently its acting commissioner, but she is one of the top contenders for nomination for the full role. The official pointed out that while Woodcock was not involved in the approval decision, it was made by people she had elevated to decision-making roles.
“In view of the controversy surrounding the decision and all the irregular actions that have been taken, a review by the Office of the Inspector General is certainly warranted, given all the irregularities in the context of previous decisions taken by the agency, ”said Joseph Ross, professor of medicine and public health at Yale. “I just hope that the investigation takes place in a timely manner and that the findings are made public so that we can learn from them.”