On July 9, the current acting FDA Commissioner Janet Woodcock called for the Office of Inspector General to investigate the agency’s close ties with Biogen who had submitted its Alzheimer’s drug, Aduhelm for FDA approval. For those of you not familiar, the Office of Inspector General has the authority and power to subpoena internal FDA documents and interview staff under oath for matters related to the safety or efficacy of a drug or medical device that was approved by the FDA and to investigate its practices. Currently the OIG is in the process of investigating several of the FDA’s internal review processes.

The OIG will conduct an independent review into meetings between FDA officials and representatives of Biogen that occurred just before the agency approved a controversial Alzheimer’s drug.

Janet Woodcock said, “I have tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Leadership,” there continue to be concerns raised, however, regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process... I believe that it is critical that the events at issue be reviewed by an independent body.”

Aduhelm, a monoclonal antibody for the treatment of Alzheimer’s disease, was extremely controversial when it was first approved due to concerns that it may not be effective in treating patients. Indeed, critics said that there was no real scientific evidence that the drug helps delay the progression of Alzheimer’s disease. Additionally, Aduhelm isn’t cheap- It’s an estimated $56,000 and that could impact Medicare services.

On the other hand, patient advocacy groups and Biogen senior executives say that the drug demonstrates the removal of a brain protein seen in Alzheimer’s patients, and could be approved on that basis alone. Albeit, several products have been approved historically by the FDA based on biomarker data such as is the case with Aduhelm. For example, Crestor, a well-known cholesterol lowering drug, was improved without any hard outcomes as was Lipitor when they were originally launched based on the class effects of previous statins such as Zocor. The FDA initially approved Aduhelm for use in any Alzheimer’s patients, and had requested that Biogen continue to monitor patients (Real World Evidence) to collect data ensuring that the medication has significant efficacy in Alzheimer’s patients.

Nevertheless, on July 9, 2021, the FDA revised its recommendation indicating that Aduhelm should only be used in patients with mild-Alzheimer’s disease. The crux of the concern hedges on interactions in May 2019 between Biogen Executive, Dr. Al Sandrock, and Dr. Billy Dunn who is the FDA’s head of neuroscience. The two had meetings outside of the formal review process regarding the data as well as the FDA agreeing to present data in conjunction with Biogen on Aduhelm- which isn’t customary practice.

Approximately, over 5.8 million Americans are living with Alzheimer’s disease according to the CDC and that number is expected to grow. Parkinson and Alzheimer’s have been difficult to treat and physicians do not have a lot in their toolbox to help patients. May key opinion leaders (KOLs) in the Alzheimer’s space were excited at the potential of Biogen’s new drug to help their patients. As the OIG continues its investigation, it is likely that more questions will be raised about ways to ensure that interactions between regulators and pharmaceutical manufacturers are ethical and do not influence the FDA review process.