The Food and Drug Administration (FDA) has come under fire from House Democrats following an investigation which revealed close cooperation between the agency and Biogen (NASADQ: BIIB), the sponsor of the Alzheimer's drug Aduhelm.

The investigation, led by the Oversight and Reform Committee and the Energy and Commerce Committee, found that the FDA held an unusual number of meetings with Biogen and even co-authored a briefing document presented to outside advisers.

Despite the agency's preliminary approval of Aduhelm in 2021, Medicare officials refused to cover it, effectively dooming the company's profits.

FDA Commissioner Robert Califf defended the agency's decision, stating that "nobody's in trouble," and acknowledging that mistakes were made in failing to properly document all interactions with Biogen. He went on to say that Billy Dunn, the agency's neuroscience leader, made the right call in working closely with Biogen to reconsider the company's data after they halted their trials.

Dr. Califf also argued that a high level of interaction between agency officials and drug companies helps to cut down on applications for drugs that don't work and waste investment. He stated that in every clinical trial, there will be questions about how to interpret the data, and the way to resolve these issues is through discussions and joint examination of the data.

The investigation also revealed that the FDA and Biogen pursued a broad label for Aduhelm, indicating that it was intended for all Alzheimer's patients, even though clinical trials had been limited to a smaller subset of patients. The label was later narrowed.

The FDA recently granted accelerated approval to Leqembi, developed by Eisai Co. and Biogen, which also targets amyloid plaque in the brain, thought to be key in slowing the progression of Alzheimer's disease. The agency is expected to make a decision on Eli Lilly & Co.'s donanemab, another Alzheimer's drug, in the coming months.

Overall, while the investigation revealed some concerns about the level of cooperation between the FDA and Biogen, Commissioner Califf maintains that the agency's decision to approve Aduhelm was the correct one, and that the overall goal of working closely with drug companies is to promote the development of effective treatments for diseases like Alzheimer's.