(KERO) — The approval of an Alzheimer's treatment may not have followed standard approval procedures.
An 18-month investigation by the House Oversight and Reform Committee found "atypical collaboration and interactions" between the Food and Drug Administration (FDA) and the drug's manufacturer, Biogen.
Investigators switched to consider the drug under its Accelerated Approval Program. This allows the FDA to approve certain drugs that both meet "an unmet medical need" and "treat serious conditions."
Investigators found during that process, FDA and Biogen officials communicated more than 115 times, which the investigation report says the FDA admitted "exceeded the norm in some respects."
