The Coming Collision of Ethics and the FDA: The Looming Problem of Cognitive Enhancement

Abstract

The current FDA process is not well suited for the introduction of enhancement drugs that are intended to improve certain aspects of cognition or behavior to a degree beyond what is normal. Even though there are no statutory restrictions against approving these drugs, the current positioning of the FDA approval process suggests these types of drugs would have a difficult time receiving approval for an indication that covers normal, healthy adults. However, until now the FDA has not had to confront this issue directly, since despite common media hype there is little scientific evidence that any drugs are true cognitive enhancers. That said, scientific interest in this area is growing, as is the pace of understanding about the framework of the brain. It seems only a matter of time before potently effective cognitive enhancements are developed. Once this happens, the current FDA norm of approval for a specific indication, followed by large off-label use, could result in many important ethical and safety questions going unaddressed. Ultimately, if the FDA is going to satisfy its mission to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner,” a new framework will need to be developed.