Clinical Research Under Scrutiny

The Food and Drug Administration is stepping up oversight and enforcement activity for medical products, including the conduct of clinical trials. There are more warning letters going to investigators, and institutional review boards (IRBs) are under scrutiny following the recent exposé of lax reviews. Sponsors feel pressure to monitor studies more carefully and to fully disclose clinical trial activity and study results in public databases.

"Enforcement will increase," warned Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER), at the April annual meeting of the Food and Drug Law Institute (FDLI). She pointed to a rise in injunctions, investigator disqualifications, and warning letters and advised companies to avoid the big stick by "being proactive about compliance."

This emphasis reflects the attitude of FDA's new leadership. Principal deputy commissioner Joshua Sharfstein, who was acting commissioner until Margaret (Peggy) Hamburg was confirmed to the top spot in May, made it clear that a new sheriff is in town. Soon after coming to FDA in March, Sharfstein initiated a fast and more aggressive recall of pistachio products at the first sign of salmonella contamination. He also responded to criticism of FDA's process for regulating medical devices by supporting a review of research requirements for device classes.