Molecular Medicine News Analyses

In the Press:

FDA responds to the Institute of Medicine Report

In September 2006, the Institute of Medicine (IOM) delivered a report on the state of the Food and Drug Agency’s (FDA) drug safety procedures. In response to the IOM report, which the FDA solicited, FDA Commissioner Dr. Andrew von Eschenbach outlined FDA’s improvement plan on January 30, 2007.

Although the majority of the press coverage focused on the implementation of post-marketing surveillance (e.g., a formal 18 month review after approval), the improvement plan outlines a series of unprecedented steps to incorporate pharmacogenomics into the drug decision process itself. In doing so, the FDA is revitalizing its internal scientific capabilities, which have declined (by FDA’s own statements) during years of restricted funding and insufficient resources.

The FDA response, entitled “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” outlines a series of steps that recognize and promote the growing importance of molecular medicine in guiding safety studies, both of current drugs as well as new compounds in the development pipeline.

In its report, the FDA notes that “improving our communication and information flows will further strengthen the effectiveness of the drug safety system.” In particular, they recognize that in order for communications to be effective they must be expanded to incorporate all stakeholders across the healthcare spectrum.

Harris, Gardiner. (January 31, 2007). F.D.A. Widens Safety Reviews on New Drugs. New York Times. http://www.nytimes.com/2007/01/31/washington/31fda.html