FDA commissioner Andrew von Eschenbach on Jan. 30 unveiled a comprehensive series of steps now being undertaken in direct response to last September’s Institute of Medicine report that sharply criticized the FDA’s drug safety program and that recommended changes to the nation’s drug safety system.
“We find we are in substantial agreement with most of the IOM recommendations,” von Eschenbach said. “The initiatives we are announcing today are not just a plan, but a real pathway to enhanced drug safety.”
The IOM report, requested by the FDA in 2005 in the wake of safety problems with Vioxx and other medications, was delivered to the agency last September.
Von Eschenbach said a “transformation” of FDA’s drug safety system will be accomplished by undertaking changes in three critical areas: by strengthening the science that supports the medical product safety system; by improving communication and information flow among health care providers and consumers; and by making certain improvements to internal agency operations and management.
Specific activities include development of new scientific approaches to detecting, predicting and preventing adverse events and new quantitative tools to assess benefits and risks associated with drug use; formation of a new advisory committee to recommend improvements to the agency’s risk communication policies and practices; and development of a new pilot program to assess the utility of postmarketing evaluations for routine new molecular entities.
From the March 01, 2007 Issue of MM+M - Medical Marketing and Media
