In response to a September Institute of Medicine report and ahead of the anticipated introduction of legislation calling for its overhaul, the Food and Drug Administration released a report detailing how it will put IOM recommendations into place to ensure the safety of drugs and medical devices it regulates.
FDA officials promised a new commitment to safety and a pledge to work with the Veterans Health Administration to share information on drug and device safety. Their report also noted the importance of improving communication and information flow, and announced the formation of an advisory committee on communications.
FDA Deputy Commissioner and Chief Medical Officer Janet Woodcock noted how the new approach will make better use of new science and technology and how a new understanding of "the molecular mechanisms of adverse events" will allow for the screening of harmful compounds so they never get put into drugs in the first place or will help identify those who are most at risk from a negative reaction to those compounds. This approach, she said, will allow the FDA to go from just counting side effects of new drugs to actually preventing and controlling them.
Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said the agency's MedWatch system for postmark drug-safety surveillance -- which has been criticized as a passive and cumbersome program -- will be updated and its data will be more accessible to researchers and the public. He added that the FDA will launch a pilot program to evaluate various ways of assessing the safety of new products on the market and that it also plans to begin publishing a newsletter on postmarket drug reviews this year.
Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) are expected to introduce a bill to overhaul the FDA's drug safety operations, and Kennedy released a statement indicating that the FDA's actions won't alter his course.
"Today's report is thoughtful and provides important recommendations for administrative action, but only legislation can give FDA the tools it needs to ensure that the agency is the gold standard for safety," the statement said.