Agency Plans Changes in Drug Safety System
Citing the need to keep pace with the technological transformation of medicine, the FDA has outlined a set of new initiatives to strengthen its medical product safety system. The changes are in response to recommendations issued last year by the Institute of Medicine (IOM).
FDA agreed with the IOM that it needs “to balance expeditious access to drugs with concerns for safety” (IOM, Sept. 2006).
Planned steps include establishing a new advisory committee on risk communications, introducing a pilot program to assess the utility of postmarketing evaluations for routine new molecular entities, and implementing an electronic safety tracking system.
“Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology, and the health-care system,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, MD. Simultaneously, FDA announced that it has signed an interagency memorandum with the U.S. Veterans Health Administration to share information related to the review and use of FDA-regulated medical products.
FDA's “The Future of Drug Safety” report can be found at http://www.fda.gov/oc/reports/iom013007.html.