by Wayne Pines
The need for FDA to have increased resources and to enhance its post-marketing surveillance system for drugs were the two themes emphasized by speakers at the FDAAA annual dinner Sept. 30 at Normandie Farms restaurant in Potomac, Md. About 90 people attended the dinner, which was held at Normandie Farms for the first time.
Former Commissioner Frank Young, M.D., Ph.D., spoke briefly about the need for FDA to have the resources it needs to do its job. Young said FDA has been chronically under-funded but its thousands of dedicated employees are nevertheless expected to fulfill their responsibilities with diminishing resources.
Jonathan Javitt, M.D., M.P.H., discussed the recent Institute of Medicine report that was critical of FDA for its management of drug safety issues. He said that technology exists to create a database system for monitoring drug safety much more efficiently and accurately. The challenge, he said, is that FDA has little authority to require post-marketing surveillance and does not have the money to implement a nationwide surveillance system.
Dr. Javitt just finished as a presidential appointee chairing the Health Subcommittee of the White House Information Technology Advisory Commission. He is a Johns Hopkins professor and senior fellow at the Potomac Institute for Policy Studies.
Young and Javitt were substitute speakers for Acting Commissioner Andrew von Eschenbach, M.D., who was unable to attend the dinner due a family emergency.
The dinner was organized by Fredda Valenti, Anne Marie Finley and Andrea Chamblee from the FDAAA Activities Committee.
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