FDA drug, device postmarket programs to be audited by GAO at Rep. Wyden's request.

Executive Summary

FDA DRUG, DEVICE POSTMARKET SURVEILLANCE PROGRAMS TO BE EXAMINED BY GAO at the request of Rep. Wyden (D-Ore.). General Accounting Office staffers say an initial meeting on the audit with personnel from the agency's device and drug centers is scheduled for the week of May 1. In an April 12 letter, Wyden asks GAO "to assess the scope and adequacy" of FDA's device and drug post-market surveillance programs. The study also is to include "an examination of the extent to which FDA is able to monitor other countries' experience with newly approved pharmaceuticals, and translate that information into findings and appropriate actions protecting U.S. consumers."