As one of her first initiatives after being sworn in as FDA Commissioner, Dr. Jane Henney established a Task Force to evaluate the system for managing the risks of FDA-approved medical products, focusing particularly on FDA's part in the system. This report is the result of that review.
Briefly, the Task Force assessed risk management practices within the overall healthcare delivery system, focusing on the roles and responsibilities of each participant. The Task Force applied a risk management model used in other Federal sectors. We also examined the various risks from medical products and their sources. The Task Force then evaluated FDA's role in the current system. First, we reviewed the Agency's premarketing risk assessment and approval processes to determine if serious adverse events are occurring at a higher rate now than they have in the past. Next, the Task Force evaluated FDA's postmarketing surveillance and risk assessment programs to see if they are doing the job they were intended to do. Finally, the Task Force analyzed all of FDA's risk management activities to evaluate the Agency's role in the overall system for managing medical product risks. Our findings are summarized here.