FDA’s Paul Seligman Answers Some Questions About The Agency’s Drug Oversight Performance

(Posted by Tom Lamb at DrugInjuryWatch.com)

Paul Seligman, M.D., M.P.H., is Associate Director of Safety Policy and Communication in FDA’s Center for Drug Evaluation and Research. 

On May 31, 2007 the FDA posted on its web site a Question-and-Answer session with Dr. Seligman regarding how the agency is trying to manage the drug safety issues it has confronted in recent years.  In particular, Dr. Seligman answers this set of questions:

1. Why would FDA approve a drug if it has risks?
2. What factors does FDA consider when weighing a drug’s benefits and risks?
3. Why do some safety issues arise after a drug has already been approved for marketing?
4. Where do post-marketing safety reports come from?
5. What kind of action does FDA take after receiving post-marketing safety reports?
6. What if FDA is faced with conflicting drug safety data?
7. Why does FDA inform the public about a potential safety issue if the agency is still weighing evidence?

On May 31, 2007, also, the FDA posted on its web site a piece entitled "Strengthening Drug Safety" which includes the agency’s current positions on the following subjects:

• Strengthening the Science
• Improving Communication
• Communications Advisory Committee
• Improving Operations and Management
• Headlines, Hoopla, and Drug Safety

We will continue to monitor and report how the FDA is handling its mandate to ensure the safety of prescription drugs used by patients in the U.S.