Hamburg pushes science, enforcement in FDA strategy
A regulatory environment driven by developments in science and technology is high on Margaret Hamburg's list of strategic priorities. She considers herself an advocate for the field of regulatory science and a champion of its evolution.
The FDA yesterday released the 50-page Strategic Priorities 2011 - 2015: Responding to the Public Health Challenges of the 21st Century. The document identifies five "cross-cutting areas," including regulatory science. The remaining four target safety in the global supply chain; stronger compliance and enforcement activities; greater attention to such special populations as women, minorities and children; and emergency medical countermeasures.
Regarding compliance and enforcement, the document recaps recent FDA changes, including deadlines for warning letter responses and the means to prioritize post-warning-letter/post-recall follow-up plant inspections. New programs will "sharpen the effectiveness and timeliness of regulatory, compliance and enforcement systems."