FDA Leaders Stress Science and Compliance

The new leadership at the US Food and Drug Administration is wasting little time in taking steps to make the agency more efficient and effective. The FDA is announcing new rules and policies almost daily and strengthening enforcement of manufacturing and marketing requirements to show the industry it means business.
FDA Commissioner Margaret Hamburg began by reorganizing her immediate office to emphasize the importance of food safety and scientific integrity and to encourage speedy compliance with rules. An expanded office of external affairs will improve communications with the media, health professionals, and special interest groups. Several crosscutting activities—bioresearch monitoring, combination products, orphan drugs, and pediatrics—will be managed by a new Office of Special Medical Programs.

Budget development will shift to the policy office to better explain to Congress how the FDA spends its resources and why it may need additional funding. Hamburg is benefiting from a record $3 billion budget for the coming year (including some $600 million in user fees) but will be hard-pressed to further expand resources.