Friday, August 07, 2009 by Lee Mannering
FDA announces new vision for regulation enforcement
Yesterday FDA Commissioner Margaret Hamburg presented a new vision for enforcement of the Food and Drug Administration regulations and rules in support of public health. In her announcement, she highlighted six initial steps designed to hone the effectiveness and timeliness of the FDA’s regulatory and enforcement system. Some of the steps address inspection documentation and processes, while others focus on agency coordination and communication. She also said that FDA will work more closely with the agency’s regulatory partners at the federal, state, and local levels to take rapid action.
In our recent comments to FDA on the agency’s transparency efforts, we called on FDA to work more transparently with state/local agencies to improve best practices, identify gaps in capability and capacity, and speed communication among all agencies. Dr. Hamburg’s announcement reinforces the thought that broader information sharing will help industry and government work swiftly toward the same goal – protecting public health.
August 7th, 2009 at 9:53 am
I find it interesting, and somewhat revealing, when Dr. Hamburg speaks to greater enforcement activities and it is about writing letters. Even more revealing is the absence of comments about the Bioterrorism Act of 2002 and any enforcement enhancement: including letters.
The Bioterrorism Act of 2002 is the strongest food law established since the 1930s and gives extraordinary enforcement capabilities to the FDA.