The FDA plans to spend $2.35 billion, part of which will go toward ramped up food and dietary supplement safety enforcement efforts. The approval comes just two weeks after the FDA was criticized by the U.S. Government Accountability Office (GAO), a congressional watchdog group, for its failure to accurately forecast its budget needs.
The GAO report noted that a disproportionate amount of the budget was being devoted to the premarket approval of drugs, while much less was being devoted to tracking product safety in the marketplace. The report also noted that the FDA was not able to accurately track the number of adverse event reports (AERs) it reviewed, making it difficult to allocate resources properly. Additionally, between 2004 and 2008, the FDA failed to inspect all U.S. drug manufacturing plants, as required by law. “This report makes it clear that the FDA has to get a handle on its own resource requirements and how to use resources more effectively,” said Iowa Senator Charles Grassley.
The Senate bill is similar to the $123.8 billion bill passed by the House of Representatives on July 9. The two versions of the budget will be reviewed by a House-Senate negotiating panel before being submitted to both chambers for another vote, according to Bloomberg.
FDA Commissioner Margaret Hamburg acknowledged that there have been problems with the FDA’s enforcement efforts during a prepared speech in front of the Food and Drug Law Institute (FDLI) on August 6. “Reports have noted that there has been a steep decline in the FDA’s enforcement activity over the past several years. In some cases, serious violations have gone unaddressed for far too long,” Hamburg said. “The pathways for enforcement action can be too long and arduous when the public’s health is in jeopardy. We are fixing these pathways to improve the effectiveness of our enforcement system.”
Hamburg detailed five specific procedural changes that will help with enforcement efforts. First, the FDA will set post-inspection deadlines to ensure corrections are made promptly. Second, the warning letter system has been streamlined to allow for those to be sent out faster. Third, the FDA will work more closely with local and state regulatory partners that often have more authority to take action quickly. Fourth, the FDA will prioritize enforcement follow-up to ensure that companies are making the required changes in a timely manner. Finally, the FDA will no longer issue multiple warning letters to noncompliant firms. Instead, Hamburg said the FDA is prepared to act “swiftly and aggressively to protect the public.”
The dietary supplement industry has been quietly abuzz over the last 12 to 16 months regarding the FDA’s increased enforcement efforts. Companies have been painstakingly undergoing dietary supplement GMP inspections and trying to get a better feel for a suddenly rejuvenated FDA. Hamburg’s speech marks the first time under the new administration that the FDA has stated in no uncertain terms that enforcement efforts are increasing. Funding has increased, staffing has increased, the commissioner has narrowed the focus and the FDA is ready to play hardball.
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