In recent years, Congress has called on the agency to regulate food quality more closely and to monitor tobacco marketing, while continuing to ensure the safety, quality, and efficacy of medical products. The result is a top-level reorganization that shifts daily management and decision-making to others, permitting the commissioner to focus more on crucial scientific and policy issues.
Another new deputy commissioner for global regulatory operations and policy, Deborah Autor, will manage FDA's Office of International Programs and the Office of Regulatory Affairs, which runs the agency's far-flung field force. This force includes FDA foreign offices, which have been established around the world to support oversight of an expanding volume of food and medical products imported into the United States. Autor is quite familiar with supply-chain vulnerabilities and difficulties related to surging imports. She previously headed the Office of Compliance (OC) within the Center for Drug Evaluation and Research (CDER), which also has been overhauled.
The explosion in foreign production of FDA-regulated products requires more collaboration and information exchange with established regulatory counterparts, according to Autor. "We can never get enough resources to cover all those facilities," she told the PDA–FDA Joint Regulatory Conference in September 2011. Autor also seeks to level the playing field between US-based and foreign manufacturers by gaining authority to block drugs from US markets if their producers limit or refuse FDA inspection or fail to comply with US quality standards. Autor anticipates further assessment of these approaches in a consensus study by the Institute of Medicine (IOM) on the global public health risks from substandard, falsified, and counterfeit medical products.
And Chief Scientist Jesse Goodman continues to lead important regulatory science initiatives. Goodman's office oversees the National Center for Toxicological Research, counterterrorism and threats, and professional development and integrity for FDA professionals. Special offices for women's health and for minority health fall under Goodman's purview, but also report to Hamburg.