On April 24, at the Food and Drug Law Institute’s (“FDLI’s”) 55th Annual Conference 2012, reflecting on history of the FDA and FDLI, FDA Commissioner Margaret A. Hamburg, M.D., noted that dating back to the first FDLI/FDA informal conference back in 1957, FDA continues to regulate an “enormous scope” of products with a continuing need for more resources. Hamburg said that FDA is now at a “turning point”–there is a need to develop medical countermeasures for biological threats either natural- or terrorism-oriented, such as new antibiotics, and there are needs for new product such as treatments for type II diabetes and obesity. At the same time FDA is poised for various riders expected to be added to the four user fee bills presented to Congress. Some of those riders include new provisions for accelerated approval, increased authorities for FDA to regulate products or component of products made overseas (e.g., 85% of the active ingredients are manufactured outside us and 40% drug products are made outside the United States), increased monitoring for drug shortages, and strengthening FDA’s rare disease program. Hoping to create a “brand” for FDA, Hamburg said there is a need for stronger and more sophisticated science to help bolster reliance by the world on FDA’s decision-making as the “gold standard.”
Following Hamburg, three of FDA’s relatively-new Deputy Commissioners discussed key issues confronting each of them. Michael R. Taylor, Deputy Commissioner for Foods, said that he believes resource allocation is important. Taylor’s key issues include antimicrobial resistance, nutrition labeling, nanotechnology, chemical contaminants, a new strategic plan for foods and veterinary medicine, and executive leadership management–all with a need to involve stakeholders in the process. Stephen P. Spielberg, M.D., Deputy Commissioner for Medical Products and Tobacco, said that he is excited to be working at FDA at a time when the medical community is better understanding the causes of diseases. He is looking at the potential for more synergies between the centers and also looking at his own responsibilities, including how to help prevent children from initiating smoking and becoming addicted to nicotine. Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, said she is interested in “leap frogging” and developing an enterprise management where domestic and foreign inspection are handled the same in an increasingly global environment with statutes and regulations drafted with domestic manufacturing primarily in mind. Autor is hoping that manufacturers take a better look at the supply chain and components that go into their products, while developing better risk analytics to maintain quality.
Following a discussion on FDA regulatory science and a lunch session highlighting FDLI’s new upcoming conference in Brazil, each of the FDA centers presented their outlooks for the upcoming year. Presenting for the Center for Drug Evaluation and Research (“CDER”), Deputy Center Director, Douglas C. Throckmorton said that a key priority will be to finalize and implement the requirements of FDA’s requested user fees. CDER plans to fill a number of key senior leadership position: an additional Deputy Center Director and directors for the Office of Generic Drugs, the Office of Biostatistics, the Office of Clinical Pharmacology, and the Office for Surveillance and Epidemiology. In addition,