Oral

After numerous reports of safety concerns and several withdrawals of medications from the U.S. market, federal legislation was enacted last year to change the structure and improve the safety oversight of the FDA. The Food and Drug Amendments Act of 2007, or FDAAA, included a number of provisions that address safety concerns throughout a drug's life cycle. The FDAAA mandates that the agency conduct post-marketing surveillance and develops new quantitative tools to assess and manage drug benefits and risks. As part of the implementation process, the FDA is proposing a 5-year safety modernization plan which will include the improvement of these methodologies to maximize public health protections. New public health training programs will be needed, as will efforts to improve drug safety information and communication. Some question whether these efforts can succeed without many more resources, while others are concerned that there remains a conflict in the FDA's roles of approving drugs for marketing and of monitoring drugs for safety. This session will include speakers from the FDA, the pharmaceutical industry and academia who will address the content of the legislation and its implications for patients and the public health community.

Session Objectives: Recognize the major elements of the recent federal legislation to reform the FDA and improve drug safety in the U.S Understand the new methodologies developed to assess and communicate risk and benefts of drugs. Identify the role of physicians and public health practitioners, the public, and the pharmaceutical industry in promoting drug safety.

CE Credits: CME, Health Education (CHES), Nursing