Oral

The public health community has been actively engaged in improving pharmaceuticals safety in the US. A 2006 APHA policy statement recommended FDA and system reform. This session addresses recent reform proposals from the Institute of Medicine (IOM) by engaging represenatives from Congress, the FDA, the industry, in a dialogue on the public health implications of these proposals. The IOM committee's report, The Future of Drug Safety – Promoting and Protecting the Health of the Public recommended improvements in drug review, safety surveillance, and related activities of the FDA Center for Drug Evaluation and Research (CDER). After releasing the report, the FDA and Pharmaceutical Industry urged that drug review fees under the Prescription Drug User Fee Act (PDUFA) be increased to pay for improved FDA capacity to monitor drug safety during a drug's lifecycle. Many critics consider this response inadequate and have made additional proposals. These proposals have been the subject of legislation debated in Congress. Controversial issues include whether a new drug safety center should be created, and whether this center should be inside the FDA or independent of CDER's drug review and approval process. Other reform recommendations included mandating more disclosure of clinical trial data, giving FDA the authority to order rather than negotiate new labeling changes, requiring drug companies to carry out post-market safety studies, and prohibiting direct-to-consumer drug advertisements for the period after a new drug enters the market. Proposal implications and legislative efforts at drug safety reform will be discussed.

Session Objectives: Recognize the critical role of the FDA in assuring the safety of medications. Identify the limitations of the drug safety system in the U.S. and the key recommendations of the Institute of Mediicne to address these problems. Analyze the main arguments for and against implementation of recommended changes in the drug safety system.

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