FDA unveils drug safety plan

The FDA has issued a report detailing the steps the agency intends to take to improve its oversight of drug safety. The plan is centered on three main goals: strengthening the science behind the safety system, improving communication among all stakeholders, and improving operations and management.

The report was drafted in part to respond to a set of recommendations made last year by the National Academy of Sciences' Institute of Medicine, an independent non-profit group, at the request of the FDA.

To improve communication and information flow among stakeholders, the FDA plans to form a new advisory committee that will provide input on the agency's risk-communication policies. The committee will be made up of patients, consumers, experts in risk communication and crisis communication, and thought leaders from the fields of social science and cognitive science.

In addition, in early 2007, the agency will issue a final guidance on communicating drug safety information, including emerging drug safety information, to the public.

The FDA will begin regular publication in 2007 of a web-based newsletter containing summaries of the results of its postmarketing drug reviews. The newsletter will also feature information on emerging safety issues and on recently approved products ìboth to inform providers and to encourage reporting to the agency,î the report states. The FDA stressed, however, that the summaries in the newsletter ìwill not include confidential commercial or predecisional information.î

To strengthen the science that supports its medical product safety system, the FDA intends to undertake initiatives including ìdeveloping new scientific approaches to detecting, understanding, predicting, and preventing adverse events, developing and incorporating new quantitative tools in the assessment of benefit and risk, and conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis.î

In the areas of operations and management, the FDA aims to make improvements ìto ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the US drug safety system.î These steps will include hiring external consultants to help the Center for Drug Evaluation and Research (CDER) improve its organizational culture.

The agency's report, entitled ìThe Future of Drug Safety,î also highlights a new information-sharing agreement between the FDA and the Veterans Health Administration aimed at improving postmarket medical product safety data collection and risk communication, as well as the implementation of an electronic safety tracking system across CDER.

The FDA has come under fire for its approval of drugs such as Merck's Vioxx (rofecoxib), which had to be recalled due to safety concerns, and has vowed to improve its oversight of drug safety. In 2005, the agency created the Drug Safety Oversight Board to provide oversight and advice to CDER's director.