FDA Responds to IOM Recommendations
Last week, the FDA responded to the Institute of Medicine's 2006 report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public." In the FDA's press release, the FDA noted plans to increase drug safety by taking actions in support of the following (as taken directly from the press release):
- Strengthening the science that supports the FDA's medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management;
- FDA initiatives include developing 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.
- Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products; and
- FDA initiatives include the establishment of an advisory committee to provide input to improve the agency's risk communication policies and practices, conducting a comprehensive review of current public communication tools and developing a comprehensive risk communication strategic plan.
- Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.
- FDA initiatives include engaging external management consultants to help the Center for Drug Evaluation and Research (CDER) develop a comprehensive strategy for improving CDER's organizational culture, and making specific organizational and management changes to increase communications among review and safety staff.
