Risk Management Report Issued

As once of her first initiatives after being sworn in as FDA Commissioner, Dr. Jane Henney established a Task Force to look into public concerns about the risk management system, and to comprehensively evaluate the current system for managing the risks of FDA-approved products. The 164-page report of the Task Force, along with a separate Executive Summary, are available on the FDA homepage on the Internet at http://www.fda.gov/oc/tfrm/riskmanagement.pdf. Part 1 of the report provides a general discussion of the risks involved in medical product use and an overview of the risk management system and FDA's role in that system. Parts 2 and 3 discuss the Agency's premarketing and postmarketing risk assessment activities. Part 4 takes a broad look at the overall risk management system and makes recommendations for creating a new systems model.

The key recommendation of the Task Force is that FDA convene a meeting, or series of meetings, with stakeholders (e.g., healthcare practitioners, healthcare provider organizations, patients, the public and industry) to discuss the current system for managing risks and consult about various options identified in the report. In summary, these options, described in more detail in the report, might include:

• Examine and evaluate mechanisms designed to address the inherent limits of premarketing development (e.g., wider use of large, community based simple trials, restricting exposure during the early postmarketing period).
• Design and implement additional mechanisms to obtain postmarketing information (e.g., sentinel sites, prospective product use registries, enhanced links to external databases).
• Enhance Agency epidemiological and methodological research activities.
• Enhance the Agency's role and responsibilities in risk communication
• Increase the number of postmarketing risk interventions for products with special risks, such as restricting distribution of products or requiring mandatory educational programs for healthcare professionals and patients.
• Seek legislative changes for other types of risk intervention, such as suspension authority for drugs.

(Hypertext created by tg 1999-JUL-09)