postmarket study commitments) and that both government and industry, in collaboration with others, bear the responsibility for funding other clinical trials or observational studies performed for broader public health objectives rather than specific regulatory purposes. Industry also has a social responsibility to make sure that its products are safe and effective, so it should contribute to these trials of public health importance. The secretary of DHHS should provide funding for the administrative management of the partnership, but funds for the research will need to come from a variety of sources. CDER will need support from the FDA commissioner and from the secretary of DHHS to use the information from the studies for the best regulatory policy-making. The committee understands that priority-setting and collaboration will not be easy, but they are necessary for advances in drug safety.

Risk Minimization Action Plans

As described above, some drug safety problems are suspected, some are unknown and unsuspected, and others are known at the time of approval. Risk management is an iterative process that encompasses the assessment of risks and benefits, the minimization of risks, and the maximization of benefits. The committee views with concern the CDER statement that the “cornerstone” of risk management encompasses “efforts to make FDA-approved professional labeling clearer, more concise, and better focused on information of clinical relevance” (FDA, 2005b). There is widespread acknowledgment that product labeling has not been a very effective means of communication to prescribers about risk management.

PDUFA III required FDA to issue guidances to industry on risk management. The preceding sections of this chapter describe tools to assess and clarify drug risks and benefits. Risk minimization is the effort to minimize risks already identified. Risk minimization action plans (RiskMAPs) constitute a relatively new approach to minimizing known risks of a drug beyond the standard industry responsibilities related to routine risks, such as labeling and reporting of AEs. According to the guidance entitled “Guidance for Industry, Development and Use of Risk Minimization Action Plans,” “RiskMAP means a strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits. A RiskMAP targets one or more safety-related health outcomes or goals and uses one or more tools to achieve those goals” (FDA, 2005b). The guidance describes the following possible RiskMAP tools:

  • Targeted education and outreach to communicate risks and appropriate safety behaviors to healthcare practitioners or patients.



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