• The organizational culture of CDER and its determinants, and how organizational culture may affect the center’s performance in assessing and acting on the evolving understanding of risk and benefit over the drug lifecycle;

  • Key factors of regulatory science and processes (methods, data resources, expert advice, independence) necessary to enhance drug safety;

  • The regulatory authorities necessary to provide for drug safety;

  • The communication structure needed to support an effective drug safety system; and

  • The financial resources required to enable CDER to meet its responsibilities in supporting the FDA mission.

In its information gathering, the committee became aware of multiple proposals to strengthen the drug safety system that have been made in the past and have addressed many of the areas outlined. In its work, the committee has attempted to develop a coherent and integrative approach to transforming drug safety programs that encompasses the categories described above. The committee made several overarching findings. First, there is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry (Harris Interactive, 2005; Pricewaterhouse-Coopers’ Health Research Institute, 2005). Second, the committee learned that most stakeholders—the agency, the industry, consumer organizations, Congress, professional societies, health care entities—appear to agree on the need for certain improvements in the system. Third, the committee found that the drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement. Fourth, the committee found that FDA, contrary to its public health mission, and the pharmaceutical industry, contrary to its responsibility to the users of its products (and its shareholders), do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.

The committee’s vision of a transformed drug safety system has at its core a lifecycle approach to drug risk and benefit—not a new concept, but one that has been implemented, at best, in a limited and fragmented manner. For FDA, attention to risk and benefit over a drug’s lifecycle would require continuous availability of new data and ongoing, active reassessment of risk and benefit to drive regulatory action (responsive to the accumulating information about a given drug), and regulatory authority that is strong both before and after approval. For the industry, attention to risk and benefit over



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