in five major areas: organizational culture and leadership, science, regulatory authority, communication, and the funding without which improvements in these areas would not be possible. No one in FDA, industry, or academic research enterprise would disagree with the importance of implementing a lifecycle approach to the assessment of drug risks and benefits. Nevertheless, a great deal of separation persists between premarket and postmarket activities and functions. The separation, both structural and cultural, is reinforced by user-fee funding that is predominantly devoted to premarket activities and funding from appropriations that has not kept up with need in vital areas of the agency’s work, by regulatory authority that is stronger and clearer preapproval, and by data requirements that are more structured and intensive for approval than for the postmarketing period (see Chapter 3) (DHEW Review Panel on New Drug Regulation, 1977; FDA, 2005b).

The year 2006 is a good time for thoughtful attention to transforming the drug safety system to address existing areas of vulnerability, and to prepare for the challenges and opportunities of the future. In this year of FDA’s centennial,1 public attention to drug safety matters has reached a high point, negotiations in advance of the September 2007 sunset of PDUFA have begun, Medicare Part D has enrolled tens of millions of senior citizens in a system that is expected to yield a wealth of population data about experience with drugs, new research promises further progress against illness (including more targeted therapies), and congressional interest in drug safety is intense. Those are but some of the factors that make this a moment of opportunity to renew and transform CDER, to enable it to function more effectively and to position itself for a far more complex future.

Changes in the Broad Context of Drug Regulation

Prescription drug development, regulation, and use have changed greatly since the 1962 drug amendments and continue to evolve. The scientific and demographic changes of the future will present challenges and opportunities for drug development and regulation. The promise of personalized medicine shimmers on the horizon, but considerable work remains to identify candidate measures, validate them, and show that their use in a clinical setting improves health outcomes, reduces costs, or both. The population of the United States is aging and requires more therapeutics for prevention and treatment for the chronic diseases associated with older people. Increasing ethnic and cultural diversity will require better under-

1

The year 2006 is technically the centennial of the 1906 Pure Food and Drug Act, but the FDA asserts that “the modern era of the FDA dates to 1906 with the passage of the Federal Food and Drugs Act” (CDER, 1998).



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