tory jurisdiction and its enforcement powers. The statute empowers FDA to bring enforcement actions through administrative procedures (warning letters, adverse publicity, recalls, and withdrawals of product approvals) and judicial procedures (seizure, injunction, and prosecution) (Bass, 1997; Levine, 2002). FDA’s enforcement authority is derived by delegation from the secretary of the Department of Health and Human Services (DHHS) to the commissioner of food and drugs (Bass, 1997). Regulations contained in the Code of Federal Regulations empower FDA to enforce the FD&C Act and other statutes, as appropriate. FDA’s ability to regulate is also influenced by Congress and its “oversight jurisdiction” exercised by holding congressional hearings (Hutt, 1991). The judiciary branch also may influence FDA regulation, when FDA’s interpretations of the statute and its development of regulations are successfully challenged in court.


The statutory authority for drug regulation was constructed decades ago, and it remains largely unchanged. The existing regulatory framework is structured around the premarketing testing process; few tools are available for addressing postmarketing safety issues, short of the blunt instruments to respond to clear-cut adulteration and misbranding. As described in Chapter 1, the sciences of drug discovery and development, the practice of medicine and the extent of drug use, and the information environment in which health care providers practice and patients learn about drugs and interact with the health care delivery system have all changed. It is time to reassess and strengthen FDA’s postmarketing authorities and tools in view of these changes. The carefully controlled clinical trials currently conducted premarket under the existing statutory framework consists of study populations that are commonly different in composition and health status from populations that will use the marketed drug. Study populations are chosen for a legitimate reason: to make data from the trials clearer and thus to make safety and efficacy testing more efficient. After approval, drugs are used by larger and more heterogeneous populations, and by people who have comorbidities or are taking multiple prescription and over-the-counter drugs and dietary supplements. Furthermore, the promotion of drugs has moved beyond health care providers, and substantial industry investment goes into directly targeting consumers. It also has become more important to recognize that the assessment of a drug’s risk-benefit profile does not remain static after approval. Every effort must be made to monitor the performance of drugs on the market, to identify safety problems early, and to address them effectively. FDA’s ability to regulate drugs effectively in a rapidly changing context requires reconsideration of the laws and a clarification and strengthening of the agency’s regulatory authority.

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