Chapter

Regulation of Drugs and Health Care Products

Robert I. Field

in Health Care Regulation in America

Published in print October 2006 | ISBN: 9780195159684
Published online September 2009 | e-ISBN: 9780199864423 | DOI: http://dx.doi.org/10.1093/acprof:oso/9780195159684.003.0005
Regulation of Drugs and Health Care Products

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This chapter reviews the regulation of drugs and products for safety and efficacy. It begins with a history of drug regulation, covering public health crises that engendered major expansions in 1906, 1938, and 1962. It then explains the oversight process for drugs and devices administered by the Food and Drug Administration (FDA) from clinical trials through post-market safety monitoring. More recent regulatory programs address a host of other issues. Several relate to marketing concerns, such as generic drug availability, off-label promotion, direct-to-consumer advertising, and reimportation of drugs at lower prices. Others address such disparate concerns as pediatric testing, access to experimental medications, and the safety of herbal supplements. The chapter also considers issues in food safety oversight, regulation of controlled substances, and drug coverage under Medicare Part D. It concludes by reviewing the policy debate over whether FDA strikes the right balance between assuring safety and availability of new drugs.

Keywords: drugs; pharmaceuticals; prescriptions; medical devices; foods; generic drugs; patent; Food and Drug Administration

Chapter.  12279 words. 

Subjects: Public Health and Epidemiology

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