title: Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
abstract: Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA 98195, USA. deyo@u.washington.edu
authors.forename: Richard A
authors.initials: RA
authors.lastname: Deyo
mesh_terms: D016265:Conflict of Interest; D003253:Consultants; D003659:Decision Making, Organizational; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000941:ethics*