title: The FDA's regulation of health economic information.
abstract: Section 114 of the Food and Drug Administration Modernization Act of 1997 was intended to increase the flow of health economic information from pharmaceutical manufacturers to managed care decisionmakers. But the legislation raises a host of complex questions and has provoked diverse opinions from inside and outside the pharmaceutical industry. Moreover, the Food and Drug Administration (FDA) has yet to issue interpretative guidance on the subject. The challenge in implementing Section 114 lies in developing a policy that improves health economic information exchange while protecting consumers from misleading claims and preserving incentives for manufacturers to conduct rigorous studies.
authors.affiliation: Department of Health Policy and Management, Harvard School of Public Health, USA.
authors.forename: P J
authors.initials: PJ
authors.lastname: Neumann
authors.forename: K
authors.initials: K
authors.lastname: Claxton
authors.forename: M C
authors.initials: MC
authors.lastname: Weinstein
mesh_terms: D004345:Drug Industry / Q000191:economics*; D004346:Drug Information Services / Q000331:legislation & jurisprudence*; D017850:Economics, Pharmaceutical / Q000706:statistics & numerical data*; D019317:Evidence-Based Medicine; D006291:Health Policy / Q000331:legislation & jurisprudence; D006801:Humans; D008329:Managed Care Programs / Q000191:economics*; D009042:Motivation; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D012106:Research / Q000458:organization & administration; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*