Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals
- 9 April 2009
- journal article
- review article
- Published by Massachusetts Medical Society in The New England Journal of Medicine
- Vol. 360 (15), 1557-1566
- https://doi.org/10.1056/nejmhle0807695
Abstract
In January, the Food and Drug Administration (FDA) issued guidance permitting pharmaceutical and device manufacturers to distribute reprints of articles from medical journals that discuss the off-label use of products. The authors review the history of FDA regulation of off-label promotion and discuss the pertinent legal and policy issues.Keywords
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