Off-label prescribing is a fundamental fact of life of healthcare systems, but the promotion of off-label uses by drug sponsors is a fundamental sin. Regulators, legislators and drug makers are wrestling to find the right balance.
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References
Silverman, E. Amgen and Enbrel marketing: crossing another line? Pharmalot (February 6, 2008) http://www.pharmalot.com/2008/02/amgen-enbrel-marketing-crossing-another-line/
Radley, D.C. et al. Arch. Intern. Med. 166, 1021–1026 (2006).
Casali, P.G. Ann. Oncol. 18, 1923–1925 (2007).
BBC News. Tighter drug trial laws promised, March 6, 2008.
Conroy, S., Newman, C. & Gudka, S. Ann. Oncol. 14, 42–47 (2003).
Boos, J. Ann. Oncol. 14, 1–5 (2003).
Goldstein, J. The FDA contradicts Genentech on eye drug. The Wall Street Journal Health Blog (June 17, 2008) http://blogs.wsj.com/health/2008/06/17/fda-contradicts-genentech-on-eye-drug/
Avorn, J. & Soumerai, S.B. N. Engl. J. Med. 308, 1457–1463 (1983).
Avorn, J. et al. N. Engl. J. Med. 327, 168–173 (1992).
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Ratner, M., Gura, T. Off-label or off-limits?. Nat Biotechnol 26, 867–875 (2008). https://doi.org/10.1038/nbt0808-867
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DOI: https://doi.org/10.1038/nbt0808-867
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