Contradictory actions on off-label use of prescription drugs? The FDA and CMS versus the U.S. Justice Department

Journal of Managed Care Pharmacy

Volumn 15, Issue 2, 2009, Pages 161-165

  Curtiss, Frederic R ^a   Fairman, Kathleen A ^b  

^a Academy of Managed Care Pharmacy   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTICONVULSIVE AGENT; ANTINEOPLASTIC AGENT; ATYPICAL ANTIPSYCHOTIC AGENT; BEVACIZUMAB; CAPECITABINE; CETUXIMAB; DULOXETINE; GABAPENTIN; GEMCITABINE; OLANZAPINE; OXALIPLATIN; PREGABALIN; QUETIAPINE; RISPERIDONE; TRICYCLIC ANTIDEPRESSANT AGENT; VALDECOXIB; VENLAFAXINE; ZIPRASIDONE;

AUTISM; BIPOLAR DISORDER; CLINICAL PRACTICE; CLINICAL TRIAL; COLORECTAL CANCER; DEMENTIA; DEPRESSION; DIABETES MELLITUS; DIABETIC NEUROPATHY; DIGESTIVE SYSTEM PERFORATION; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG INFORMATION; DRUG MARKETING; DRUG SAFETY; EDITORIAL; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GILLES DE LA TOURETTE SYNDROME; GOVERNMENT; HEALTH PROMOTION; HUMAN; LAW SUIT; MEDICARE; NEUROPATHIC PAIN; OBSESSIVE COMPULSIVE DISORDER; OFF LABEL DRUG USE; OVARY CANCER; OVERALL SURVIVAL; PEER REVIEW; PERSONALITY DISORDER; PHYSICIAN ATTITUDE; POSTTRAUMATIC STRESS DISORDER; PRESCRIPTION; QUALITY OF LIFE; RISK BENEFIT ANALYSIS; SCHIZOPHRENIA; UNITED STATES; UNSPECIFIED SIDE EFFECT; UTERINE CERVIX CANCER;

EID: 63349097242     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2009.15.2.161     Document Type: Editorial

References (41)

1. U.S. Department of Justice. Eli Lilly and Company agrees to pay $1.415 billion to resolve allegations of off-label promotion of Zyprexa. No. 09-038. January 15, 2009. Available at: http://www.usdoj.gov/opa/pr/2009/January/09-civ-038.html. Accessed February 3, 2009.
2. U.S. Food and Drug Administration. Zyprexa product label and approval history. Available at: http://www.accessdata.fda.gov/scripts/cder/ drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=ZYPREXA. (Search on "Zyprexa"). Accessed February 3, 2009.
3. Edwards J. How Pfizer hid a $2.3 bill. Bextra settlement in plain sight. BNet. January 26, 2009. Available at: http://industry.bnet.com/ pharma/1000656/how-pfizer-hid-a-23-bill-bextra-settlement-in-plain- sight/. Accessed February 7, 2009.
4. Winslow R. Pfizer sets $2.3 billion settlement - agreement with U.S. tied to alleged off-label marketing of painkiller Bextra. Wall Street J. January 27, 2009. Available at: http://online.wsj.com/ article/SB123301757444517869.html?mod=rss_Health. Accessed February 9, 2009.
5. U.S. Department of Justice. Warner-Lambert to pay $430 million to resolve criminal & civil health care liability relating to off-label promotion. No. 04-322. May 13, 2004. Available at: http://www.usdoj.gov/ opa/pr/2004/May/04_civ_322.htm. Accessed February 7, 2009.
6. Whalen J. Glaxo warns of charge, hints at pact. Wall Street J. January 30, 2009:B3. Available at: http://online.wsj.com/article/ SB123327051846730799.html?mod=todays_us_marketplace. Accessed February 9, 2009.
7. U.S. Food and Drug Administration. Guidance for industry - good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices U.S. January 2009. Available at: http://www.fda.gov/oc/op/goodreprint.html. Accessed February 7, 2009.
8. U.S. Food and Drug Administration. FDA proposes guidance for dissemination of information on unapproved uses of medical products - agency accepting public comments for 60 days. February 15, 2008. Available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html. Accessed February 7, 2009.
9. DeAngelis CD, Fontanarosa PB, Impugning the integrity of medical science - the adverse effects of industry influence. JAMA. 2008;299(15):1833-35.
10. Ross JS, Hill KP, Egilman DS, Krumhoz HM. Guest authorship and ghostwriting in publications related to rofecoxib. A case study of industry documents from rofecoxib litigation. JAMA. 2008;2999(15):1800-12.
11. Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med. 2007;4(9):1429-33. Available at: http://medicine.plosjournals.org/ archive/1549-1676/4/9/pdf/10.1371_journal.pmed.0040286-L.pdf. Accessed February 7, 2009.
12. Steinman MA, Bero L, Chren M, Landefeld C. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145(4):284-93. Available at: http://www.annals.org/cgi/reprint/145/4/284.pdf. Accessed February 7, 2009.
13. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Intern Med. 2008;149:251-58.
14. Psaty BM, Ray W. FDA guidance on off-label promotion and the state of the literature from sponsors. JAMA. 2008;299(16):1949-51.
15. Turner EH, Matthews A, Linardatos E, Tell R, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-60. Available at: http://content.nejm.org/cgi/reprint/358/3/252.pdf. Accessed February 7, 2009.
16. Gøtzsche PC, Hrobjartsson A, Johansen H, Haahr M, Altman D, Chan A. Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007;4(1):e19. Available at: http://www.pubmedcentral.nih.gov/ picrender.fcgi?artid=1769411&blobtype=pdf. Accessed February 7, 2009.
17. CMS Medicare Learning Network. Compendia as authoritative sources for use in the determination of a "medically accepted indication" of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen. MM 6191, CR6191. October 24, 2008. Available at: http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6191.pdf. Accessed February 10, 2009.
18. Agency for Healthcare Research and Quality. Technology assessment. Compendia for coverage of off-label uses of drugs and biologies in an anticancer chemotherapeutic regimen. Final report. May 2, 2007. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/ id46TA.pdf. Accessed February 7, 2009.
19. Abelson R, Pollack A. Medicare widens drugs it accepts for cancer. NY Times. January 26, 2009. Available at: http://www.nytimes.com/2009/ 01/27/health/27cancer.html?_r=2&ref=health. Accessed February 3, 2009.
20. Nimeiri HS, Oza AM, Morgan RJ, et al. Efficacy and safety of bevacizumab plus erlotinib for patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer: a trial of the Chicago, PMH, and California Phase II Consortia. Gynecol Oncol. 2008;119(1):49-55.
21. Cannistra SA, Matulonis UA, Penson RT, et al. Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. J Clin Oncol. 2007;25(33):5180-86.
22. Mayer MJ. Targeted therapy for advanced colorectal cancer - more is not always better. N Engl J. Med. 2009;360(6):623-25.
23. Tol J, Koopman M, Cats A, et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med. 2009;360:563-72.
24. Bach PB. Limits on Medicare's ability to control rising spending on cancer drugs. N Engl J Med. 2009;360(6):626-33.
25. Phurrough S, Jacques L, Ciccanti M, Turner T, Roller E, Feinglass S. Proposed coverage decision memorandum for the use of erythropoiesis stimulating agents in cancer and related neoplastic conditions. May 14, 2007. Available at: http://www.cms.hhs.gov/determinationprocess/ downloads/id203d.pdf. Accessed February 9, 2009.
26. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Historical information on erythropoiesis stimulating agents (ESA). Available at: http://www.fda.gov/cder/drug/infopage/RHE/ historical.htm. Accessed February 9, 2009.
27. U.S. Food and Drug Administration. MedWatch. 2008 safety alerts for human medical products. Erythropoiesis stimulating agents (ESAs) - epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp), Update December 2, 2008. Available at: http://www.fda.gov/ medwAtch/safety/2008/safety08.htm#ESA2. Accessed February 10, 2009.
28. Stafford RS. Regulating off-label drug use - rethinking the role of the FDA. N Engl J Med. 2008;358(14):1427-29 Available at: http://content.nejm.org/cgi/reprint/358/14/1427.pdf. Accessed February 3, 2009.
29. St. Onge EL, Miller SA. Pain associated with diabetic peripheral neuropathy - a review of available treatments. P&T. 2008;33(3):166-75.
30. Agency for Healthcare Research and Quality. National Guideline Clearinghouse. Assessment and management of chronic pain. Update July 2008. Available at: http://www.guideline.gov/summary/ summary.aspx?ss=14&doc_id=12998&string=Painful+AND+diabetic+AND+ neuropathy. Accessed February 10, 2008.
31. Backonja M, Beydoun A, Edwards KR, et al. Gapbapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus - a randomized controlled trial. JAMA. 1998;280(21):1831-36. Available at: http://jama.ama-assn.org/cgi/reprint/ 280/21/1831. Accessed February 10, 2009.
32. Canadian Agency for Drugs and Technologies in Health. Technology Overview, HTA Issue 49. January 2009. Available at: http://cadth.ca/ media/pdf/O0458_Management_of_Neuropathic_Pain_to_e.pdf. Accessed February 13, 2009.
33. Agency for Healthcare Research and Quality. Effective Health Care. Efficacy and comparative effectiveness of off-label use of atypical antipsyphotics. No. 6. January 2007. Available at: http://effectivehealthcare.ahrq.gov/repFiles/ Atypical_Executive_Summary.pdf. Accessed February 7, 2009.
34. Hall RF, Sobotka ES. Inconsistent government policies: why FDA off-label regulation cannot survive First Amendment review under Greater New Orleans. Food Drug Law J. 2007;61:1-48.
35. Kesselheim AS, Avorn J. Pharmaceutical promotion to physicians and first amendment rights. N Engl J Med. 2008;358(16):1727-32.
36. Steinman MA, Harper GM, Chren M, Landefeld CS, Bero LA. Characteristics and impact of drug detailing for gabapentin. PLoS Med. 2007;4(4):e134. Available at: http://medicine.plosjournals.org/archive/ 1549-1676/4/4/pdf/10.1371_journal.pmed.0040134-S.pdf. Accessed February 7, 2009.
37. Zimmerman R. A unit of Pfizer is target of lawsuit over its marketing. Wall Street J. March 15, 2002:B3.
38. Petersen M. Court papers suggest scale of drug's use. NY Times. May 30, 2003.
39. Armstrong, D. Maker of epilepsy drug used misleading data, plaintiff says. Wall Street J. May 30, 2003:B4.
40. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021-26. Available at: http://archinte.ama-assn.Org/cgi/reprint/166/9/1021. Accessed February 17, 2009.
41. Kmietowicz Z., Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine. BMJ. 2009;338:b217; online first January 23, 2009.