Safeguarding Patient Welfare: Who's In Charge?
Authors: Jane E. Henney
Journal: Annals of Internal Medicine (2006)

Editorials15 August 2006Safeguarding Patient Welfare: Who's In Charge?Jane E. Henney, MDJane E. Henney, MDFrom University of Cincinnati, Cincinnati, OH 45267.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-145-4-200608150-00013 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Over the course of my career, I have been privileged to serve in a variety of roles, including that of oncologist, principal investigator, study manager, senior academic administrator, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), and as board member for 3 Fortune 500 and Global 500 companies (AstraZeneca PLC, 2001 to present; AmerisourceBergen Corporation, 2002 to present; and Cigna Corporation, 2004 to present). I have been regulated and a regulator, and I have led institutions striving to develop and advance new investigational therapies within a heavily regulated environment. This experience has afforded me a ...References1. Steinman MA, Bero LA, Chren M, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145:284-93. LinkGoogle Scholar2. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021-6. [PMID: 16682577] CrossrefMedlineGoogle Scholar3. United States ex rel. David Franklin v. Parke-Davis, 147 F. Supp. 2d 39 (D. Mass. 2001). Google Scholar4. U.S. Food and Drug Administration. Final guidance on industry-supported scientific and educational activities. Fed Reg. 1997;62:64074-92. Google Scholar5. U.S. Food and Drug Administration. Advertising and promotion; guidances. Fed Reg. 1996;61:52800-1. Google Scholar6. Requirements for dissemination of treatment information on drugs or devices. 21 USC § 360(aaa); 1998. Google Scholar7. Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D. DC 1998). Google Scholar8. Washington Legal Foundation v. Friedman, 36 F. Supp. 2d 16 (D. DC 1999). Google Scholar9. Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D. DC 1999). Google Scholar10. Washington Legal Foundation v. Henney, 202 F.3d 331, 335 (DC Cir. 2000). Google Scholar11. Thompson v. Western States Medical Center, 535 US 357 (2002). Google Scholar12. Pearson v. Shalala, 130 F.Supp. 2d 105 (D. DC 2001). Google Scholar13. U.S. Food and Drug Administration. Request for comment on First Amendment issues. Fed Reg. 2002;67:34942. Google Scholar14. Pharmaceutical Research and Manufacturers of America. PhRMA Code on Interactions with Healthcare Professionals. Washington, DC: Pharmaceutical Research and Manufacturers of America; 2004. Google Scholar15. Office of the Inspector General. OIG compliance program guidance for pharmaceutical manufacturers. 68 Fed Reg. 2003;68:23731-43. Google Scholar16. Chimonas S, Rothman DJ. New federal guidelines for physician-pharmaceutical industry relations: the politics of policy formation. Health Aff (Millwood). 2005;24:949-60. [PMID: 16136634] CrossrefMedlineGoogle Scholar17. Coleman DL, Kazdin AE, Miller LA, Morrow JS, Udelsman R. Guidelines for interactions between clinical faculty and the pharmaceutical industry: one medical school's approach. Acad Med. 2006;81:154-60. [PMID: 16436576] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Jane E. Henney, MDAffiliations: From University of Cincinnati, Cincinnati, OH 45267.Disclosures:Employment: University of Cincinnati; Consultancies: AstraZeneca, Cigna Corporation, MPM BioVentures, AmerisourceBergen Corporation; Honoraria: Deutsche Bank, CIBC World Markets, Northwestern University, American Council on Consumer Interests; Stock ownership or options (other than mutual funds): AstraZeneca, Cigna Corporation, AmerisourceBergen Corporation.Acknowledgment: The author thanks Robin Dreisigacker, JD, for her assistance with the background research for this editorial.Corresponding Author: Jane E. Henney, MD, Office of the Senior Vice President and Provost for Health Affairs, University of Cincinnati Academic Health Center, PO Box 670663, Cincinnati, OH 45267-0663; e-mail, [email protected]UC.EDU. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoNarrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents Michael A. Steinman , Lisa A. Bero , Mary-Margaret Chren , and C. Seth Landefeld Metrics Cited bySorrell v. IMS Health: issues and opportunities for informaticiansStrategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower ComplaintsEvaluating Off-Label Uses of Anticancer Drugs: Time for a ChangeHarold C. Sox, MD, EditorPharmacotherapy of Schizophrenic Patients: Preponderance of Off-Label Drug UsePharmaceutical Promotion to Physicians and First Amendment Rights 15 August 2006Volume 145, Issue 4Page: 305-307KeywordsConflicts of interestDrug marketingDrug research and developmentDrugsFoodFood and Drug AdministrationHealth careHealth promotionMedical educationSafety studies ePublished: 15 August 2006 Issue Published: 15 August 2006 Copyright & PermissionsCopyright © 2006 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...