New federal guidelines for physician-pharmaceutical industry relations: The politics of policy formation

Health Affairs

Volumn 24, Issue 4, 2005, Pages 949-960

  Chimonas, Susan ^a   Rothman, David J ^a  

^a College of Physicians and Surgeons ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; ECONOMICS; EDUCATION; FINANCIAL MANAGEMENT; FORGERY; GIFT GIVING; GOVERNMENT; GOVERNMENT REGULATION; HEALTH CARE AND PUBLIC HEALTH; HEALTH CARE POLICY; HEALTH INSURANCE; LEGAL APPROACH; LEGAL ASPECT; MANAGEMENT; MEDICAL SOCIETY; PHYSICIAN; POLITICS; PRACTICE GUIDELINE; PUBLIC RELATIONS; REVIEW; STANDARD; UNITED STATES;

HEALTH CARE AND PUBLIC HEALTH; LEGAL APPROACH;

DRUG INDUSTRY; FRAUD; GIFT GIVING; GOVERNMENT REGULATION; GUIDELINES; HEALTH POLICY; INSURANCE, PHARMACEUTICAL SERVICES; INTERINSTITUTIONAL RELATIONS; PHYSICIANS; POLICY MAKING; POLITICS; RESEARCH SUPPORT; SOCIETIES, MEDICAL; TRAINING SUPPORT; UNITED STATES; UNITED STATES GOVERNMENT AGENCIES;

EID: 23044437123     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.24.4.949     Document Type: Review

References (48)

1. Pharmaceutical Research and Manufacturers of America, PhRMA Code on Interactions with Healthcare Professionals, 1 July 2002, www.phrma.org/ publications/policy/2004-01-19.391.pdf (16 March 2005);
2. and American Medical Association, "Ethical Guidelines for Gifts to Physicians from Industry," June 1998, www.ama-assn.org/ama/pub/category/ 4001.html (16 March 2005).
3. U.S. Department of Health and Human Services, Office of Inspector General, "Compliance Program Guidance for Pharmaceutical Manufacturers," Federal Register 68, no. 86 (2003): 23731-23743.
4. OIG, State Strategies to Contain Medicaid Drug Costs, October 2003, www.oig.hhs.gov/oei/reports/oei-05-02-00680.pdf (16 March 2005).
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16. Loucks, "Department of Justice Investigations."
17. Loucks, "Department of Justice Investigations." Ibid.
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20. To obtain information about these meetings, we filed a second FOIA request. This brought us materials of little use: a brief meeting agenda, letters from die American Association of Health Plans and the Pharmaceutical Care Management Association reiterating their initial comments on the draft, and the Academy of Managed Care Pharmacies' published guidelines for drug formularies.
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23. and OIG, "Solicitation of New Safe Harbors and Special Fraud Alerts," Federal Register 66, no. 24 (2001): 65460-65461.
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26. OIG, "Compliance Program Guidance."
27. AMA's comments on the draft.
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29. OIG, "Draft OIG Compliance Program Guidance."
30. PhRMA's comments on the draft, submitted by Sidley Austin Brown and Wood LLP, obtained via FOIA.
31. Comments from nineteen pharmaceutical companies on the draft, submitted by Arnold and Porter and PriceWaterhouseCoopers LLP, obtained via FOIA.
32. OIG, "Compliance Program Guidance."
33. Comments from an anonymous pharmaceutical manufacturer, submitted by Kleinfeld Kaplan and Becker LLP, obtained via FOIA.
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37. and D. Katz, A.L. Caplan, and J.F. Merz, "All Gifts Large and Small: Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving," American Journal of Bioethics 3, no. 3 (2003): 39-46.
38. G. Harris, "Drug Makers Are Still Giving Gifts to Doctors, F.D.A. Officials Tell Senators," New York Times, 4 March 2004.
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40. A. Robeznieks, "OIG Issues Guidance on Drugmaker Gifts," AMNews, 19 May 2003, www.ama-assn.org/amednews/2003/05/19/prsa0519.htm (28 April 2005).
41. Associated Press, "In Selling to Doctors, Drug Companies Replace Entertainment with Education," Hannibal (MO) Courier-Post, 4 October 2002, www.hannibal.net/stories/100402/new_1004020045.shtml (28 April 2005).
42. T. Hosansky, "OIG Pharma Guidance: The Impact on CME," 19 June 2003, meetingsnet.com/ar/meetings_oig_pharma_guidance/index.htm (24 May 2005).
43. Pharma Congress Spring 2003, "HHS OIG Compliance Program Guidance for the Pharmaceutical Industry: Key Insights from Regulators and Compliance Experts" (Washington, D.C., 8-9 June 2003).
44. Office of the Attorney General, State of Vermont, "Vermont Attorney General Sorrell Charges Drug Companies with Antitrust Violations," Press Release, 12 August 2004, www.atg.state.vt.us/display.php?pubsec=4&curdoc=742 (16 March 2005).
45. California Senate Bill 1765, Chapter 927, September 2004, www.venable.com/docs/publication/1204.pdf (16 March 2005).
46. Nutter McClennen and Fish LLP, "New California Law Requires Comprehensive Compliance Programs for Pharmaceutical and Medical Device Companies," Client Advisory, nutter.com/news/images/CADrugLaw.pdf (8 April 2005).
47. Arnold and Porter LLP, "New California Law on Gifts to Health Care Providers: Interpretation Challenges and Liability Risks," Client Advisory, November 2004, www.arnoldporter.com/pubs/files/Advisory- CA_Laws_GiftstoHCProviders.pdf (16 March 2005).
48. P. Hooper, "State Law Issues" (Presentation at the Fifth Annual Pharmaceutical Regulatory and Compliance Congress, Washington, D.C., 14-17 November 2004).