Advertisement

Medical Affairs and Professional Services

  • Ronald P. Evens

Novel drug, device, and biologic pharmaceutical products are being developed across a host of human diseases to extend current medical treatment and improve patient care. The pipeline of drug development requires years of tireless scientific effort, health care provider relationships and support, patient dedication, public awareness, and business acumen to move a molecular entity from initial discovery, through the layers of clinical trials, and if successful, through negotiated regulatory approval by the U.S. Food and Drug Administration (FDA).

Keywords

Continue Medical Education United States Pharmacopeia Safe Harbor Adverse Drug Experience Patient Package Insert 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Health Care Industry Market Update. Available at http://www.cms. gov/reports/hcimu/hcimu_01102003.pdf.
  2. 2.
    Lamberti MJ (editor). An industry in evolution, 4th ed. Thomson CenterWatch, Boston, MA, 2003.Google Scholar
  3. 3.
    CenterWatch. 2002 in review: An industry in the balance. CenterWatch 2003;10(1):1–10.Google Scholar
  4. 4.
    Drug Topics Redbook 2005, 109th ed. Medical Economics Company, 2004.Google Scholar
  5. 5.
    Magazzini L, Pammolli F, Riccaboni M. Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure. Eur J Health Econ 2004 Jun;5(2):175–82.PubMedGoogle Scholar
  6. 6.
    Suh DC, Manning WG Jr, Schondelmeyer S, Hadsall RS. Effect of multiple-source entry on price competition after patent expiration in the pharmaceutical industry. Health Serv Res 2000 Jun;35(2):529–47.Google Scholar
  7. 7.
    Kirking DM, Ascione FJ, Gaither CA, et al. Economics and structure of the generic pharmaceutical industry. J Am Pharm Assoc (Wash) (United States), Jul-Aug 2001;41(4):578–84.Google Scholar
  8. 8.
    U.S. FDA. Current Good Manufacturing Practice for Active Pharmaceutical Ingredients: Guidance for Industry–Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients. Washington, DC: U.S. Food and Drug Administration, 1998.Google Scholar
  9. 9.
    Bender A, Shannon N. The firewall mandate. Pharmaceutical Executive 2003 (October supplement):20–26.Google Scholar
  10. 10.
    PhRMA Report, Prescription Medicines 24 Years ago and Today: Changing Trends, Enduring Needs, 2003.Google Scholar
  11. 11.
    Peddicord TE, Baker M, Oki J, Mouser JF, Hooks MA, Korth-Bradley JA. Casting call from industry: Reel in and retain appropriate information, release the rest. Pharmacotherapy 2002; 22(7):934–8.CrossRefPubMedGoogle Scholar
  12. 12.
    FDA Modernization Act of 1997 (FDAMA), November 21, 1997. Available at http://www.fda.gov/oc/fdama/default.htm.
  13. 13.
    Health Insurance Portability and Accountability Act of 1996 (HIPPA). Code of Federal Regulations 45.164.502(b) and 164.514(d). Public Law 104–191.Google Scholar
  14. 14.
    Department of Health and Human Services. Standards for Privacy of Individually Identifiable Health Information. Billing Code 4150–04M. Federal Register, Dec 28, 2000;82461–829 (45?CFR Parts 160–164).Google Scholar
  15. 15.
    Shannon ME, Malecha SE, Cha AJ, Moody ML. Evaluation and critical appraisal of a random sample of drug information practice in United States academic and industry medical information centers. Drug Info J 2000;34(4):1133–8.Google Scholar
  16. 16.
    Doyle RI, Song KH, Baker RP. An industry-wide evaluation of drug information services. Drug Info J 2000;34(4):1139–48.Google Scholar
  17. 17.
    Gundaker LF. Developing an automated telephone triage system for a new product launch. Drug Info J 2000;34(4):1035–39.Google Scholar
  18. 18.
    Code of Federal Regulations 21.202.1(I) (2). Drugs. Prescription drug advertising.Google Scholar
  19. 19.
    Food, Drug & Cosmetic Act Section 201 (m) Drugs. Labeling.Google Scholar
  20. 20.
    Basara LR, Juergens JP. Patient package insert readability and design. Am Pharm 1994 Aug;NS34(8):48–53.Google Scholar
  21. 21.
    Williams-Deane M, Potter LS. Current oral contraceptive use instructions: an analysis of patent package inserts. Fam Plann Perspect 1992 May-Jun;24(3):111–5.CrossRefPubMedGoogle Scholar
  22. 22.
    Rowe HM. Patient package inserts: the proper prescription? Food Drug Law J 1995;50(1):95–124.PubMedGoogle Scholar
  23. 23.
    Code of Federal Regulations 21.310.501. Patient Package Insert, Oral Contraceptives.Google Scholar
  24. 24.
    Code of Federal Regulations 21.310.515. Patient Package Insert, Estrogens.Google Scholar
  25. 25.
    Code of Federal Regulations 21.310.516. Patient Package Insert. Progestational products.Google Scholar
  26. 26.
    Frequently asked questions about CDER. Available at http://www.fda.gov/cder/about/faq/default.htm7.
  27. 27.
    Code of Federal Regulations 21.99. Dissemination of Information on Unapproved / New Uses for marketed drugs, biologics and devices.Google Scholar
  28. 28.
    Wolgemuth RL. Realizing the promise of the US Food and Drug Administration Modernization Act. Clin Ther 1998;20(Suppl C): C26–31.CrossRefGoogle Scholar
  29. 29.
    Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003;19:149–54. Available at: http://www.gpp-guidelines.org/.Google Scholar
  30. 30.
    Pilnick A, Dingwall R, Starkey K. Disease management: definitions, difficulties and future directions. Bull World Health Organ 2001;79(8):755–63.PubMedGoogle Scholar
  31. 31.
    Ara S. A literature review of cardiovascular disease management programs in managed care populations. J Manag Care Pharm 2004 Jul-Aug;10(4):326–44.PubMedGoogle Scholar
  32. 32.
    Pelletier KR. A review and analysis of the clinical- and cost-effectiveness studies of comprehensive health promotion and disease management programs at the worksite: 1998–2000 update. Am J Health Promot 2001 Nov-Dec;16(2):107–16.CrossRefPubMedGoogle Scholar
  33. 33.
    Posey LM. Pfizer cuts disease management deal with Florida Medicaid but nurses may provide services. Pharmacy Today 2001;7(8):1–7.Google Scholar
  34. 34.
    Wall Street Journal, July 9, 2001. Pfizer makes a deal with Florida Medicaid.Google Scholar
  35. 35.
    Duke KS, Raube K, Lipton HL. Patient-assistance programs: Assessment of and use by safety-net clinics. Am J Health-Syst Pharm 2005;62(7):726–31.PubMedGoogle Scholar
  36. 36.
    Kennedy DL, Uhl K, Kweder SL. Pregnancy exposure registries. Drug Saf 2004;27(4):215–28.CrossRefPubMedGoogle Scholar
  37. 37.
    Gare BA. Registers in the study of pediatric rheumatic diseases–limitations and potential. J Rheumatol 1996;23(11):1834–7.PubMedGoogle Scholar
  38. 38.
    Goldstein SL, Somers MJ, Brophy PD, et al. The Prospective Pediatric Continuous Renal Replacement Therapy (ppCRRT) Registry: Design, development and data assessed. Int J Artif Organs 2004;27(1):9–14.PubMedGoogle Scholar
  39. 39.
    Code of Federal Regulations 21.310.305. Food and Drugs. New Drugs. Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.Google Scholar
  40. 40.
    Code of Federal Regulations 21.314.80. Drugs. Post-marketing reporting of adverse drug experiences.Google Scholar
  41. 41.
    Code of Federal Regulations 21.600.80. Biological products. Post-marketing reporting of adverse experiences.Google Scholar
  42. 42.
    FDA Report, May 1999. Managing the Risks from Medical Product Use: Creating a Risk Management Framework. Available at http://www.fda.gov/oc/tfrm/riskmanagement.html.
  43. 43.
    Office of Drug Safety, Food and Drug Administration. Available at http://www.fda.gov/cder/ODS/default.htm.
  44. 44.
    MedWatch form 3500A. Available at http://www.fda.gov/medwatch/report/hcp.htm.
  45. 45.
    Medical product safety information. MedWatch. The FDA safety information and Adverse event reporting program. Available at http://www.fda.gov/medwatch/safety.htm.
  46. 46.
    Chin J. Biotechnology's special forces: Field-based medical science liaisons. J Commercial Biotechnology 2004;10(4): 312–18.CrossRefGoogle Scholar
  47. 47.
    Malecha S, Spears JB, Sylvestri MF. Managing medical liaisons. Strategies in an evolving environment. DIA Forum 2003;39(3): 18–21.Google Scholar
  48. 48.
    Morgan DK, Domann DE, Collins GE, Massey KL, Moss RJ. History and evolution of field-based medical programs. Drug Info J 2000;34(4):1049–52.Google Scholar
  49. 49.
    Schneider BA. Maximizing your investment–The MSL force. DIA Forum 2004;40(4):28–30.Google Scholar
  50. 50.
    PhRMA Code Calls for Changes in Drug Marketing: A Newsmaker Interview with John T. Kelly, MD, PhD, Aug. 9, 2002. Medscape Medical News 2002.Google Scholar
  51. 51.
    OIG Compliance Program Guidance for Pharmaceutical Manufacturers. Office of Inspector General, Department of Health and Human Services. Fed Reg 2003;68(86): 23731–43.Google Scholar
  52. 52.
    Higgins D, Goize S. OIG Draft Compliance for Pharmaceutical Companies. Health Law Reporter 2002;11(41):1–7 (BNA Professional Information Center Health Care).Google Scholar
  53. 53.
    Wolin MJ, Ayers PM, Chan EK. The emerging role of medical affairs within the modern pharmaceutical company. Drug Info J 2001;35(2):547–55.Google Scholar
  54. 54.
    Salter FJ, Kramer PF, Palmer-Shevlin NL. Pharmaceutical industry medical communications departments: regulatory and legal perils and pitfalls. Drug Info J 2000;34(4):1009–15.Google Scholar
  55. 55.
    Werner AL, Murray KM. Preparing for a product launch in a medical communications department. Drug Info J 2000;34(4): 1021–33.Google Scholar
  56. 56.
    Werner AL, Poe TE, Graham JA. Expanding medical services to internal customers. Drug Info J 2000;34(4):1053–61.Google Scholar
  57. 57.
    Begg C, Cho M, Eastwood S, Hood R, Moher D, Olkin J. Improving the quality and reporting of randomized trials. JAMA 1996;276:637–9.CrossRefPubMedGoogle Scholar
  58. 58.
    Anonymous. Thousands served. Pharmaceutical Executive Medical Education Supplement, August 2004:42–43.Google Scholar
  59. 59.
    Herman R, Schonbachler D. PhRMA Code: new rules, same game. Pharmaceutical Executive Medical Education Supplement, August 2004:10.Google Scholar
  60. 60.
    Code of Federal Regulations 24.1001.952(d). The personal services and management contracts safe harbor.Google Scholar
  61. 61.
    Raineri BD. Focus on feedback. Pharma can still have advisory meetings–in some ways, even better than before. Pharmaceutical Executive Medical Education Supplement, August 2004:27–34.Google Scholar
  62. 62.
    Optrompke J. Navigating US conflict-of-interest rules when commercializing research. Nature Biotechnology 2004; 22(7):921–3.Google Scholar
  63. 63.
    Anonymous. The AMCP format for formulary submissions, version 2.1. J Managed Care Pharm 2005;11(5 Supplement): 1–29.Google Scholar
  64. 64.
    Anonymous. A winded FDA races to keep up with drug ads that go too far. USA Today 2005;May 31:1A, 4A.Google Scholar
  65. 65.
    Morris L. The risk management mandate. Pharmaceutical Executive 2004;24(5):98–110.Google Scholar
  66. 66.
    Ruchlin HS. New directions in pharmacoeconomic research: The next step. Drug Info J 2002;36(4):909–17.Google Scholar
  67. 67.
    Kim J, Morris CB, Schulman KA. The role of the Food and Drug Administration in pharmacoeconomic evaluation during the drug development process. Drug Info J 2000;34(4):1207–13.Google Scholar
  68. 68.
    Bootman JL, Townsend RJ, McGhan WF. Principles of pharmacoeconomics. Harvey Whitney Books Co., Cincinnati, OH, 1991.Google Scholar
  69. 69.
    Santell JP. Projecting future drug expenditures–1996. Am J Health Syst Pharm 1996;53(2):139–50.PubMedGoogle Scholar
  70. 70.
    Neumann PJ, Claxton K, Weinstein MC. The FDA's regulation of health economic information. Health Aff (Millwood) 2000;19(5):129–37.CrossRefGoogle Scholar
  71. 71.
    Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, Rothman M. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000;9(8): 887–900.CrossRefPubMedGoogle Scholar
  72. 72.
    Marra CA, Levine M, McKerrow R, Carleton BC. Overview of health-related quality-of-life measures for pediatric patients: application in the assessment of pharmacotherapeutic and pharmacoeconomic outcomes. Pharmacotherapy 1996;16(5): 879–88.PubMedGoogle Scholar
  73. 73.
    Armstrong EP, Abarca J, Grizzle AJ. The role of pharmacoeconomic information from the pharmaceutical industry perspective. Drug Benefit Trends 2001;13(3):39–45.Google Scholar
  74. 74.
    Legg RF, Sclar DA, Nemec NL, et al. Cost benefit of sumatriptan to an employer. J Occup Environ Med 1997;39(7):652–7.CrossRefPubMedGoogle Scholar
  75. 75.
    Evens RP, Flynn J, Mapes D. Preventing the pitfalls in planning phase IV clinical trials: a biotechnology experience. Drug Info J 1996;30(2):583–91.Google Scholar
  76. 76.
    PhRMA. Principles on conduct of clinical trials and communication of clinical trial results. 2003. Available at http://www.phrma.org/publications/publications//2004–06-30.1035.pdf.
  77. 77.
    Report to congress. Reports on postmarketing studies [FDAMA 130]. Available at http://www.fda.gov/cber/fdama/pstmrktfdama130.htm.
  78. 78.
    Evens RP, Sylvestri M, Boone S. Medical affairs for biotechnology/ pharmaceutical start-ups: strategies for launch (research and medical communication). R&D Strategy Session, Drug Information Association 2005 Annual Meeting, June 27, 2005, Washington, DC.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Ronald P. Evens
    • 1
  1. 1.University of FloridaFL

Personalised recommendations