PharmacoEconomics

, Volume 29, Issue 8, pp 687–692

US FDA Modernization Act, Section 114

Uses, Opportunities and Implications for Comparative Effectiveness Research
Short Communication

Abstract

Background: Section 114 of the 1997 US FDA Modernization Act (FDAMA) is an important vehicle for pharmaceutical companies to promote the economic value of their drugs to formulary decision makers, but little is known about how the Section has been interpreted and used.

Methods: We conducted a web-based survey of a convenience sample of 35 outcomes directors of major pharmaceutical and biotechnology companies. We asked them about their interpretation of, and experiences with, Section 114, as well as their views regarding the FDA’s role in the matter, and whether the advent of comparative effectiveness research (CER) will affect the use of Section 114 promotions.

Results: Of the 35 experts, 16 (46%) completed the survey. 81% stated they always or frequently consider using Section 114 when making promotional claims for drugs. 75% stated that the FDA should issue guidance on how to make such promotions to payers, especially what qualifies as healthcare economic information and competent and reliable scientific evidence. Most expected to use Section 114 to a greater extent in the future, and agreed that the increased focus on CER would increase Section 114 use.

Conclusions: The survey suggests strong awareness about Section 114 among the outcomes directors and some use of the Section for promotional purposes. It also reflects a belief that CER will increase use of Section 114 promotions, and that guidance from the FDA is needed. More clarity and, ideally, flexible interpretation from the FDA is warranted, especially given the rise of CER.

References

  1. 1.
    Luce BR. CER: a common federal standard? How about a common federal understanding? Bethesda (MD): United Biosource Corporation, 2008Google Scholar
  2. 2.
    Neumann PJ. What ever happened to FDAMA Section 114? A look back after 10 years. Value Health 2009 Mar-Apr; 12 (2): 189–90PubMedCrossRefGoogle Scholar
  3. 3.
    US Food and Drug Administration. DDMAC frequently asked questions. 2009 [online]. Available from URL: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090308.htm [Accessed 2011 Jan 18]Google Scholar
  4. 4.
    Neumann PJ, Zivin Bambauer K, Ramakrishnan V, et al. Economic messages in prescription drug advertisements in medical journals. Med Care 2002 Sep; 40 (9): 840–5PubMedCrossRefGoogle Scholar
  5. 5.
    Palmer JA, Timm AR, Neumann PJ. Drug company advertising in medical journals about the health-economic advantages of their products for 2000–2006 versus 1990–1999. J Manag Care Pharm 2008 Oct; 14 (8): 749–55PubMedGoogle Scholar
  6. 6.
    Ackerly DC, Glickman SW, Schulman KA. Economic content in medical journal advertisements for medical devices and prescription drugs. Pharmacoeconomics 2010; 28 (5): 429–38PubMedCrossRefGoogle Scholar
  7. 7.
    Pharmaceutical Manufacturers Association (PhRMA). Members. 2010 [online]. Available from URL: http://www.phrma.org/about/member-companies [Accessed 2010 Jan 15]Google Scholar
  8. 8.
    MedAdNews. List of biotechnology companies. 2007 [online]. Available from URL: http://en.wikipedia.org/wiki/List_of_biotechnology_companies [Accessed 2010 Jan 15]Google Scholar
  9. 9.
    Garrison Jr LP, Neumann PJ, Erickson P, et al. Using realworld data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health 2007 Sep-Oct; 10 (5): 326–35PubMedCrossRefGoogle Scholar
  10. 10.
    Sullivan SD, Watkins J, Sweet B, et al. Health technology assessment in health-care decisions in the United States. Value Health 2009 Jun; 12 Suppl. 2: S39–44CrossRefGoogle Scholar
  11. 11.
    Gottlieb S, Klasmeier C. Comparative effectiveness research: the need for a uniform standard. Washington, DC: American Enterprise Institute for Public Policy Research, 2009Google Scholar
  12. 12.
    Neumann PJ, Claxton K, Weinstein MC. The FDA’s regulation of health economic information. Health Aff (Millwood) 2000 Sep-Oct; 19 (5): 129–37CrossRefGoogle Scholar
  13. 13.
    Stafford RS, Wagner TH, Lavori PW. New, but not improved? Incorporating comparative-effectiveness information into FDA labeling. N Engl J Med 2009 Sep 24; 361 (13): 1230–3PubMedCrossRefGoogle Scholar
  14. 14.
    Wellpoint. Use of comparative effectiveness research (CER) and observational data in formulary decision making. 2010 [online]. Available from URL: http://www.anthem.com/shared/noapplication/f0/s0/t0/pw_b156827.pdf?refer=ahpprovider [Accessed 2011 April 15]

Copyright information

© Adis Data Information BV 2011

Authors and Affiliations

  • Peter J. Neumann
    • 1
  • Pei-Jung Lin
    • 1
  • Tom E. Hughes
    • 2
  1. 1.Center for the Evaluation of Value and Risk in HealthTufts University School of Medicine, Institute for Clinical Research and Health Policy Studies, Tufts Medical CenterBostonUSA
  2. 2.Market Access and ReimbursementOptum Insight Life SciencesEden PrairieUSA

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