US FDA Modernization Act, Section 114
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
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.
- Luce BR. CER: a common federal standard? How about a common federal understanding? Bethesda (MD): United Biosource Corporation, 2008
- Neumann PJ. What ever happened to FDAMA Section 114? A look back after 10 years. Value Health 2009 Mar-Apr; 12 (2): 189–90 CrossRef
- 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]
- Neumann PJ, Zivin Bambauer K, Ramakrishnan V, et al. Economic messages in prescription drug advertisements in medical journals. Med Care 2002 Sep; 40 (9): 840–5 CrossRef
- 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): 749–55
- Ackerly DC, Glickman SW, Schulman KA. Economic content in medical journal advertisements for medical devices and prescription drugs. Pharmacoeconomics 2010; 28 (5): 429–38 CrossRef
- Pharmaceutical Manufacturers Association (PhRMA). Members. 2010 [online]. Available from URL: http://www.phrma.org/about/member-companies [Accessed 2010 Jan 15]
- MedAdNews. List of biotechnology companies. 2007 [online]. Available from URL: http://en.wikipedia.org/wiki/List_of_biotechnology_companies [Accessed 2010 Jan 15]
- 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): 326–35 CrossRef
- 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: S39–44 CrossRef
- Gottlieb S, Klasmeier C. Comparative effectiveness research: the need for a uniform standard. Washington, DC: American Enterprise Institute for Public Policy Research, 2009
- Neumann PJ, Claxton K, Weinstein MC. The FDA’s regulation of health economic information. Health Aff (Millwood) 2000 Sep-Oct; 19 (5): 129–37 CrossRef
- 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): 1230–3 CrossRef
- 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]
- US FDA Modernization Act, Section 114
Volume 29, Issue 8 , pp 687-692
- Cover Date
- Print ISSN
- Online ISSN
- Springer International Publishing
- Additional Links
- Industry Sectors
- Author Affiliations
- 1. Center for the Evaluation of Value and Risk in Health, Tufts University School of Medicine, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, 800 Washington St, Box #063, Boston, Massachusetts, 02111, USA
- 2. Market Access and Reimbursement, Optum Insight Life Sciences, Eden Prairie, Minnesota, USA