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US FDA Modernization Act, Section 114

Uses, Opportunities and Implications for Comparative Effectiveness Research

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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.

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Acknowledgements

Research supported by Eli Lilly and Company. Publication was not contingent on Eli Lilly and Company’s approval. Dr Hughes was an Advisor in Payer Marketing at Eli Lilly and Company when this article was written. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Tufts Medical Center, Eli Lilly and Company or OptumInsight Life Sciences.

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Authors and 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

    Peter J. Neumann (Director) & Pei-Jung Lin

  2. Market Access and Reimbursement, Optum Insight Life Sciences, Eden Prairie, Minnesota, USA

    Tom E. Hughes

Authors
  1. Peter J. Neumann
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  2. Pei-Jung Lin
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  3. Tom E. Hughes
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Correspondence to Peter J. Neumann.

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Neumann, P.J., Lin, PJ. & Hughes, T.E. US FDA Modernization Act, Section 114. Pharmacoeconomics 29, 687–692 (2011). https://doi.org/10.2165/11590510-000000000-00000

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  • DOI: https://doi.org/10.2165/11590510-000000000-00000

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