The US FDA Modernization Act (FDAMA) of 1997 contains a provision, Section 114, stipulating the conditions under which drug companies can promote health economic information to formulary decision makers.
The motivation was to provide drug companies greater flexibility to promote healthcare economic information (HCEI) (e.g. claims that a drug saves money or is cost effective). Most notably, Section 114 amended the evidentiary standard for HCEI promotion from the prevailing “adequate and well-controlled trials” (commonly referred to as “substantial evidence”) to the new “competent and reliable scientific evidence.”
The Section also codified other limits, namely restricting promotion of HCEI to “formulary committees or similar entities” (thus barring promotion of HCEI under the “competent and reliable” standard to individual physicians or consumers). Any promotion of HCEI directly to physicians or consumers must adhere to the conventional “substantial evidence” provision, which generally means two adequate and well controlled clinical trials. Section 114 also states that such promotion must be “directly related” to the labeled indication.
Despite its potential importance, little is known about how the Section has been interpreted and used. In a new paper, my colleagues and I report on a small 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.
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.
The survey thus 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 FDA is needed.
More clarity – and, ideally, flexible interpretation – from the FDA is warranted, especially given the rise of CER.
- Peter J. Neumann
1. Neumann PJ, Lin PJ, Hughes TE. US FDA Modernization Act, Section 114: Uses, Opportunities and Implications for Comparative Effectiveness Research. Pharmacoeconomics. 2011 Aug 1;29(8):687-92
[Research supported for the study was provided by Eli Lilly and Company. Publication was not contingent on Eli Lilly and Company’s approval. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Eli Lilly or others.]