CURRENT USES OF AND PERCEPTIONS ABOUT FDAMA SECTION 114

Author(s)

Lin PJ1, Hughes TE2, Neumann PJ11Tufts Medical Center, Boston, MA, USA, 2i3 Innovus, Carmel, IN, USA

OBJECTIVES: Section 114 of the 1997 U.S. Food and Drug Administration Modernization Act (FDAMA) stipulates the conditions under which drug companies could promote health economic information to health care plans.  This study examined current uses of and perceptions about Section 114. METHODS: We conducted a web-based survey of a convenience sample of 59 experts representing pharmaceutical companies and academia.  We asked about their interpretation of, and experiences with, Section 114, as well as their views regarding the FDA issuing further guidance to advise pharmaceutical companies on making promotional economic claims to payers. RESULTS: Thirty-three of the 59 experts (56%) completed the survey.  Among pharmaceutical company health outcomes directors, 81% stated they always or frequently consider using Section 114 when making promotional claims for drugs, but 63% stated they were unclear about how to effectively create, approve or use Section 114 information.  The reasons for not using Section 114 included:  not feeling comfortable using the Section (25%); the fact that economic value information not included in the product label (13%); and uncertainty about whether creating a Section 114 piece was worth the benefit (13%).  75% expected to use Section 114 to a greater extent in the future.  75% of outcomes director and 88% of academic experts stated that the FDA should issue guidance on Section 114, especially regarding what qualifies as “health care economic information” and “competent and reliable scientific evidence.”  69% of outcomes directors and 65% of academic experts agreed that the increased focus on comparative effectiveness research would increase Section 114 use. CONCLUSIONS: Pharmaceutical companies are considering and using FDAMA Section 114 to make promotional economic claims for drugs, despite their diverse interpretations of the law.  Direction from the FDA may clarify how companies could share a range of comparative economic information with health plans.

Conference/Value in Health Info

2011-05, ISPOR 2011, Baltimore, MD, USA

Value in Health, Vol. 14, No. 3 (May 2011)

Code

PHP104

Topic

Health Policy & Regulatory

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways

Disease

Multiple Diseases

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