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US FDA Modernization Act, section 114: uses, opportunities and implications for comparative effectiveness research
Peter J Neumann1, Pei-Jung Lin, Tom E Hughes
1Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA.
Pharmacoeconomics
|July 8, 2011
Summary
Pharmaceutical companies frequently use Section 114 of the FDA Modernization Act for drug promotion. Increased comparative effectiveness research (CER) is expected to boost its use, with a call for FDA guidance.
Area of Science:
- Pharmaceutical Marketing
- Health Economics
- Regulatory Affairs
Background:
- Section 114 of the 1997 US FDA Modernization Act (FDAMA) enables pharmaceutical companies to promote drug economic value to formulary decision-makers.
- Limited understanding exists regarding the interpretation and application of Section 114.
Purpose of the Study:
- To investigate pharmaceutical industry professionals' interpretation and use of Section 114.
- To explore views on the FDA's role and the impact of comparative effectiveness research (CER) on Section 114 promotions.
Main Methods:
- A web-based survey was administered to 35 outcomes directors in major pharmaceutical and biotechnology companies.
- Questions focused on Section 114 interpretation, usage experiences, FDA's role, and the influence of CER.
Main Results:
- 46% of surveyed experts (16/35) responded.
- 81% frequently consider using Section 114 for drug promotion.
- 75% desire FDA guidance on "healthcare economic information" and "competent and reliable scientific evidence."
- Most anticipate increased future use of Section 114, particularly with the rise of CER.
Conclusions:
- Awareness and some utilization of Section 114 for drug promotion are evident among industry professionals.
- There is a consensus that CER will drive greater use of Section 114.
- The need for clearer, flexible FDA guidance on Section 114 is emphasized, especially in the context of growing CER.
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