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When Does FDAMA Section 114 Apply? Ten Case Studies.

Peter J Neumann1, Cayla J Saret1

  • 1Tufts Medical Center, Boston, MA, USA.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|August 23, 2015
PubMed
Summary
This summary is machine-generated.

Pharmaceutical companies face uncertainty promoting health economic information due to vague regulations under Section 114. Clearer guidance is needed for compliance regarding evidence of value.

Keywords:
FDAMA Section 114United Statescase studiescompetent and reliable scientific evidencehealth economics

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Area of Science:

  • Health economics
  • Pharmaceutical marketing regulation
  • Health policy analysis

Background:

  • Section 114 of the Food and Drug Administration Modernization Act of 1997 governs pharmaceutical promotion of health economic information to US health plans.
  • Increasing demand for evidence of value necessitates greater regulatory clarity.

Purpose of the Study:

  • To develop hypothetical case studies of health economic promotions.
  • To examine the legal and policy implications of these promotions under Section 114.

Main Methods:

  • Constructed 10 categories of potential health economic promotions for pedagogical purposes.
  • Generated hypothetical case studies for each category to assess compliance with Section 114.
  • Case studies covered diverse areas including cost-effectiveness, burden-of-illness, and extrapolation of trial data.

Main Results:

  • Most health economic promotion scenarios fall into a regulatory "gray zone."
  • Ambiguity exists regarding "competent and reliable evidence" and claims "directly related" to approved indications.
  • Lack of specific guidance makes it challenging to determine permissible activities under Section 114.

Conclusions:

  • The imprecision of Section 114 and limited guidance create practical difficulties for pharmaceutical companies.
  • Future regulatory guidance should aim for increased clarity and flexibility.
  • Addressing these ambiguities is crucial for compliant and effective communication of value.