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Area of Science:

  • Pharmaceutical policy and regulation
  • Health economics and outcomes research
  • Managed care pharmacy practice

Background:

  • The Food and Drug Administration Modernization Act (FDAMA) Section 114 permits biopharmaceutical companies to share health care economic information (HCEI) for formulary decisions.
  • Despite its intent, Section 114 has seen minimal promotional use over 17 years, prompting stakeholder discussions on revisions.
  • Recent interest in Section 114 is driven by comparative effectiveness research, big data, diverse data sources, and evolving regulatory interpretations.

Purpose of the Study:

  • To inform managed care decision-makers about Section 114 of FDAMA and industry communications under its provision.
  • To review the regulatory history, impact, and limited utilization of Section 114.
  • To explore reasons for renewed interest and stakeholder suggestions for updating Section 114.

Main Methods:

  • Synthesis of the regulatory history and statutory language of FDAMA Section 114.
  • Analysis of changes to promotion regulations influenced by Section 114.
  • Exploration of factors contributing to the section's limited use and recent resurgence of interest.

Main Results:

  • FDAMA Section 114, intended to facilitate HCEI dissemination, has been underutilized promotionally.
  • Managed care pharmacists need to understand Section 114's restrictions on HCEI communication.
  • Stakeholder recommendations and evolving research trends are driving proposed changes to Section 114.

Conclusions:

  • Managed care pharmacists play a crucial role in shaping the future of HCEI communication under FDAMA Section 114.
  • Clear communication of information needs by the managed care pharmacy community can foster collaboration for transparent information exchange.
  • Updates to FDAMA Section 114 could enhance the transparent dissemination of HCEI, supporting informed formulary decision-making.