Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
The FDA issued a guidance document in a question-and-answer format regarding how drug and device manufacturers communicate with payors, formulary committees, and similar entities.
This guidance affects drug and medical device manufacturers, specifically personnel in regulatory, legal, and medical affairs responsible for communicating with health care economic stakeholders.
This document likely provides a framework for the dissemination of information to entities responsible for population-based healthcare decisions. It suggests a structured approach to addressing common inquiries, which may reduce the risk of non-compliant communications during the formulary selection and reimbursement process. The procedural nature indicates a focus on the mechanics and boundaries of these technical exchanges.
Regulatory and legal teams should review existing communication protocols for payor interactions to ensure they align with the Q&A format provided. Internal teams should standardize the presentation of information to formulary committees to maintain compliance with these procedural expectations.
Guidance for Industry and Review Staff - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, Procedural
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