Draft Guidance for Industry: ``Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)''

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs).'' This document provides guidance to sponsors of regulated medical products (human drugs, biologics, and medical devices) by describing circumstances in which sponsors may be held responsible for promotional activities performed by healthcare organizations or PBM's that violate the Federal Food, Drug, and Cosmetic Act (the act) and regulations issued thereunder. The intent of this draft guidance is to provide clarification and consistency in the agency's regulation of medical product promotion in light of changes in the healthcare environment.