On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to inform FDA’s “comprehensive review of its regulations and policies” pertaining to such communications. The FDA poses a number of specific questions to stakeholders, covering such topics as:

  • How increased communications from firms about unapproved uses could impact public health
  • How do changes occurring in the health care system that give payors and formulary committees more influence on prescribing decisions (including by denying, limiting, or endorsing coverage of unapproved uses of approved medical products) incentivize firms to generate the high-quality data needed to demonstrate safety and effectiveness for new uses?
  • What standards should apply to unapproved use communications to minimize the potential for such communications to be misleading or otherwise cause harm?

The FDA also welcomes any other pertinent information from interested parties.