On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (the Memo). The issuance of this Memo coincided with the publication of two related draft guidance documents addressing communications that are consistent with approved labeling and communications with payors – all released in a final flurry of activity before the end of the Obama Administration. FDA has invited comments on the Memo and draft guidances by April 19, 2017.

Background -

The Memo is FDA’s latest step in a series of activities following its 2014 promise to reexamine its regulations, policies, and guidance for off-label communications under the First Amendment – in an attempt “to harmonize the goal of protecting the public health with First Amendment interests.”