2017-01013: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period

Summary

The Food and Drug Administration (FDA) is reopening the comment period for the notification of public hearing, published in the Federal Register of September 1, 2016 (81 FR 60299) concerning our comprehensive review of our regulations and policies governing manufacturer communications regarding unapproved uses of approved or cleared medical products. FDA is also announcing that it has added a document to the docket for the public hearing entitled "Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products" (Memorandum). The Memorandum provides additional background on the issues FDA is considering as part of its comprehensive review, including a discussion of First Amendment considerations. In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of two draft guidance for industry that address manufacturer communications, one entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers," and the other entitled "Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers." FDA is reopening the comment period to provide the public an opportunity to review the Memorandum as it relates to the specific questions and issues identified in the notification of public hearing as well as review the two draft guidances and provide additional or new comments.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 15 Public Hearing Before the Commissioner