Congress Seeks a Statutory Fix to Stymied Off-Label DiscussionsMay 2, 2017 Download PDF
Without pomp or circumstance, Congressman Morgan Griffith (R-VA) introduced a bill on March 27,2017, that would expand the communications pharmaceutical and medical device companies can have with doctors about their products. The bill, titled the Medical Product Communications Act of 2017, seeks to clarify the concept of “intended use.”
FDA currently regulates communications about off-label uses on the ground that the discussion of an unapproved use creates a new “intended use” for which the company needs specific FDA approval or clearance.
FDA broadly defines the term “intended use” by regulation, and recent attempts to revise these rules have proven controversial.
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- Anne K. Walsh