Off-Label DTC Advertising Will FDA Be Forced to Allow It?
In what has been described as a “surprise move” (see below) the FDA recently published a Federal Register notice announcing that it will hold a 2-day public hearing November 9-10, 2016, to obtain input on issues related to off-label communications by manufacturers regarding FDA-regulated drugs and medical devices. FDA says it is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/ cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.”

What’s even more surprising is that FDA is asking questions about off-label direct-to-consumer (DTC) and direct-to-patient communications in addition to the typical questions about such promotions directed at physicians.

This article summarizes the First Amendment assault on FDA’s ability to regulate off-label communications.

Topics (partial list):

  • A Brief History of Off-Label Promotion
  • Chart: 25 Years of Pharma Criminal and Civil Penalties
  • First Amendment Challenges
  • Is the Battle Lost?
  • A Slippery Slope
  • Cancer Off-Label DTC May Be First Case?
  • Has It Already Happened?
  • Duke Chimes in on Off-Label Drug Promotion

Download the full article (PDF file) here:

In a Surprise Move, FDA Will Hold a Public Meeting to Review Off-label Marketing

Issue: Vol. 15, No. 4: September 2016

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