Unsolicited Off-Label Discussion Permissible in Industry-Sponsored Speaker Programs


I was a bit gobsmacked when I read this post by John Flider at Hyman, Phelps, & McNamara.

Based on a recent legal case, he states,

“…a company pays a physician to provide an educational presentation to doctors, the manufacturer is subject to criminal prosecution if that physician affirmatively discusses the off-label use, but the same manufacturer will not be subject to prosecution if the physician provides the same information in response to an audience member’s unsolicited request.”

Free speech is apparently alive and well. We knew that unsolicited requests were a safe harbor for dissemination of off-label scientific information to physicians. This extends, at least in one court of law, the concept of unsolicited requests to oral requests during industry-sponsored physician-to-physician speaker programs.

It is however a tortuous path for pharmaceutical, medical device and diagnostics companies to navigate. As a basic review, be sure to abide by these “thou shalt nots” summarized on the WhistleblowersLaws website:

  • Speakers programs where the choice of speaker is influenced by the marketing or sales department.
  • Speakers programs where the choice of speaker is influenced by the speaker’s prescription writing habits.
  • Selecting speakers absent any investigation of the speaker’s professional qualifications including ascertaining: a) whether the speaker has a bona-fide medical license, b) whether the speaker has published in the area, and c) whether the speaker is under investigation by any regulatory bodies or has been sanctioned, reprimanded, or suspended by any regulatory bodies.
  • Grants to universities, doctors, or medical establishments for research or work where the marketing department of the company had an influence over the grant or funding.

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3 responses to “Unsolicited Off-Label Discussion Permissible in Industry-Sponsored Speaker Programs

  1. Pingback: New Lawsuit Chips Away at FDA’s Unwritten Off-Label Rules | Good Promotional Practices

  2. Pingback: 5 Things You Didn’t Know About Off-Label Sales Compliance | Good Promotional Practices

  3. Pingback: Live Monitoring of Speaker Programs: Expert How-Tos | Good Promotional Practices

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