Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean?

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Off-Label Drug Promotion after Amarin
What Does the FDA Settlement Mean?

The FDA has historically taken a firm, restrictive stance on drugmakers’ communications about off-label uses of their products. But, the agency’s position has become increasingly uncertain as the courts address the subject of freedom of “commercial speech.”

Now with the FDA settlement agreement with Amarin, other drugmakers are wondering what this means for them. Is this an “Amarin only” issue or does it have broader implications?

Find out in the management report Off-Label Drug Promotion after Amarin. The report will cover the following:

  • How and why the rules have evolved from 2008 to the present day

  • When does distributing information become promotion?

  • Essential dos and don’ts for distributing scientific articles

  • Why the “safe harbor” turned out not to be so safe

  • How and why off-label rules have evolved from 2008 to the present day

  • Pivotal court cases and how they’ve shaped the law

Order your copy of Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean? today and stay on top of the FDA’s latest rules on what speech is and is not protected.

 

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Who Will Benefit

  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff

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