The Neverending Saga of Off-Label Speech Enforcement Assessed in WLF Seminar

Can the Supreme Court, Congress, or anyone provide an “endgame” to the federal government’s highly lucrative, and at time ludicrous, enforcement efforts against medical device and pharmaceutical companies’ speech about “off-label” uses of their products? This was the subject of an insightful hour-long WLF Web Seminar program today.

ENDGAME?: The Solution to Drug and Device Makers’ Off-Label Problem featured two attorneys who businesses regularly call on when the Food and Drug Administration, federal prosecutors, or private whistleblowers register concerns over so-called off-label promotion, Dr. Paul Kalb and Coleen Klasmeier. Dr. Kalb and Ms. Klasmeier organized their presentation around a PowerPoint presentation, which can be downloaded here.

During the presentation, Ms. Klasmeier discusses one possible “endgame” solution, which she explores in a forthcoming Working Paper, FDA Regulation of Off-Label Promotion: An Answer.

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