The Debate on Off-Label Promotion - Webinar CD/Transcript

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The Debate on Off-Label Promotion: Amarin Ruling

Off-label drug promotion is one of the biggest controversies in pharmaceuticals. With cases like Amarin in the courts, and the FDA announcing a public hearing on the subject this summer, it's not far from the daily headlines.

The Aug. 7 federal court ruling on the Amarin Pharma Inc., et. al v. Food and Drug Administration et. al allows the drugmaker to make statements and disclosures to doctors regarding the use of Vascepa (icosapent ethyl) to treat patients with persistently high triglycerides, even though it lacks FDA approval for that application — as long as the communication is truthful and not misleading.

At FDAnews, we've been thinking about how best to illustrate the different points-of-view on the subject. We decided that a debate would be a great opportunity for both sides — in favor of a looser interpretation of rules on off-label promotion, and against — to provide all the evidence for their positions.

First Amendment Rights?

  • Courts have consistently upheld that the Constitution protects commercial speech, as long as it is not false or misleading.
  • It is a legally dubious overreach for the FDA to presume this speech is false until proven otherwise, and to name themselves sole arbiters of the truth.
  • The traditional approval process is often a costly, cumbersome obstacle to getting timely information to doctors, and thus better — potentially life-saving — medicine to patients.
  • Supposed “safe harbor” rules in guidance lack practical effectiveness, as the FDA refuses to acknowledge them as binding.

Patient Protection?

  • Drug companies’ primary goal is to generate sales.
  • Information on off-label use is not independently reviewed, so manufacturers have little incentive to ensure its accuracy.
  • Studies show the overwhelming majority of off-label promotion lacks strong scientific evidence to support it.
  • Doctors lack time or ability to verify every cherry-picked piece of data that companies send them.
  • The traditional approval process exists for a good reason, and manufacturers are violating the clear intent of the laws set down by Congress.
  • Common-sense exceptions for unusual situations already exist in FDA guidance

Ralph F. Hall
Counsel, Faegre Baker Daniels LLP
Professor of Practice,
University of Minnesota Law School

Ralph Hall has extensive experience in the areas of FDA, health care law and corporate compliance, including the application of regulatory systems to the medical device industry. He has expertise in the design and implementation of regulatory compliance programs and with FDA enforcement actions. Mr. Hall also has experience in developing and implementing cross-disciplinary corporate legal strategies, corporate law department organization and management, and general corporate counseling.

Prior to rejoining Faegre Baker Daniels, Mr. Hall was with Guidant Corporation where he served as Senior Vice President and Deputy General Counsel, Litigation and Compliance. Also at Guidant, he was special counsel to the Board of Director's Compliance Committee and the corporation's Compliance Office. Earlier, he was general counsel of Guidant's Cardiac Rhythm Management Group — a billion-dollar-plus business. Before that, Mr. Hall was with Eli Lilly and Company, where he served in a number of legal roles, including chief environmental counsel.

Mr. Hall serves as a Professor of Practice at the University of Minnesota Law School, where he teaches courses in FDA law, corporate compliance and negotiation.

He has written extensively on FDA and compliance matters, as well as spoken frequently at legal seminars on a variety of subjects.

Timothy Mackey, MAS, PhD
Director, Global Health Policy Institute
Assistant Professor of Anesthesiology and
Global Public Health,
University of California San Diego
School of Medicine

Timothy Mackey is the Director of the Global Health Policy Institute and an assistant professor of anesthesiology and global public health at  University of California, San Diego School of Medicine. He is also the Associate Director for the UC San Diego MAS Program in Health Policy & Law.

He earned his BA in Political Science-International Relations from UC San Diego, a Master’s Degree from the UC San Diego MAS Program in Health Policy & Law, and his PhD in the Joint Global Public Health program with UC San Diego and San Diego State University. He completed an Executive Course in Global Health Diplomacy at the Graduate Institute, Geneva.

Mr. Mackey’s work focuses on a cross-cutting array of multidisciplinary topics in domestic and global public health research, including medicine, international relations, public policy, law, technology, economics and intellectual property, technology environmental health, eHealth, crime, and global governance.

He has acted as a consultant and expert for the World Health Organization and the U.S. Department of State, and has been a term member of the Council on Foreign Relations, a lifelong member of the Bouchet Graduate Honor Society, an associate editor for BMC Public Health, and Co-Chair for the Good Governance in Global Health Project in partnership with University of Toronto. He spent over seven years as senior legal and compliance specialist for ResMed.

The 90-minute debate is based on a modified presidential format.

  • Questions are posed to alternating sides (first determined by coin toss), with three minutes for one side to answer, and two minutes for the other side to give a rebuttal.
  • The moderator may give each side an additional 30 seconds or ask follow-up questions.
  • Each side delivers a two-minute closing statement.
  • Questions were selected from submissions by our journalists — and live audience members

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