Off-Label Drug Promotion - Webinar CD/Transcript

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Off-Label Drug Promotion: FDA’s Recent Enforcement in the Product Promotional Arena

The FDA allows manufacturers to engage in off-label communications under certain circumstances including: responses to unsolicited requests — through sponsorship of continuing medical education events where off-label uses are discussed — peer-reviewed journal articles — medical texts — and clinical practice guidelines containing off-label information.

Recently, the FDA’s authority to restrict off-label communications has been successfully challenged in a series of court decisions suggesting that companies may distribute truthful — non-misleading information — about off-label uses of their products without violating the FDCA.

On Nov. 9-10, 2016 the FDA held a public hearing on manufactures ability to communicate information about unapproved uses of medical products that have at least one approved or cleared indication — or “off-label communications.”

Legal expert Alan Minsk — of Arnall Golden Gregory — discusses the FDA’s latest rules on what speech is and is not protected.

In this 1-hour session you will learn about:

  • FDA’s enforcement against pre-approval promotion
  • The PhRMA/BIO principles on sharing truthful and non-misleading information
  • FDA's recent public hearing on off-label communications
  • Non-FDA-related issues to consider with off-label promotion
  • A look ahead to where might we be headed

Order today and learn about how you can promote off-label uses of your drug while remaining compliant with FDA regulations.

  • 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

Alan G. Minsk is a partner and leader of the Food and Drug Practice Team at Arnall Golden Gregory. Mr. Minsk focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the FDA.