Device Off-Label Promotion

Device Off-Label Promotion - Webinar CD/Transcript

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Device Off-Label Promotion: Squarely On FDA’s Radar Screen

Devicemaker TranS1 (now known as Baxano Surgical) has agreed to pay $6 million to settle allegations it knowingly promoted its AxiaLIF System for uses not approved or cleared by FDA.

“As the number of potential drug-company targets dries up due to FDA having taken enforcement action against the largest of them, the device industry likely now is in the crosshairs,” say two Washington lawyers with deep roots in the medical device community.

Ann Walsh and Allyson Mullen of Hyman, Phelps & McNamara have developed a device off-label compliance plan designed to keep devicemakers off the FDA’s radar.

They’ll share this plan — along with visuals of the actual violating promotional materials that drew the CDRH’s ire.

CDRH recently created a new group within the Office of Compliance devoted to labeling issues. It’ll surely result in increased focus on device advertising and promotion, say FDA-watchers.

Off-label violations by devicemakers can get expensive fast.
A unique FD&C Act provision — only applicable to devicemakers
— allows the government to recover civil monetary penalties.

Using first-hand experience gained serving in the Office of Chief Counsel, your speakers show precisely what the FDA looks for when reviewing your promotional claims. You’ll discover:

  • Visual examples of device promotional materials that drew FDA sanctions
  • Tips for pre-reviewing ads and promotions to assure they’ll meet FDA requirements
  • How the FDA reviews promotional materials and what thresholds it allows
  • Lessons from the mistakes of other devicemakers
  • Best labeling-strategy practices to meet regulatory requirements
  • And muchmore

Your co-presenters bring a wealth of enforcement savvy — from both sides of the fence.

Anne Walsh joined Hyman Phelps in January 2011 as a director, following service as Associate Chief Counsel with the FDA Office of Chief Counsel (2004-2010). Previously, she served pharmaceutical and medical-device clients at a major international law firm. Ms. Walsh brings an invaluable perspective, having negotiated on both sides of the table on FDA-related matters.

Allyson Mullen is an associate at Hyman Phelps. Previously, she handled corporate legal and regulatory affairs work for Waters Corporation and served in a regulatory affairs role for devicemakers Boston Scientific and DePuy.

That $6 million settlement you read about above? It could be just the beginning. Make sure your promotions don’t run afoul of FDA standards.

  • Medical device regulatory affairs and legal officers
  • Advertising and promotion compliance professionals
  • Marketing team members
  • Outside advertising and promotion teams

Meet Your Instructors

Anne Walsh joined Hyman Phelps in January 2011 as a director, following service as Associate Chief Counsel with the FDA Office of Chief Counsel (2004-2010). Previously, she served pharmaceutical and medical-device clients at a major international law firm. Ms. Walsh brings an invaluable perspective, having negotiated on both sides of the table on FDA-related matters.

Allyson Mullen is an associate at Hyman Phelps. Previously, she handled corporate legal and regulatory affairs work for Waters Corporation and served in a regulatory affairs role for devicemakers Boston Scientific and DePuy.