FDAnews Announces Device Off-Label Promotion Webinar, Nov. 12

Share Article

FDAnews, in conjunction with Ann Walsh, currently a Hyman, Phelps & McNamara director — formerly FDA’s former Associate Chief Counsel within the Office of Chief Counsel — and associate Allyson Mullen, have developed a device off-label compliance plan that will keep devicemakers off the FDA’s radar.

FDAnews

FDAnews

“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 FDAnews webinar leaders Ann Walsh and Allyson Mullen.

Device Off-Label Promotion
Squarely On FDA’s Radar Screen
**FDAnews Webinar**
Nov. 12, 2013 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DeviceOffLabel

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 — on Tuesday, Nov. 12. The occasion: an exclusive webinar from FDAnews.

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, the speakers will show precisely what the FDA looks for when reviewing promotional claims. Attendees will 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 much more

The 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 promotions don’t run afoul of FDA standards.

Register now

WHO WILL BENEFIT
Here’s a suggested list of potential participants from your organization:

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

Conference Details
Device Off-Label Promotion
Squarely On FDA’s Radar Screen
**FDAnews Webinar**
Nov. 12, 2013 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DeviceOffLabel

Tuition
$547 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register
Online:     http://www.fdanews.com/DeviceOffLabel
By phone: 888-838-5578 or 703-538-7600

ABOUT FDANEWS
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
since: 12/2011
Like >
FDAnews

Visit website