Off-Label Promotion — The Elephant in the Room Understanding the Regulatory and Product Liability Concerns of FDA/DOJ Enforcement

Held June 16, 2011

Off-label promotion is illegal — that’s a well known fact.

What you might not know is that your firm could face significant product liability (and other) lawsuits because of off-label violations.

Here’s how to educate your staff about the regulatory, legal and product liability pitfalls of off-label promotion.

If your company loses a product liability lawsuit, it could cost thousands (even millions) of dollars.

It could also cost you your job.

This is not mere scare talk. The Justice Department has been working on 200+ investigations of off-label violations involving some 500 products. And the FDA’s Office of Criminal Investigations (OCI) maintains a special prosecutions staff to look into illegal off-label promotion of approved devices and drugs.

Yet far too many drug and device company employees simply don’t know the rules. Training is spotty, sometimes nonexistent.

Here’s how to learn what you need to know.

Mark your calendar for Thursday, June 16, when a recognized authority on product liability issues shows how to protect your company — and yourself — from fines, lawsuits, even prison time.

Using case studies as illustrations, attorney Sara Dyson will discuss the issues concerning off-label promotion. By the end of this intensive 90-minute webinar, you’ll have the toolkit you need to head off violations in your workplace.

Here are just a few things you’ll discover:

  • Off-label use and promotion — what it is, how to avoid it
  • Traditional and nontraditional causes of action related to off-label promotion
  • 2 major defenses against liability
  • The FDA’s Good Reprint Practices guidelines on off-label product uses
  • Penalties for off-label violations
  • Illegal promotion vs. “scientific information exchange” — what’s legal, what’s not
  • High-profile cases in which drug/device firms have been held liable (or not)
  • The “Practice of Medicine” exemption — its strengths and weaknesses
  • Best practices for managing off-label promotion risks
  • Tips on creating an effective off-label compliance program
  • And much more

Off-Label Promotion is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

Of course, Ms. Dyson will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.

Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break your budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

With both the Justice Department and the FDA snooping around, it simply doesn’t make sense to risk an off-label violation. Protect your company — and yourself. Sign up today for this timely learning event.

Top management, compliance officials, regulatory and legal staff are certain to want to sign up, as well as advertising, marketing, sales and more. Here’s a list of suggested attendees to choose from –

  • Compliance Officers
  • Executive Management
  • General/Corporate Counsel
  • Regulatory/Legislative Affairs Professionals
  • Risk Management Specialist
  • Sales and Marketing Personnel
  • Training Personnel
  • Medical Science Liaisons
  • Outside Attorneys

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Sara Dyson Esq. is assistant VP for loss control of Medmarc Insurance Group, a provider of product liability insurance to the life sciences industry. She performs risk evaluations of life sciences companies and recommends tailored risk management solutions. She is responsible for developing educational resources in product liability, risk management and related specialties, including FDA compliance and regulation, post-market surveillance, product safety and recalls. Ms. Dyson earned her law degree from the University of Wisconsin and is a member of the Wisconsin and Virginia Bars.

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