Off-Label Promotion: Record-High Settlements Have the FDA and DOJ Wanting More

Held May 21, 2009

ALERT: Fines and settlements are at an all-time high for off-label violations … the federal government has collected nearly $12 billion in fines by prosecuting healthcare fraud over the past 10 years.

HURRY, this event is taking place very soon!

The Justice Department is working on more than 200 investigations — involving up to 500 products — of pharmaceutical companies for alleged off-label violations. The government is broadening its enforcement efforts and is focusing on small companies, even “pure” off-label cases where there is no evidence of kickbacks or harm to Medicare or Medicaid.

To make matters even more confusing, the FDA has issued new rules allowing companies to distribute off-label information in medical journals even though the articles may promote product usage not approved by the agency.

How can you minimize the risk of being investigated, facing mammoth fines and losing your right to sell to Medicare for an off-label promotion violation?

Order now for now for this 90-minute audio CD/Transcript led by noted attorney Alan Minsk and listen in as he examines the numerous laws that apply to off-label promotion. He will explain the issues to consider when interacting with healthcare professionals and will detail strategies to address and minimize the risk of these violations.

Order now for your entire team to listen in and discover:

  • How to minimize the risk of a government investigation into sales and marketing practices
  • A no-nonsense explanation of what off-label promotion is and what it is not
  • How to navigate the latest rules on distributing information via medical journals
  • How the False Claims Act, anti-kickback laws, PDMA and other laws relate to off-label marketing
  • What the “red flags” are for government enforcement — gleaned from recent court decisions and prosecutions
  • The threat of qui tam actions and how to prevent them
  • Best practices for ensuring that interactions with healthcare professionals are fully compliant — what you should and shouldn’t say 

Have the strategies in place to help avoid huge fines, criminal prosecution or other penalties!

This audio CD/Transcript is a must for positions in drug, biotech, biologic, device and diagnostics companies, including:
  • Compliance officers
  • Executive management
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • 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

Alan Minsk is partner and chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP. He advises pharmaceutical and medical device companies on all legal and regulatory matters relating to the FDA and certain matters concerning numerous other governmental agencies. Alan counsels, speaks and writes on a wide variety of FDA-related issues, including product promotion and advertising, FDA enforcement, market exclusivity, FDA inspections, regulatory strategy and life cycle management and much more.

Order now!