Off-Label Information Dissemination: Minimize Legal and Regulatory Exposure
Product Details
ALERT:
Despite numerous off-label settlements, new cases are being announced — and now congressional investigators are focusing on whether or not the sales practice of “bundling” products may result in off-label violations.
The Justice Department continues to work on more than 150 investigations — involving up to 500 products — of pharmaceutical companies for alleged off-label violations. Focusing on small companies and even “pure” off-label cases where there is no evidence of kickbacks or harm to Medicare or Medicaid, the government is broadening its enforcement efforts.
How can you minimize the risk of being investigated for an off-label promotion violation?
Led by noted attorney Alan Minsk, who will examine the numerous laws that apply to off-label promotion. He’ll describe the issues to consider when interacting with healthcare professionals, and will provide 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 is and what it is not
- 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