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

Venue: Virtual

Location: Virtual, United States

Event Date/Time: May 21, 2009
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Description

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?

Sign up now for this 90-minute webinar 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.

Sign up 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

Venue