Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally.
In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be responsible for large plaintiffs` verdicts in products liability cases that arise from the off-label uses of their products.
The pharmaceutical industry has been distributing reprints of scientific and journal articles on off-label uses of drugs for many years now, but the regulations and rules in recent years were burdensome, and the Department of Health and Human Services Office of the Inspector General (OIG) has been diligently pursuing off-label promotion as a form of Medicare fraud. In February 2008, the FDA issued guidance that permits the dissemination of medical and scientific journal articles. This guidance places regulatory constraints on how information can be disseminated and limits the types of materials that can be distributed.
Why you should attend: This presentation will address both the regulatory and products liability consequences of off-label promotion. It discusses the fundamentals of off-label promotion and provides risk management tips to help companies prevent off-label promotion.
Areas Covered In the Seminar: - Off-Label Use of Drugs
- Overview of Current Legislation and Regulations
- Recent Legal Actions
- Pros and Cons to Permitting Off-Label Dissemination of Information
- Recent FDA Guidance - Good Reprint Practices
- Leveraging Requirements for Validation
Who will benefit: - Quality and Compliance
- Legal
- Sales and Marketing
- Medical Affairs
- Human Resources
