Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management

This course will provide necessary information to those in the drug and device manufacturing industries on how to best work with consumers and health professionals regarding off-label claims of relevant drugs and devices that arise from third parties or from the natural progression of social media.

Why Should You Attend:

The government takes drug and device off-label promotion seriously. In the recent (May 7th) plea bargain by Abbott Laboratories, for unlawfully making off-label claims of its drug Depakot, the company agreed to pay $1.5 billion to resolve both the criminal and civil litigation. In another case in New York, an individual who was convicted of the crime of misbranding has raised a defence citing the Freedom of Speech under the First Amendment, but no decision has been announced by the court yet. The outcome may have a major impact on off-label promotions of drugs and devices based upon free speech. 

Areas Covered in the Seminar:

• What drug and device labeling is and is not.
• What the law of off-label promotion of drugs and devices is.
• How freedom of speech and the First Amendment may be important.
• Why drug and device firms favor off-label communications.
• Earlier FDA Guidance regarding off-label communications to learned intermediaries.
• Changes that occurred to off-label communications with the onset of the Internet.