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.
In late 2011, the FDA published Guidance on drug and device firms responding to unsolicited requests by social media regarding off-label claims. Because Guidance is not binding law, drug and device firms will continue to have the option to go their own way independent of the new Guidance, but bearing certain additional risk.
Who will benefit:
The following individuals from drug and device companies will benefit:
- VP, Marketing
- Regulatory Affairs
- Product Development
- Top management
Added by complianceonlinecom on June 1, 2012