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

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.

This webinar will help you in understanding how firms can develop procedures unique to them providing the most effective way to interact in social media affirmatively and positively in order to prevent the dialogue concerning their drug or device from being controlled by third parties, such as a competitor lurking behind a blog or webpage. We will also cover procedures to respond to independent and virtually non-regulated consumer social media that disseminate negative, off-label or controversial claims about their product over the Internet. You will learn how your firm can stay ahead of an ever-changing social media with pro-active information and not be exposed to the risk of additional FDA regulatory/enforcement activity and from a less positive view by the market. We will also discuss how and when to claim freedom of speech when working with off-label claims in the social media.

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.
• The long awaited FDA Guidance explained.
• What the Guidance covers and what it does not include
• Establishing procedures to have a viable and compliant off-label policy.
• Using the developed protocol to follow FDA Guidance on off-label claims.
• The use of risk management in an effective manner to promote off-label claims based upon freedom of speech.

Who will benefit:

The following individuals from drug and device companies will benefit:

• VP, Marketing
• Labeling
• Regulatory Affairs
• IT
• Product Development
• Top management

Instructor Profile:

Charles R. (Bob) McConachie, is a Dallas, Tx attorney. He has practiced food and drug law beginning in 1970 at the Department of Justice where he litigated FDA enforcement and regulatory law cases in federal courts. From 1975 to 1979 he served as Chief of the Consumer Affairs Section, now the Consumer Protection Division of the Civil Division at DOJ. Among other cases he personally argued the case in which the FDA’s decision to remove Red Dye No. 2 from the market by the end of the day was upheld by the DC Circuit.

Topic Background:

The Food Drug and Cosmetic Act prohibits any labeling that is false or misleading in any particular. A violation may be prosecuted as a criminal case. Off-label drug and device claims may constitute such violations.

The Internet as used by the ever-ballooning social media has and is changing how drug and device claims are communicated in ways few contemplated a few years ago. The FDA has been behind the curve in its regulation of off-label social media claims. From hearings in 1996 on the then newly developing Internet the agency did little. Another hearing in 2009 focused on social media use, but again nothing happened. Finally, in late 2011 FDA published Guidance on drug and device firms responding to unsolicited requests by social media regarding off-label claims. The Guidance has been criticized by industry as being inadequate. Having Guidance, even if it is not comprehensive, on this increasingly used form of communication will help allow drug and device firms to establish procedures on how to respond to communications via social media concerning labeling.

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