Devicemakers wishing to establish a full online presence must take special care to ensure their use of social media doesn’t throw them out of compliance with FDA promotional speech regulations, Edward Basile, with the consulting firm King & Spalding, told a recent session of the FDA/Xavier University MedCon conference here.
To avoid doing so, companies should develop a written policy on use of social media, Basile advised. The policy should cover objectives of online messaging, encouraged and prohibited topics, employee training and participation guidelines, and how to disclose any adverse events.
The key to complying with what little advice the FDA has provided on social media messaging is to stick to discussion of on-label usages only, Basile advised. Social media postings should also include a balanced discussion of risks and benefits and avoid being “false or misleading,” he said. Misleading statements include those that omit relevant content or context, as well as those that are actually untrue, he added. The agency published draft guidance on off-label communications in December.
Last year, the device industry paid the Justice Department close to $1.8 million due to its stepped-up enforcement campaign to curb off-label marketing and violations of the False Claims Act.
How can you minimize the risk of being investigated for an off-label promotion violation and ensure your promotional program is in compliance?
Manufacturers could see a stronger crackdown on off-label promotion according to a March 2012 Office of Inspector General (OIG) report directing HHS to focus on the practice. OIG flagged that issue among others as “weaknesses” with the FDA in its annual report on the top management and performance challenges facing HHS.
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