AdvaMed Publication Provides Insight on Legal Requirements for Advertising and Promotion of Medical Devices.

Business Editors/Health & Science Writers

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WASHINGTON--(BW HealthWire)--Nov. 1, 2001

Direct from Medical Newswire - The FDA issues warning letters to presidents and CEOs of medical device companies every day.

Frequently, these letters focus on what the FDA deems to be inappropriate advertising and promotional practices.

Medical device companies often find themselves in difficult situations because the FDA has not issued specific guidance on advertising and promotion practices. In almost every promotional situation, whether on their own website or at a trade show, or on third party websites, chat rooms or other types of on-line promotion, medical device companies are left with no guidance on what they can say about new indications or products in development.

Important information on these evolving advertising and promotional requirements was provided in a teleconference "Advertising and Promotion of Medical Devices: FDA and FTC Answer Questions from Medical Device Manufacturers." AdvaMed is providing a transcription of this two-hour teleconference heard by 1300 regulatory and quality assurance affairs professionals in which medical device manufacturers pose 70 questions to FDA and FTC officials. Transcribed and edited by the AdvaMed staff and reviewed by legal and regulatory professionals, this document is formatted into subject areas for easy referencing and will be an invaluable resource for your regulatory, legal, clinical, sales and advertising departments. Included are questions about FDA and FTC jurisdiction, Internet responsibilities, liability in off-label usage, chat rooms, foreign-approved devices and products in development. Included with the transcription is "FDA's Limits on Manufacturer's Dissemination of Truthful Information and Display of Unapproved Medical Devices" written by Hogan & Hartson. It has nine pages of questions and answers, plus 100 pages of warning letters, FR Notices, regulations and guidances.

After reviewing this publication, Ron Dollens, CEO of Guidant Corporation commented, "If you believe there's nothing new about the oversight of advertising and promotion of medical technology by the FDA and the FTC, you should read AdvaMed's publication, which outlines the inherent challenges and limitations in an incredibly efficient format."

Susan Alpert, VP Regulatory Science, C.R. Bard, said, "This one-place reference for answers to common questions and their basis in regulation or guidance is so useful we recommended it for the sales managers as well as the regulatory staff."

Robert H. McCall, Sr. Regulatory Affairs Specialist, Steris Corporation, said, "An exceptional value. The panel discussion gives the reader an insight into the thought processes of both the FDA and FTC regarding promotional advertising."

Mike Santalucia, VP Global Regulatory Affairs, Bausch and Lomb, commented, "This is an invaluable reference for anyone who develops and reviews medical device advertising."

To preview a list of questions, go to www.advamed.org/publicdocs/dec8conferencecall.html, and to see more information on this publication, go to http://www.advamed.org/mtli/#pubs. For more warning letters, see the FDA website, http://www.fda.gov/foi/warning.htm.

Medical Newswire: From the Healthcare Information Center in Washington, D.C. since 1947. To contact Medical Newswire, call 1-800-359-4454 or e-mail [e-mail].