Mark's Memo: FDA Updates and News Briefs | 10/14/09

Mark Mansour, Partner, Bryan Cave, LLP

Social Media Marketing Is Indispensable, But Rife With Pitfalls

The FDA will hold meetings next month to discuss regulation of Internet and social media promotions for devices, drugs and biologics, but until it develops guidance on the area, marketing experts warn that companies should carefully monitor their online activities, including the content of postings that visitors may leave on their site, particularly if the postings discuss off-label product uses.

Device makers want more protections for collecting off-label data

Industry speakers at last month’s Transcatheter Cardiovascular Therapeutics conference called for the creation of a safe harbor that would allow industry to collect post-market clinical data without fear of being perceived as promoting off-label use. The industry noted concern that breach standards are being determined by the Department of Justice and by the U.S. Attorneys rather than by the FDA or the medical societies. They also discussed the challenges that can arise when in clinical practice a device is used commonly for off-label indications.

FDA issues strategic plan for risk communication

The FDA has issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients, and consumers in the form they need it and when they need it, and for how the agency oversees industry communications. The plan also suggests a study to determine the most effective format and content for communicating information about devices to users and prescribers. The Strategic Plan is available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm183673.htm

FDA issues draft guidance on marketing tobacco products

The FDA is announcing the availability of the draft guidance entitled “The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act.” This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance discusses certain activities that FDA believes do or do not fall within the scope of the prohibition. The guidance is not intended to be an exhaustive analysis of all activities that may or may not fall within the scope of the prohibition. While comments on the guidance may be submitted at any time, comments must be submitted by January 4, 2010 to ensure that the agency considers them before it begins work on the final version of the guidance. More information is available at: http://edocket.access.gpo.gov/2009/E9-23866.htm

Mark Mansour is a partner in the firm, Bryan Cave, LLP