Friday, July 11, 2008

Be careful in the federal maze of medical marketing regs

You did it. Your company has just been notified by the FDA that your medical device has been given clearance to proceed to market. But wait: What measures do you take to ensure that your team is not running afoul of the FTC over advertising or of the FDA over labeling and promotion? The U.S. Food and Drug Administration has traditionally been responsible for approving labels and labeling of drugs, foods and medical devices. In 1938, Congress vested the authority over advertising to the U.S. Federal Trade Commission without much guidance as to the definition of advertising. Advertising can include advertisements in journals, magazines, newspapers and advertisements broadcast through multiple media such as the Internet.

Due in part to direct-to-consumer advertising, the FDA is responsible for all prescription drug advertising but has some authority to regulate the advertising of “restricted medical devices,” which are those sold via a licensed health-care provider. Other medical device advertising is regulated by the FTC. The FDA does cast a broad net over the definition of “labeling,” but promotional materials or Internet marketing has come into the purview of the FTC as do over-the-counter drugs. As part of the latest round of FDA amendments in 2007, the FDA and FTC have stepped up enforcement of advertising of new medical products, drugs and food.

Be mindful of this regulatory maze to avoid having the FDA term your product to be “misbranded” under its labeling authority or having the FTC term your product’s marketing activities to be “false” or “misleading” advertising.

The company must stay within the boundaries of what its “intended use” was when it was either cleared under a 510(k) or approved for use under a premarket approval. Focusing and reminding yourself of the “intended use” and the claims allowed by the FDA will help keep your company in compliance. Use a reprinted clinical trial study at a trade show or on your website, but do not draw conclusions of safety, editorialize or exaggerate — that may be promoting an “offlabel” use of your product.

When establishing your website, the FDA and the FTC care about what you say and how you say it. Press releases and investor relations materials may be overly optimistic and may suggest or promise an outcome of the product that is not yet approved. An overstatement of claims without telling the whole story may result in a finding of “false and misleading” advertising.

Using anecdotal patient testimonials based upon a clinical impression may lead to a promotional shortfall that can get you into hot water. One patient’s experience may not be every patient’s experience, and it may appear to be suggesting a new indication for use for the product with no supporting data that has not yet approved or cleared by the FDA. Since the Internet is worldwide, any company using it as a promotional tool must be in compliance with U.S. regulatory guidelines. A company should clearly outline which products are available for use within the U.S. versus those not available within the U.S. to avoid any “off-label” use claims.

Don’t despair, and go looking for a career in the financial services industry. Establish a program to review and update the website, marketing materials, and presentations. Make sure that you know what your marketing partners — which include physician advocates — are saying about your product. Temper your staff’s enthusiasm before the regulators dampen your spirits and add cold water to your sales forecasts.


 

Karin Gregory is a managing partner at Furman Gregory LLC, a Boston-based company offering business and legal counsel to startups. She can be reached at karin@furmangregory.com.