Originally Published MDDI June 2005
Advertising and promoting medical devices requires delicate footing. One misstep and FDA can issue a strong rebuke to a firm. Yet device companies need to let customers know about the latest advancements in medical technology.
So what's a firm to do? Act cautiously, and be sure that science supports every claim being made, said experts at a marketing compliance conference in April.
“Make sure the promotion of your device is clear. You need to have valid scientific data on file,” advised Sandra Cohen Kalter, a partner at King & Spaulding LLP (Washington, DC). Kalter and others spoke on these issues at the conference. The Center for Business Intelligence (Woburn, MA) sponsored the forum, which was held in Washington, DC.
Broadcasting an advertisement isn't as simple as mentioning the device or saying how well it works. For example, the consumer testimonial—a big advantage in most industries—can be dangerous for devices. “Testimonials are a very fertile area for violations, because it's as if the company is making the statement itself,” said Kalter. “In broadcast ads, give consumers a place to get background information, like a toll-free phone number.”
Preapproval promotion is often prohibited. A device with pending 510(k) clearance can be advertised, but a company can't take any orders until FDA approves it. FDA also frowns on comparative claims. Even if an ad states that a device is different from another, FDA sees this as a comparative claim. “Language matters,” said Kalter.
Section 401 of the FDA Modernization Act of 1997 (FDAMA) should have enabled companies to promote new uses for a device. But it hasn't worked out that way because “it's too cumbersome,” Kalter said.
A company can distribute information about a use not described in a product's labeling only under certain conditions. Such conditions include clear disclosure that the information is for an unapproved use. The requirements are so unwieldy that companies just don't want to get caught up in them, she said.
Internet promotion is another sticky subject. While FDA has no guidance on it, the agency considers on-line information to be labeling. “What you link becomes yours,” said Kalter. Companies cannot link to sites that focus on unapproved indications or products. However, an unwritten FDA policy allows a corporate home page to be linked to another corporate page that has information about an approved use in a foreign country, even if the use isn't approved in the United States, said Kalter.
FDA doesn't usually support disclaimers made on the Internet, she said. This can be seen as promoting an unapproved use. She added that it's also a bad idea to link to articles or case studies that talk about unapproved uses. FDA can interpret this as a company's intended off-label use of a device.
Despite all the restrictions and exceptions, FDA warning letters for advertising and promotion have decreased. During fiscal year 2001, CDRH issued 16 warning letters; in FY 2002, it issued just two.
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