Life Sciences

Internet promotion subject to FDA review

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 29, 2008

Physicians and patients obtain most of their information about products online, said James M. Wood, JD, a partner at Reed Smith in Oakland, CA.
Wood, speaking at the Regulatory Affairs Professionals Society annual conference in Boston on September 14, said companies need to understand what they can and cannot do online. Off-label promotion, he said, can be the undoing of a product and a company.
“The Internet provides ripe opportunities to push the envelope,” he said.
The FDA issued draft guidance on Internet marketing 12 years ago, but has not provided any guidance since then, Wood said. The agency considers online advertisers subject to the same rules as any other print marketing material.
Medical device manufacturers can advertise online in two ways. Direct promotion, such as corporate Web sites and product-specific Web sites, are an inexpensive way to get information out, Woods said. Companies can also use indirect promotion, such as online journals and disease state information Web sites.
Regardless of which approach a device company uses, Wood said companies must appropriately present the product and treat an internet ad like any other kind of ad.
Internet promotion also presents unique challenges. Companies must ensure information is current. Companies should also be careful about links to other sites, even links to bibliographies and the National Institutes of Health. Companies need to worry about what is posted on the other site, so Wood recommended having someone monitor the links.
Companies should monitor their Web sites to ensure information provides a fair balance and no off-label information, because plenty of other people are willing to report violations, Wood said.


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