CDRH’s Office of Compliance Increases Size of Device Advertising and Promotion Policy Group
Just a week ago, FDA Regulatory Counsel Deborah Wolf announced that CDRH’s Office of Compliance had tripled the size of its Advertising and Promotion Policy Group.
Now truthfully, the staff increase from one to three members pales compared to FDA’s drug center, which employs 60 staffers in a similar role. But device companies should be able to easily read the tea leaves on this move, which should also come as no surprise. For medical device public relations, marketing, regulatory and legal counsel folks, the smoke signals coming from FDA have been clear for some time. Medical device companies will begin to fall under the same type of microscope that the drug industry has been under for some time. This initial staffing increase is likely just the first of more to come as funding becomes available.
And central to the FDA’S more vigorous examination will be the promotion and marketing of off-label usage. It is also our belief that FDA will also be more closely examining the promotion of unfounded claims that lack substantiation in science and lack the approval of FDA. Expect closer examination of Internet-based information, including of course your own Web Site. I recently read of one instance where a company’s web site contained an investor-level presentation by a clinical investigator on the results of off-label studies. The off-label study itself is, of course, perfectly acceptable, but the FDA viewed the posting on the company’s web site as promotional and zing! – off went a warning letter.
If this renewed attention hasn’t already resulted in your company developing and executing a compliance program then you are already behind. A good summary of the issues and components can be found here.
It is vital that your public relations agency and marketing consultants not only be aware of the issues, but have undergone compliance training themselves. We’re proud that our healthcare staff here at Schwartz has, and thus provides another level of security to the healthcare PR pros and marketers who engage us.