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| Jeffrey Shapiro |
An attorney whose practice is focused on medical device law has called into question the FDA's authority to regulate devices that are promoted on social media platforms like Facebook and Twitter.
Jeffrey Shapiro, writing in his firm's FDA Law Blog, cited the agency's power to regulate the labeling of all devices and the advertising for restricted devices. However, he writes, the agency does have the authority to take the advertising of nonrestricted devices into account in determining intended use. Beyond that, though, the FDA doesn't have the authority to regulate the advertising of nonrestricted devices.
If you're not confused by now, throw in tweets, likes, Google Adwords, search engine optimization and this past year's attempts by the FDA to clarify its policies on the use of social media by medical device and drug companies. That was supposed to have been done back in July with the release of draft guidelines that have most marketers in pharma scratching their heads. The medical device industry has waited cautiously on the social media sidelines and watched as it changed how the world communicates.
Shapiro, like many observers, has been flustered by the FDA's grappling with the guidelines.
"What comes through most clearly, however, is that FDA has declined to forthrightly state its position," Shapiro wrote. "This coy approach is unfortunate, because the answer is crucial to whether the enforcement position in these draft guidances applies to most medical devices."
In issuing guidance on social media platforms, he said, the FDA failed to indicate whether it considers them (social media platforms) to be labeling or advertising. If you see social media platforms as a digital public square where a company can promote its medical devices, then such communication would be advertising. In that case, Shapiro said, the draft guidances wouldn't apply to nonrestricted medical devices, which would include almost all Class I and Class II devices.
"It may be that the FDA would disagree with this analysis," Shapiro wrote. "Rather than allowing uncertainty to persist, [the] FDA should state its position openly."
Obviously, the debate over the agency's draft guidelines continues. Presumably, most of it via social media platforms. Hopefully, FDA clarification comes before we get our jet packs, because Apple ($AAPL) gave us our Dick Tracy watches last month.