MX Magazine, December 2005

In all of the excitement about the online consumer marketplace for medical device companies, FDA compliance is a question that continually arises. Understanding of exactly which regulations apply specifically to online consumer advertising by device companies has been somewhat elusive. This is justifiable, for it is an intriguing, if not murky, subject, and, on the part of FDA, very definitely a work in progress.

What We Know

No FDA-related statutes or regulations specifically address issues involved in Internet advertising. However, in 2004, FDA's Center for Devices and Radiological Health (CDRH) issued a draft guidance document dealing with medical device advertising.1 This guidance document deals with consumer-directed broadcast advertising of restricted devices, and focuses on promotion conducted via telephone, television, and radio. Despite the fact that the guidance does not specifically address Internet content, the agency may well seek to apply it to that medium. According to Deborah Wolf, regulatory counsel in the CDRH Office of Compliance and a coauthor of the guidance, FDA regulations generally do not distinguish among audiences.

Medical device companies are subject to all of the statutes and rules that apply to consumer advertising and labeling, says Wolf. Moreover, the Federal Food, Drug, and Cosmetic Act establishes additional requirements under the sections on labeling (352(a)) and restricted device advertising (352(q) and 352(r)).2

"Even without any Internet-specific requirements, companies are responsible for the material that appears on their Web sites," says Wolf.

What We Don't Know

"Regarding Web site promotion, there are no specific rules or FDA guidelines, and the same policies apply as with any other type of labeling or advertising," says Sandra Dennis, a partner in the FDA/healthcare regulation practice of the law firm Morgan, Lewis & Bockius (Washington, DC). One major difference between Web site promotion and broadcast is the unlimited space on the Internet. There is no need to limit the information provided to the consumer, as there is with television or radio."

Peter Pitts, a senior fellow at the Pacific Research Institute (San Francisco) and a former FDA employee, cites a number of compelling issues regarding Internet-based consumer marketing. He believes that sound social science research will enable Internet advertising to be better understood, and that it is necessary so that such advertising can be regulated in the interest of public health.

"Internet advertising has the potential to reach many more people than traditional mass media," says Pitts, who is also senior vice president for global health affairs at Manning Selvage & Lee (New York City). "It reaches people in different demographic and psychographic profiles. That being the case, more people will receive more messages that are more relevant to them and, as a result, will be more compliant with their treatment regimens."

Pitts notes with irony the reason for the lack of FDA Internet regulations. "Like so many regulators, some people at FDA prefer ambiguity over predictability," he says. "Rather than draft new guidelines that help companies do the right thing, FDA prefers to use its judgment—unlike in almost every other area of FDA jurisdiction, where science calls the shots."

In a nutshell, says Pitts, FDA needs congressional support in order to carry out the appropriate regulatory measures.

"They have a lot on their plate. They are understaffed and overworked. It's the unfortunate reality. Pitts concludes: "If Congress really wants FDA to do a better job, then ‘show me the money.'"

References

1. Consumer-Directed Broadcast Advertising of Restricted Devices, draft guidance (Rockville, MD: FDA, Center for Devices and Radiological Health, Office of Compliance, 2004).
2. U.S. Code, vol. 21, sect. 352 (1976).

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