Devices & Diagnostics

What legal authority does FDA have to regulate medical device promotions on social media?

Given that most medical devices are not restricted, a crucial question is whether promotion on the Internet is “labeling” or “advertising.” If the former, then FDA has authority to regulate them.

By Jeffrey K. Shapiro

FDA is authorized by the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) to regulate the labeling of all medical devices and the advertising only of “restricted devices.”  (21 U.S.C. §§ 352(a), 352(q) and (r).)  FDA does have authority to take the advertising of non restricted devices into account in determining intended use (21 C.F.R. § 801.4), but it does not otherwise have authority to regulate their advertising. 

FDA creates restricted devices in two ways.  One is by issuing regulations designating particular device types as restricted.  Only two such regulations are on the books, one for hearing aids and the other for analyte specific reagents (ASRs).  (21 C.F.R. § 801.420; id. § 801.421; id., § 809.30.)  

The other way for FDA to create restricted devices is by embedding such designations in orders granting premarket application (PMA) approval to Class III devices.  (21 U.S.C. §§ 360e(d)(1)(B)(ii), 360j(e).)  Since FDA does so routinely, it is fair to say that virtually all Class III devices that have received PMA approval are restricted.

Accordingly, no Class I or Class II devices are restricted except for hearing aids and ASRs. Additionally, the handful of remaining Class III preamendment devices are not restricted, because they are not subject to a PMA approval order.

What does this discussion have to do with the Internet?  Given that most devices are not restricted, a crucial question is whether promotion on the Internet is “labeling” or “advertising.”  If the former, then FDA has authority to regulate them.  (21 U.S.C. §§ 321(n), 352(a) & 352(f); 21 C.F.R. § 801.109(d).)  If the latter, then FDA lacks such authority.

In the early years of the new century, FDA resisted calls to declare whether the Internet was labeling or advertising.  As it turns out, the Internet enables communication in a variety of ways as it continues to evolve.  At the turn of the century, for example, web sites were predominant and various social media platforms that are ubiquitous today (e.g., Twitter, Facebook) had not yet been developed or had not taken hold.  So it turns out that FDA was prudent to resist calls for a sweeping determination as to whether the Internet as a whole would be considered labeling or advertising for regulatory purposes.  It is quite likely that different areas of the Internet could be considered labeling or advertising depending upon their nature and functionality, and new judgments may be required as the Internet continues to evolve.

In keeping with this wait and see approach, FDA has issued no Internet specific regulations and few such guidances.  Last June, however, FDA did issue two draft guidances focused on social media platforms on the Internet.  The first draft guidance discussed presentation of risk/benefit information on internet based social media platforms with character space limitations (“Character Space Guidance”).  The other one concerned efforts by firms to correct third party misinformation on these platforms (“Misinformation Guidance”).  We blogged about these draft guidances here.

The Character Space Guidance is focused on “electronic/digital platforms that are associated with character space limitations – specifically on the Internet and through social media or other technological venues” (p. 1).  As examples, FDA cites Tweets on Twitter and online paid search, such as sponsored links on search engines such as Google and Yahoo (id.).

The Misinformation Guidance is less exacting about the venue.  It applies to “information . . . created or disseminated by independent third parties on the Internet or through social media or other technological venues . . ., regardless of whether that misinformation appears on a firm’s own forum or an independent third party forum or website” (p. 1).  Such venues may include Internet/social media platforms that allow for real time interaction or those where communication is asynchronous (see id., p. 3).

In Section II of each draft guidance, there is a summary of FDA’s authority over device and drug labeling and advertising, and it is generally consistent with the scheme described above.  In particular, FDA expressly notes that it has authority over the labeling of all medical devices and the advertising only of restricted devices. 

The draft guidances do not, however, take the obvious next step and analyze whether the portions of the Internet under discussion are labeling or advertising.  Interestingly, Section VI of the Character Space Guidance provides examples applying drug advertising requirements to tweets and sponsored links, among others.  The Section VI discussion, therefore, could be read to imply that FDA considers at least some aspects of the Internet covered by the draft guidances to be advertising.  Another hint at FDA’s position in the Character Space Guidance, p. 4, n.9, which “encourages” firms selling non restricted devices to follow the guidance, implying that such devices may not be subject to it.

What comes through most clearly, however, is that FDA has declined to forthrightly state its position.  This coy approach is unfortunate, because the answer is crucial to whether the enforcement position in these draft guidances applies to most medical devices. 

It is one thing to refrain from general pronouncements on the status of the Internet as a matter of prudence.  It is quite another to fail to answer an obvious question implicated by a draft guidance directed at a specific portion of the Internet (i.e., social media platforms).  Having chosen to provide guidance with respect to social media platforms, FDA should have indicated whether they consider these portions of the Internet to be labeling or advertising.

Absent such guidance, this blog post will try to answer the question.  This task requires some guesswork, because the statute and regulations have not been updated for the Internet.  But the alternative is complete confusion about whether the draft guidances apply to non-restricted medical devices.

Under the FDCA, “labeling” means “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”  (21 U.S.C. § 321(m).)  As FDA notes in the draft guidances, “accompany” has been read broadly for more than half a century to include materials that textually supplement or explain an article, even if not physically attached to it.  Kordel v. United States, 335 U.S. 345, 350 (1948).

The FDCA does not define advertising, but FDA long ago adopted a regulation giving examples of promotion that would be considered advertising:  “Advertisements [subject to the FDCA] . . . include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.”  21 C.F.R. § 202.1(l)(1).  (The regulation nominally applies to drugs, but FDA has long considered it applicable to devices as well.  It is not clear exactly what was intended by the intriguing reference to advertisements broadcast through “telephone communication systems.”)

Obviously, these examples were provided prior to the development of the Internet and social media platforms.  But an “advertisement” generally means:  “A notice or announcement in a public medium promoting a product, service, or event or publicizing a job vacancy” (emphasis added).  This definition is consistent with the examples provided in the regulation, e.g., placing an advertisement in a print journal or running a radio advertising spot are both ways in which a product may be promoted in a public medium.

The next subsection of the same regulation also provides examples of labeling:  “Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints. . . .”  21 C.F.R. § 202.1(l)(2).  In these cases, rather than placing a notice or announcement in a public medium being used for a variety of messages, such as a newspaper or radio channel, it would appear that the message and the medium are essentially coterminous, and the sponsor disseminates it to the prospective customers.  A brochure, for example, would typically consist entirely of a sponsor’s discussion of its products, and would be disseminated by the sponsor as a handout or mailer.

When a sponsor promotes a device with a tweet, or as a paid link on Google search results, which of these archetypes does such messaging most closely resemble?  What about if the sponsor posts a reply to misinformation about its products on a public bulletin board?

One could argue that these activities most closely resemble advertising.  A paid link on a Google search results page seems much like a traditional advertisement, with the search results page taking the place of a classified advertising in a newspaper.  A sponsor issuing a tweet or posting a reply to a statement in a chat room is also essentially making an announcement in a public medium.  That is the classic definition of advertising.  However, Internet technology does tend to break down the pure separation of labeling and advertising.  For example, a tweet could link to a product brochure that is itself labeling (and, therefore, should comply with the requirements for labeling). 

Still, it is not unreasonable to see social media platforms as a kind of digital public square into which a sponsor steps in to promote its medical devices.  If this view is accepted, then such communications are advertising.  Accordingly, the draft guidances would not apply to non restricted medical devices (i.e., almost all Class I and Class II devices).

It may be that FDA would disagree with this analysis.  Rather than allowing uncertainty to persist, FDA should state its position openly.  It would also be helpful for Congress to update the existing statutory authority for the Internet age.  That would allow FDA to develop a considered policy, as opposed to the somewhat arbitrary exercise of extrapolating the existing statutory and regulatory definitions to new Internet technology – or worse, avoiding discussion of the issue altogether.

Hyman, Phelps & McNamara's attorneys counsel and assist HPM clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA and other regulatory agencies.

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