In January 2014, the US Food and Drug Administration (FDA) released the first of what it said would be many guidance documents intended to clarify the use of social media by life sciences companies. Now the life science industry is weighing in on that draft guidance, calling for changes and clarifications.
Background: Social Media and FDA
The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FTC), the latter of which has vested its advertising review authority with FDA.
Each advertisement must contain a variety of elements, including facts backed up by substantial and cited evidence, a full accounting of risks, a "fair balance" of benefits and risks of the drug, the generic name of the drug, any serious warnings such as Black Box warnings and more.
The amount of information required, in other words, is extensive.
So how are companies to marry the extensive information requirements of traditional advertising, like television and print media, with emerging social media platforms used by billions? Take Twitter's 140-character limit, for example: Could a company compose even a single tweet that contained all the elements required by FDA? Should it even try?
At stake is nothing less than access to consumers in the new media environment, one in which those consumers are increasingly eschewing television and magazines for YouTube and Facebook.
But while the industry has much at stake, FDA regulators have far less at stake, and have long delayed the release of any guidance on the subject. But in 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) came into law, and with it Section 1121, which requires FDA to, by August 2012, "issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA."
In January 2014, FDA revealed that it would not just be releasing one social media guidance document-it would be releasing several of them, each dedicated to a single facet of the social media landscape: "Issues with character space limitations, links (the appropriate use of links), and sponsor correction of misinformation about their products disseminated by third parties."
As Focus observed at the time, while that means industry gets to mull over some guidance from FDA immediately, it could be months or years before it gets all the pieces of FDA's social media guidance.
Background: New Guidance in Brief
On 13 January 2014, FDA released the first draft of one of its guidance documents, Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.
In brief, the guidance is intended as a guide for companies to illustrate how they can submit materials-and specifically those posted on social media like blogs, microblogs, social networks, podcasts and forums-for review by FDA.
At present, companies are supposed to submit advertising and promotional documents to FDA through Form FDA-2253 (human) or 2301 (veterinary) "at the time of initial dissemination," allowing FDA the opportunity to review materials more proactively instead of being forced to track them down themselves.
But as FDA concedes in the guidance, "at the time of initial dissemination" isn't always practical, especially when communications are being conducted in "real time," such as on Twitter. Should a company have to submit real-time reports for each tweet it sends out? And could FDA cope with the deluge of such information if industry was required to do so?
FDA says it intended to exercise "enforcement discretion" when it would not be feasible to review communications at the time of dissemination, and will instead allow "real-time" communications to be submitted to the agency on a monthly basis. What does not have to be submitted are screenshots of conversations. FDA said URLs to the firm's social media account would meet its reporting requirements so long as access to the social media site remains unrestricted. If the site is restricted, screenshots must be used instead.
Communications will need to be reported if they are "under the control or influence of the firm," such as a tweet by an employee or a group paid by the company to tweet on its behalf.
Industry Weighs in
Now members of the pharmaceutical industry have begun to weigh in on the guidance, submitting more than a dozen comments to FDA in support of and opposition to the new guidance.
For example, the pharmaceutical industry trade group PhRMA wrote that it had "two fundamental concerns with the draft guidance." The first, it said, was that FDA assumes that companies maintain full control over third-party entities publishing on third-party websites. "This premise is overbroad and is inconsistent with the Federal Food, Drug and Cosmetic Act (FD&C Act)," PhRMA wrote.
It went on to call the matter of influence a "nebulous" concept rife with potential conflicts. To quote one section in its entirety:
"For example, if a firm invites all comments about its prescription medicine on a firm-owned bulletin board, will it be deemed to have influenced all of the subsequent posts? If a firm acknowledges users' posts or thanks users for their comments on a firm-owned site, will a firm be deemed to have influenced potential user generated comments in response? Indeed, given the ambiguous nature of the term ―influence, what is the likelihood that a firm could make a statement or actively participate on social media in communication about one of its medicines without being perceived to somehow indirectly or intangibly affecting someone's response?"
Ultimately, even if a firm previews a message that will be sent by a third party, that fails to establish that the message is fully (or even partially) attributable to the company, PhRMA argued.
The second problem identified by PhRMA is that the guidance "erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising," it wrote. "This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment," it wrote.
PhRMA also called on FDA to implement quarterly, rather than monthly, reporting requirements.
BIO: Labeling Clarification Needed
The Biotechnology Industry Organization (BIO), meanwhile, addressed the guidance more from a labeling perspective, calling for FDA to clarify when a social media post mentioning a product is and is not labeling.
At issue are a number of legal cases, among them Kordel vs. United States, which found that labeling can be taken to mean materials that supplement or explain an article. Thus, even if marketing materials do not physically accompany a drug product, it can still be regulated by FDA as labeling. However, BIO argues that subsequent court decisions found that the mere mention of a drug product does not make an article a label; rather, it depends on the context-the "function served by the writing."
BIO said the guidance does not address this topic with sufficient nuance.
"Accordingly, as a predicate matter, when FDA considers the final guidance and future guidances, the Agency should clarify that the appropriate definition of "labeling" is found in 21 U.S.C. § 321(m), the general regulatory definition of labeling in 21 C.F.R. 1.3(a), and relevant case law," BIO wrote.
BIO also mirrored PhRMA's comments in calling the influence provisions of the guidance "overly broad" and likely problematic in that influence does not necessarily mean a degree of control.
BIO, while thanking FDA for its flexibility in reporting schedules, requested that companies be able to adhere to their own reporting schedules based on the frequency of their social media updates and the "activity of the site," especially if posts are less frequent than once per month. A quarterly reporting basis would be preferable in some situations, it said. The guidance might also be helped by clarifying how reports should be annotated, "given that most submissions only require providing static content."
Other Industry Stakeholders Weigh In
Several other industry stakeholders weighed in, including Novartis, which mirrored PhRMA and BIO's comments regarding the "influence" provisions of the guidance.
The company cited one example in which it might direct a third-party entity to avoid placing an advertisement in an area (such as a general medical website) where it might suggest that its product could be used for an off-label purpose. Novartis said this activity should be regarded as "responsible," but said it doesn't necessarily imply that the company holds any "influence" over the third party-just that it is acting as a good steward of its product.
Pfizer, too, said it was "concerned about the interpretation of FDA's authority to regulate manufacturer speech suggested in the draft guidance." The company said the guidance suggested that FDA has the authority to regulate "all product communication" on social media, and advanced an argument similar in scope to the one noted by BIO. The guidance reflects a "jurisdictional creep" by FDA, Pfizer wrote.
Eli Lilly, meanwhile, addressed some concerns that were raised when FDA cited a company for "Liking" an unapproved claim on Facebook. The guidance proposes a definition of "interactive" media, which Eli Lilly says needs to be clarified. Interactive media, the company argued, should involve text. While "Liking" or "Favoriting" a status on Facebook or Twitter might involve an interaction, it should not be taken to mean an interactive communication, Lilly wrote. The same should go for "retweeting" content on Twitter, the company said.
All comments can be read in FDA's social media guidance docket.