Expect a modest increase in pharmaceutical ads on social media as a result of a new FDA draft guidance document just issued for comment. That’s the expectation of industry observers who hailed the agency’s long-awaited move as “a good start.”
Focused only on FDA’s reporting requirements for ads on “interactive promotional media” (to use the agency’s own terminology), the new document doesn’t go as far as many have been hoping. That could come in July when the 2012 FDA Safety and Innovation Act (FDASIA) requires the agency to “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products” that it regulates.
But for now, observers like APCO Worldwide’s president of regulatory services and healthcare, Wayne Pines, praise the draft guidance for explaining, at last, what FDA holds companies accountable for on the Internet, after years of uncertainty.
“It also helps that FDA expects Form-2253 submissions periodically rather than every single time there is an addition or change on the Internet,” Pines said. “And FDA made clear that it will exercise enforcement discretion in issuing enforcement letters.
“I think that the regulated companies and the media/communications companies were expecting a much more detailed guidance, setting forth what they can and cannot do with social media. However, FDA has said all along that it applies the same regulatory standard to Internet/social media materials that it does to other promotional materials, namely that the claims be supported by substantial evidence and that there be a fair balance of risk information.”
Coalition for Healthcare Communication executive director John Kamp predicts the guidance will produce a modest increase in social media advertising, rather than “open the flood gates.” That’s because, he said, FDA isn’t the only or even the biggest reason for advertiser reluctance—there are lots of other reasons, plaintiffs’ failure-to-warn suits being the biggest.
Kamp especially likes the flexibility FDA is offering in the guidance—companies can report their ads every day if they wish, or adhere to official deadlines.
Most significant to Kamp is that FDA has for the first time committed itself in the document to not holding advertisers responsible for things they don’t control.
FDA’s definition of “promotional labeling” is expansive, and in the new draft guidance it says no physical relationship between the promotional words and the product is necessary. The draft links to examples published in the Federal Register that, while antiquated, include non-printed materials like motion picture films, sound recordings, and “audio or visual matter descriptive of a drug …”
The agency has been elastic and quite imaginative in interpreting this section of its regulations to fit whatever industry comes up with on the Internet.
If it meets the new FDASIA law’s July 9 deadline to elaborate on its policy toward Internet “promotional labeling” of all regulated medical products, look for more details then. Or shortly thereafter.
The document delineates, with examples, how FDA decides that a firm is “responsible” for information disseminated on social media by third parties.
In the case of user-generated content, the draft guidance says FDA will “exercise enforcement discretion” (read: take no enforcement action) if firms participating in such discussions one of five steps: (1) Submit all sites in their entirety on Forms 2253 or 2301 at the time of initial display; (2) in the case of a firm’s interactive or real-time communication on a third-party site, submit the home page, the interactive page and the firm’s first communication on either form at the time of initial display; (3)submit monthly updates of all non-restricted sites for which the firm is responsible; (4) submit all content from restricted sites that is related to the discussion, making sure the report accurately reflects the context; and (5) ensure that site submissions take formatting factors into consideration “to enable the agency to view the communications as a whole.”