By Kate Greenwood
[Cross-posted at Health Reform Watch]
Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June: Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Both guidances have drawn criticism from industry and observers, with the FDA being charged with, in the words of Pharmaguy at the Pharma Marketing Blog, “not being technically savvy enough to understand the nuances of social media and search engine advertising.”
In the draft guidance on social media platforms with character space limitations, such as Twitter and sponsored links on Google and Yahoo, the FDA states that “if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.” The draft guidance would allow companies to limit the risks that are presented within a character-and-space-limited communication to those that are the most serious, as long as the communication also includes a direct hyperlink to a destination (for example, a landing page) that is devoted exclusively to a complete discussion of the product’s risks. The FDA emphasizes in the draft guidance that “[i]f an accurate and balanced presentation of both risks and benefits is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion).” In the first round of comments, PhRMA commented that the amount of information that companies are required to include in a single communication “would make the use of Twitter and comparable platforms impossible in all but the rarest cases.” With regard to sponsored links, PhRMA also noted that the guidance assumes that advertisers have more control than they in fact do over “the appearance – and order of appearance – of information on such platforms.”
It will be interesting to see whether and how the FDA responds to these comments, as well as to any additional comments filed during the period that comments are reopened, which ends on October 29th. If the agency holds the line (as I think it should) and continues to require that companies provide at least some balance between risks and benefits in all advertising and labeling, regardless of platform, companies will no doubt (continue) to look for alternatives.
At several points in the draft guidance on social media platforms with character space limitations, the FDA notes that “reminder” promotion “that calls attention to the name of a drug or device but does not, among other things, include indications, dosage recommendations, or other representations or suggestions concerning safety of effectiveness,” are exempt from the federal Food, Drug and Cosmetic Act’s risk disclosure requirements. Advertiser Simon Bein writes:
Reminder ads in paid search see some of the highest click through rates of any type of search ad and aren’t bursting at the seams with safety warnings. But when it comes to Twitter, the reality is more sobering: a reminder ad-based Twitter profile is probably about as boring as could be.
Disease awareness advertisements or labeling “that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device” are likewise exempt from the FDCA’s risk disclosure requirements. Bein writes:
If your consumers are high in the funnel—searching for disease state information—unbranded communications, which drive great engagement for many of our clients, will be key. They’re relevant to a consumer’s information-seeking activities and help develop ongoing dialogues with the consumers. And with Twitter, let’s be realistic: branded accounts numbered in the single digits. Unless the FDA has a change of heart, it’s sure to stay that way.
In a recent article in The Pink Sheet, Sarah Karlin makes a similar point, noting that “disease-awareness ads could be a powerful marketing tool in areas of confined space and regulatory uncertainty[.]” Disease awareness ads are not without their issues, though. Karlin reports that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee, both of which recently voted in support of a narrower indication for testosterone-replacement therapy, were concerned by the FDA’s lack of regulation of disease-awareness advertisements for age-related “Low-T”. The committees were shown a television advertisement run by AbbVie, the manufacturer of AndroGel, that says:
Feeling like a shadow of your former self? Don’t have the hops for hoops with your buddies? Lost your appetite for romance? And your mood is on your way down. You might not just be getting older. You might have a treatable condition called low testosterone or Low-T. Millions of men 45 or older may have Low-T. So talk to you doctor about Low-T and step out of the shadows.
Karlin explains that the advertisement “points viewers to a website, www.IsItLowT.com, which like the TV ad doesn’t mention any product name but does contain a page on available treatment options such as gels, patches and injections.” AbbVie does disclose its involvement with www.IsItLowT.com, albeit in the far right hand corner of the site, in gray text against a slightly lighter gray background. Companies are not required to make such disclosures and, in fact, doing so creates some degree of legal risk for them. Per a decade-old draft guidance, there are circumstances under which “the mere appearance of the company’s name in conjunction with a disease reference could trigger the act’s advertising or labeling requirements[.]“
Karlin goes on to report that the advisory committee members, understandably, “wanted to know how a company could discuss symptoms in a disease-awareness ad and imply treatment was available for these symptoms, when testosterone-replacement products weren’t approved to treat these symptoms.” In response, an FDA official emphasized that the agency does not have jurisdiction over such advertisements, the Federal Trade Commission does.
Particularly in character-space-limited platforms like Twitter, disease awareness advertisements merit FDA scrutiny, to ensure that they do not trigger the FDCA’s requirements, and the FTC’s scrutiny as well, to ensure that, if the FDCA does not apply, the advertisements are truthful and not misleading.