If pharmaceutical and medical device companies are eagerly awaiting the US Food and Drug Administration's (FDA) social media guidance for promoting their products using social networks like Twitter and Facebook, a new guidance released by the US Federal Trade Commission (FTC) may provide some insight into how the agency will treat mobile and social advertising.
FTC and FDA operate under a slightly unusual agreement in which FTC voluntarily cedes some of its authority to regulate advertising to FDA in the understanding that FDA regulators have a better understanding of the nuances of the safety and efficacy claims made by companies.
That understanding, first put into practice in 1958 and updated in a 2009 memorandum of understanding, gives FDA the "primary responsibility" for drugs, devices and cosmetics when they are misbranded or otherwise advertised falsely.
However, FTC maintains responsibility for the truth or falsity of all advertising of products (other than prescription drugs), including medical devices.
New Media, New Problems
As digital practices have evolved, so too have questions regarding what constitutes misbranding on certain social media channels. For example, would a company be required to actually list major side effects in a 140-character twitter message, or could they simply link to a webpage outlining risks? Could a Facebook "Like" of an approved claim otherwise not containing all relevant information constitute misbranding?
As FTC notes in its guidance, "new issues arise almost as fast as technology develops," which isn't to say putting the words "social media" into the fray means companies should be held to a different standard.
"The same consumer protection laws that apply to commercial activities in other media apply online, including activities in the mobile marketplace," FTC explained.
Practical Concerns and a New Media Framework
Practically, this means that companies will need to, "when practical… incorporate relevant limitations and qualifying information into the underlying claim, rather than having a separate disclosure qualifying claim." This would seem to rule out the use of micro-blogging platforms like Twitter at first glance, but FTC's guidance goes on to note that the "when practical" clause allows for some leeway.
"When it is not possible to make a disclosure in a space-constrained ad, it may, under some circumstances, be acceptable to make the disclosure clearly and conspicuously on the page to which the ad links," it wrote. In those instances, companies should use a hyperlink to lead to a disclosure, which should meet a six-part test:
- The link should be obvious
- The link should be appropriately labeled regarding the information it leads to (i.e. "Safety Information")
- The link should be stylistically constituent throughout the content
- The link should be as close as possible to the relevant information
- The link should take consumers directly to the disclosure page
- The link needs to be assessed for click-through rates to determine best practices and ways to improve patient use
The very nature of online media should alleviate some old-media concerns, FTC said, as the agency sees websites and mobile applications as "interactive" because they "have a certain depth - with multiple pages or screens linked together and pop-up screens, for example - that may affect how proximity is evaluated."
Mobile devices represent similar but unique issues, FTC said, as disclosures that would ordinarily be seen on the first page of a website-"above the fold," as it is referred in media-can be relegated to a spot much further down on a page, reducing the chances that a consumer would see it.
Accordingly, FTC recommends that qualifying information should be "clear and conspicuous" and as close to the claim as possible. In some cases, text prompts should be used to alert consumers to the additional information.
One example contained within the guidance, a Twitter "advertisement" (Example 14) may provide the clearest example applicable to pharmaceutical and medical device companies.
In the ad, an actress, a paid endorser for a fat loss product, claims that "Fat-away Pills" helped her to lose 30 pounds of weight for an acting role. The verbiage is followed by a shortened hyperlink (maintained by the service bit.ly) containing a disclosure.
The advertisement has a number of issues, FTC said. For one, since the product is available to the public (like an over-the-counter drug product) through general retailers, consumers might not click through to the website containing the disclosure.
In another iteration of the same basic advertisement, the basic risks associated with the product are contained within the ad. Average consumers would lose just one pound per week with the product, it claims-not the five per week experienced by the actress. This model could prove difficult for pharmaceutical marketers, whose list of safety warnings can be measured in pages and not characters, to emulate.
FTC also identified the risks of using Twitter when sending multiple messages. If a company waits too long between messages, consumers might only see an initial statement regarding the product's benefits, and not a subsequent one regarding its risks. FTC stopped short of explicitly saying that this method was banned, though it was singled out as being "problematic."
Companies also need to avoid the use of unobvious "hashtags," used by some users to make certain terms easier to search for. Thus, if a pharmaceutical company were to use Twitter to promote a product and used the hashtag #Spon, for sponsored tweet, consumers might not know what they're referring to.
Shortened links, too, should be obvious for what they are. Thus, a link of "www.bit.ly/4tgfa8" would be far less preferable than one structured like "www.bit.ly/safetywarnings4f."
The question, then, is whether FDA's coming social media guidance will borrow heavily from FTC's guidance, or if it will blaze a more restrictive path entirely.
Under the FDA Safety and Innovation Act, FDA is required to publish its social media guidance by
year's end July 2014, and is coming under increasing pressure from industry to do so. In March 2013, for example, medical device industry group AdvaMed sent a comment to FDA by way of the Federal Register calling on the agency to release to guidance as soon as possible, noting that it had been promised for years.
The agency, however, still has 22 months in which to issue the guidance, leaving plenty of time for it to watch in interest as industry comments on the FTC guidance.
Until that time, the industry is stuck #waiting.