Posted 17 June 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) today released two guidance documents focused on the use of social media by members of regulated industry, including one on how companies can use the social media platform Twitter and other space-limited platforms.
The issuance of guidance on social media was required by the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 1121 of which calls for FDA to, by August 2014, "issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA]."
For members of industry, the allure is relatively straightforward. As social media networks like Facebook, Twitter and Instagram have proliferated and become popular, opportunities have emerged to reach out to those users and members of specific communities to market a drug or answer questions.
However, the varied capabilities of the platforms represent myriad problems. For example, it is difficult to contain all the information about a product in a single 140-character tweet. FDA has sanctioned a company in the past for "liking" an unapproved claim on its Facebook wall. And even hidden metadata can be grounds for FDA finding a claim to be misbranded.
With so many questions left unanswered on how to appropriately use the platforms, industry has clamored for guidance from the agency, guidance that now appears to be forthcoming.
But while industry long believed that FDA's thinking on social media would be contained within a single guidance document, FDA quietly announced in January 2014 that it would instead by launching several guidance documents on social media topics, including character space limitations, the appropriate use of links, and sponsor corrections of misinformation.
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.
New Guidance Documents
Now FDA is out a new social media draft guidance document, Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.
Unlike the initial social media guidance document, the new guidance (and another released today on misinformation) have been co-signed by all of FDA's major regulatory centers, including its drug, biologics, veterinary and device divisions. The first guidance had been signed onto by the first three, but not FDA's Center for Devices and Radiological Health (CDRH).
The Twitter Guidance
The first draft guidance could be called the Twitter Guidance owing to its focus on character limitations—something the microblogging social network is famous for. However, while FDA mentions Twitter by name in the introduction to the guidance, it also notes that the guidance is applicable to online paid search products, such as Google and Yahoo's sponsored links.
But at the outset, FDA indicates that it won't be taking a lenient approach toward either tweets or sponsored links. Any information provided, no matter how brief, will need to incorporate risk information within the same character-space-limited communication, FDA wrote.
In other words, companies won't be able to send out a series of tweets containing the full benefit-risk information of a product, but will instead need to contain all information in a single tweet—or more likely, not at all.
'Accurate and Non-Misleading'
As FDA adds later in the guidance, the accuracy of the benefit and risk claims is also an important factor. "Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication," FDA wrote. This could prove problematic for all but the simplest drugs. Many drugs don't have broad approvals for a given disease, but rather specific carve-outs. For example, many obesity drugs don't simply treat obesity, but rather obesity in patients above a specific BMI and with prior health conditions.
FDA also said each character-limited communication should contain "material facts about the use of [the] product, such as limitations to an indication or the relevant patient population."
Good luck doing so in 140 characters or less.
"If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message," FDA continued.
Major Departure from Existing Practice
Much of the remainder of the guidance goes into how companies should include risk information in either tweets or sponsored links.
Here, FDA takes a significant departure from prior practice. FDA writes:
"The Agency believes that a concise disclosure of specific risk information may be presented together with benefit information within the confines of character-space-limited Internet/social media platforms if supplemented by a prominent reference to the presence and location elsewhere of a more complete discussion of the risks associated with the product (or for restricted-device advertising, a “brief statement” of intended use and relevant risk information) and that this is consistent with requirements of the FD&C Act and FDA’s implementing regulations (see section II). These concepts are further elucidated below in this section of the guidance document.
Frequent readers of the Office of Prescription Drug Promotion's (OPDP's) Untitled Letters will recognize this to be significant, as the office regularly chides companies for doing this in website or print promotions. For example, in a recent letter, OPDP wrote:
"We note that the statement “Click here for full Prescribing Information” (emphasis original) is included on the webpage. However, this does not mitigate the misleading omission of risk information."
FDA said that for the purposes of social media, though, this type of activity will be acceptable so long as risk information is presented together with the benefit information.
On Including Serious Risks
FDA also wrote that that all tweets or sponsored links should include, "at a minimum … the most serious risks associated with the product."
That statement could be a death knell for companies with riskier products, and especially those with boxed ("black box") warnings, fatal or life-threatening risks or contraindications. Medical devices will be held to a slightly different standard, as will veterinary products.
FDA's guidance also weighs in on URL-shortening services, saying it does "not intend to object" to their use, but encourages the shortened URL to denote the type of information contained within. For example, a shortened URL might read "www.sho.rt/DrugRisk." URLs should not contain claims, FDA added.
It also won't object to the use of recognized symbols (e.g. "&"), the use of punctuation (";") to break up information, or the use of scientific abbreviation.
So what does an FDA-approved tweet actually look like? FDA provided one case study:
"A firm is considering promotion of its prescription drug NoFocus on Twitter, which is limited to 140 character spaces per message or tweet. NoFocus is indicated for mild to moderate memory loss. There are no boxed or other warnings and no known fatal or life-threatening risks included in the PI for NoFocus. The most serious precaution associated with NoFocus is that it may cause seizures in patients with a seizure disorder. Since benefit information was provided within the tweet (example 1A), the firm should communicate, at a minimum, the most serious risks associated with NoFocus within the same tweet. The firm should also include within the same tweet a direct hyperlink to a more complete discussion of risk information about NoFocus. Additionally, the prominence of risk information should be comparable to the benefit information contained within the tweet, taking into consideration any formatting capabilities that may be available."
That would yield the following Tweet, FDA said:
NoFocus (rememberine HCl) for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk [134/140]
In another case, FDA said an appropriate sponsored link might look like the following (formatted for Google):
Headhurtz (ouchafol) [20/25]
www.headhurtz.com [17/ 35]
For severe headache from traumatic brain injury [47/ 70]
Boxed warning [13/25] - Potential for brain swelling [28/35]
Warning [7/25] - Potentially fatal drug reaction [31/35]
Warning [7/25] - Life-threatening drop in heart rate [35/35]
Risk information [16/25] - Important safety information [28/35]
The takeaway for most companies: Unless you have a safe drug with a clearly defined patient population and a very short proprietary and generic drug name, Twitter might not be a platform you'll get much use out of.
Comments on the draft guidance are due to FDA in 90 days.
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (FR)