Putting Together the Pieces on FDA’s Social Media Guidance Josh Baldwin, Vice President, MSLGROUP

The last piece of draft guidance the Agency has committed to releasing this year (though it has already

missed the July 9 deadline set forth in the 2012 FDA Safety and Innovation Act) is related to the use of

links in product promotional content in social media.

A number of industry commentators and media outlets have already covered the details of the latest

FDA social media guidance documents. Rather than reiterate the same points about these two, we’ve

taken a step back and pulled out the key pieces from all four to help guide clients in the drug and

device industries as they continue to navigate the new media landscape.

User-Generated =

Outside of Company Control

First,

Do Not Mislead

Responding to Unsolicited Requests for

Off-Label Information (Dec. 2011)

Fulfilling Regulatory Requirements for

Postmarketing Submission of Interactive

Promotional Media (Jan. 2014)

Correcting Independent Third-Party

Misinformation About Prescription Drugs and

Medical Devices (June 2014)

Internet/Social Media Platforms with

Character Space Limitations (June 2014)

When the Food and Drug Administration (FDA or the Agency) held a public hearing on the use of the

internet and social media to promote regulated products, many in the industry were hopeful we

would soon have clear direction on how to evolve our communications for the digital age. Nearly five

years later, we’re still waiting for that guidance to be complete. Just recently, FDA released two draft

guidance documents, the latest in a series on various elements of digital engagement bringing the

total to four out of an expected five. Here’s what we’ve got so far:

FDA uses the term “non-misleading” 20 times in these four draft guidance documents. “Accurate” comes up 22 times. Clearly, this is a guiding principle for the Agency, and you’ll notice each one of the below points is constructed with it as its ultimate goal.

While much is spelled out specifically in these documents, there is a lot that remains up for interpretation. When in doubt, a good place to start is by asking: Could this be considered misleading? If the answer is anything but "No," don’t do it.

One of the most important things the Agency does in its guidance thus far is to clarify what content companies are responsible for and, perhaps more importantly, what they are not responsible for. This is one of the biggest issues keeping most drug and device makers on the sidelines of social media engagement. FDA has, in three of its four draft guidance documents, made some important statements about company responsibility:

Company is not responsible for UGC that it does not control or influence

Company is responsible for content created by employees, agencies, and contractors acting on behalf of the company (including paid influencers and spokespeople)

Company is not responsible to monitor and correct information online about its products

If a company decides to correct information online about its products, it is not responsible for correcting all content on that site, just the clearly defined section it is correcting

Once a company corrects information online about its products, it is not responsible for monitoring the site for further comments or updates

One important thing to keep in mind regarding company responsibility and UGC that isn’t mentioned in the draft guidance is the reporting of adverse events. While a company may not be held responsible for the content of the post, any time a company employee or contractor comes across an adverse event report online, it must be reported to FDA in accordance with company policies. This is the other big issue keeping the industry from more active engagement online and one that isn’t going to change.

There are Some Exceptions

to the Standard Procedures

FDA’s regulation of social media stems from its authority over product labeling and advertising. Therefore, barring exceptions, the current rules for those communications, such as balancing risk and benefit, apply in social media channels as well.

The FDA social media draft guidance contains a few such exceptions, including:

Correcting Misinformation: The Agency recognizes that user-generated content (UGC) often includes incorrect information about regulated products. It also knows that the manufacturers of those products have the most incentive to correct that information. In the interest of encouraging non-misleading communications, the Agency stated in its recent guidance that companies don’t need to adhere to traditional guidelines when correcting such misinformation.

Responding to Unsolicited Requests for Off-label Information: Just as manufacturers have greater incentive to correct misinformation about their products, FDA recognizes that they also know more about experimental uses of those products than anyone else. In the event that someone asks about an unapproved use of its product, the Agency has said it will not object to a company providing that information (traditionally a no-no). Requirements include the information being non-misleading, narrowly tailored to the question asked, private between the company and individual, and from the medical department and not marketing or sales.

-

No Shortcuts for

Short Form

While this one wasn’t a surprise, there were some in the industry still holding out hope for product-promotional tweets. Some rules just don’t have exceptions.

In its latest round of draft guidance, the Agency explicitly addressed the use of character-limited platforms (Twitter and paid search) for promoting regulated products. In opening the door for product promotional tweets by outlining the requirements and giving an example, FDA social media guidance has left little room for saying anything beyond the name, indication, important risk information, and a link to the full important safety information (ISI). Even in the Agency’s example with a fictional drug with a short name and straightforward indication and risks, there were only 6 characters

remaining for any kind of promotional messaging. While it would have been nice to see some kind of innovative solution to communicating fair balance in short-form, it isn’t surprising not to see one.

While there are certainly other insights that can be applied from the Agency’s draft social media guidance, these are the ones most likely to have an impact on future social media engagement by the industry. We’re likely to see some additions to this list following the release of the final social media guidance document on the use of links. Whether it beats the July 9 deadline or not, just don’t bet on any major surprises and rest assured you’ll see “non-misleading” a time or ten.

For more information, please contact:

Josh Baldwin 646-500 7830 josh.baldwin@mslgroup.com