Two years ago when I started my business eight out of ten people I met with told me “Social media is a fad. I'm not willing to risk spending money in a down economy on something that won't be in existence in another year or two.” Two years later, Facebook announced it has one billion active users and I never hear the phrase “Social media is a fad.” Social media is big business. Social media is being woven into businesses of all sizes. Social media is where people go before they purchase your product or service. And businesses are starting to realize they must develop a presence on social networks if they want to survive.
For some, all this social media participation raises regulatory concerns. when regulated companies participate in social media their activities are monitored, saved and archived. I've written about some concerns of attorneys and financial services providers. Today I'd like to look at issues facing pharmaceutical, biologic and medical device companies regulated by the FDA.
The FDA certainly recognizes the need for guidance, yet it has provided a limited amount of guidance. It describes social media guidance as among its “highest priorities,” even listing topics in development:
- Responding to unsolicited requests
- Fulfilling regulatory requirements when using tools associated with space limitations
- Fulfilling post-marketing submission requirements
- On-line communications for which manufacturers, packers, or distributors are accountable
- Use of links on the Internet
- Correcting misinformation
As you might expect, the FDA has held a public hearing on social media and is conducting surveys on its impact. But, it has only issued one draft guidance, “Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices.” And that guidance barely mentions social media.
Good news. Guidance is on the horizon. It is a big horizon, but, nonetheless, it's coming. Regardless of the outcome of the upcoming Presidential election, I believe the Congress will consider the FDA Safety and Innovation Act. This Act will require the FDA to issues guidance (hopefully within two years) “regarding the promotion, using the Internet (including social media), of medical products.”
Off-Label Information
Until then, here's what I know. The FDA’s draft off-label guidance focuses on whether a company solicited another party’s request for off-label information and, if not, how the company may respond. It discusses a company's proper response. And it discusses a new distinction between public and private responses.
The FDA has also provided examples of what it indicates may constitute solicitation by a company through social media:
- Tweeting study results and suggesting that an off-label use is safe and effective.
- Establishing standard response websites that in part include off-label information.
- Encouraging third-party bloggers to post about off-label use.
- Creating a username, e-mail address, or URL that suggests off-label use.
- Requesting users to post videos about their product experience on a site such as YouTube, resulting in videos on off-label use.
It appears from these examples that the FDA will hold companies responsible not only for their own actions, but for the actions of third parties i.e. bloggers, if the company solicited the blogger to post incorrect or inaccurate information. And, the FDA will continue to monitor company representations. I'm sometimes accused of being cynical, but I also think the FDA has indicated it will hold companies responsible for the content of third-party postings even if the company did not request that content.
In its example of a company inviting users to post videos of their product experience, the FDA cites a company that did not request off-label videos. Yet it considered users posting such videos to have been solicited by the company. This leaves things a bit blurry. My suggestion: companies hosting social media sites should limit the subject matter of user posts, disclose those limits, and screen for improper user posts. Companies must keep a tight rein on their social sites.
Disclosure Requirements
Social sites generally do not provide site owners enough space for the type of risk disclosures required by the FDA. In a recent untitled letter, the FDA found the following sponsored link (names redacted) misleading because it suggested efficacy without disclosing risk information:
- [Drug] Lowers Risks of Future Heart Attack or Stroke from [disease]
- See how [Drug] may help patients with recent heart attack, recent stroke, or established [disease] at Diseasefacts.com
The FDA also found the following sponsored link misleading, even though it makes no explicit claim about the drug:
- [Drug]® Official Site
- www.DRUG.com [Disease] Can Be Tough. Learn About a [Disease] Medicine
This example illustrates that, even if the sponsored link or widget does not explicitly state that the product treats the disease, the FDA may find an implied connection and require risk disclosures in the link text.
My suggestion: avoid such advertisements altogether until the FDA offers clearer guidance.
Click To The Disclosure
In the examples above, the links took you to another page containing disclosures. The FDA found placing such disclosures “one click away” from the product claims to be deficient: For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.
Because this makes no sense at all, this might change. But it might not.
Employee-Created Content
The FDA issued an untitled letter to a company whose sales representative allegedly created and uploaded to YouTube a video that promoted a product but contained no risk disclosures, fails to disclose the drug's indication and contains material misleading facts. Could this have been avoided by the company having social media policies in place and training their employees to use social networking properly?
Third-Party-Created Content
The FDA is holding companies responsible for the creation and posting of certain third-party content. This poses a variety of challenges for these companies. Some feel the challenges are so great they are not going to participate on social sites at all, but this doesn't stop people from talking. It just limits the company's ability to listen and respond. Other companies are implementing restrictions on their social media sites. Some screen for and remove improper Facebook comments. Those doing this often outsource the responsibility to companies specializing in this type of work.
Conclusion
There remain many unknowns that we hope the FDA and Congress will address quickly and clearly. In the meantime, companies need to have a social presence and they need to do it carefully, thoughtfully and properly. Companies must implement a well thought out strategy that should be in writing and disseminated to its employees. Companies should also have internal social media policies and train their employees to use and understand these policies and the company's overall social strategy. Wisely taking advantage of social media may determine the success of a company and/or a drug it is promoting.
