Big Pharma and Social Media: How to Avoid Trouble with the FDA
Pharmaceutical companies can use social media to engage and educate patients as well as to provide reliable information about their products. But how do companies tap social media without running afoul of the Food and Drug Administration (FDA) and various regulatory requirements? To find out, I asked Colleen Tracy James, a partner in Mayer Brown’s New York office, where she is a member of the firm’s intellectual property practice and life sciences group.
Belbey: What are the challenges facing pharmaceutical firms when using social media?
James: The internet is the wild wild West. We are still figuring out how to maneuver and make sure information is reliable and trustworthy. This is especially important when it comes to pharmaceutical products because it impacts our health and well-being. Pharmaceutical companies face a lot of challenges on social media, such as how to handle incomplete and misinformation about their products. We all remember the famous Kim Kardashian Instagram post where she touted the benefit of a drug that treats morning sickness, but she did not disclose any of the side effects. According to the FDA Guidance, when you use social media, you need to include the ‘good, bad and the ugly' about your product. Your social media posts need to be fair and balanced.
Belbey: How can pharmaceutical companies control the message and the information?
James: One way to control the message is to create what the industry calls a “controlled environment” such as creating a company webpage for a drug or disease. In this way, firms can make sure information is accurate and complete. That keeps them in line with the FDA regulations. That’s very different from third party information, where the company does not have control over how its product are discussed.
Belbey: Can firms use controlled environments and social media to correct misinformation?
James: Yes. If patients are talking to each other and sharing a misconception of your product, you may want to, as a company, respond to that. You may decide to allow certain employees in the corporation to engage with potential consumers on social media and to answer questions. Or you could provide a chat room as part of your own platform. In that case, your obligation to correct misinformation may be heightened because now you have control of that website.
Belbey: How can pharmaceutical firms use Twitter?
James: Twitter is one of the areas where we’ve seen some specific guidance from the FDA. Due to its character limitations, the FDA is concerned that if you don’t have enough space, you can’t provide a fair and balanced (benefits and downsides) view of your drug. Pharmaceutical companies face serious penalties by the FDA if they don’t make the proper disclosures -- something that pharmaceutical companies want to avoid. If you are responsible for disseminating misinformation about your drug, and the wrong person takes it because he or she wasn’t aware of the contraindications or the side effects, the pharmaceutical companies open themselves up for liability. In short, pharmaceutical companies must be careful not to mislead consumers on Twitter.
Belbey: Given that there are real risks associated with not complying with advertising rules and regulations, how should firms move forward safely?
James: Pharmaceutical firms should develop clear and decisive social media advertising policies. First, they need to figure out which platforms they will use, how they will control their messages, whether they’re going to allow chat rooms, and how to manage comments from patients who want a dialog. If interactivity is permitted, companies need to clearly define which employees may interact with consumers, patients and doctors on social media.
The firm also needs a content strategy, so that responses are in compliance with what the FDA has approved the pharmaceutical company may say about their product. You also may need a team of legal advisers to confirm that content about your product is okay to put on social media. Pharmaceutical companies must be careful that employees don’t provide people with wrong information when responding on social media. For example, you can’t say, “This medication is for a headache but you can also take it for something else that’s not a headache.” That would be a violation, historically speaking, as firms are not allowed to market their drugs’ off-label uses or mention off-label uses. And finally, I also suggest that companies have a compliance officer tasked with making sure there’s a policy in place and it’s being complied with and updated with evolving FDA guidance.
Since the FDA was created, we’ve gone from radio to TV and to now social media. Just like the past when industry adapted to new forms of communications, pharmaceutical companies are now figuring out how to advertise and communicate using the latest media within the regulatory framework.
Contributor’s notes: For more information, read “5 Social Media Pitfalls In The Pharmaceutical Industry” by Henniger Bullock and Colleen Tracy James, Mayer Brown LLP. https://www.mayerbrown.com/files/News/29b609ec-4b5a-4ce3-950c-04026ef73f85/Presentation/NewsAttachment/39dca070-2b87-49a6-b03a-04e8e6f9bafc/5SocialMediaPitfallsInThePharmaceuticalIndustry.pdf
Here is guidance from the FDA pertaining to advertising and social media for your convenience:
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Draft Jan 2017): https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537130.pdf
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers (Draft 2017): https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537347.pdf
FDA Draft Guidance for Industry Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401079.pdf
FDA Draft Guidance for Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (June 2014): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401079.pdf
Fulfilling Regulatory Requirements for Postmarking Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Draft Jan 2014): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm381352.pdf
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (December 2011): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf
This blog appeared previously on Forbes.