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FDA Weighs in Regarding Online Medical Misinformation

Online Health Conversation Poised for a Big Leap Forward

In a potentially far-reaching policy announcement, the FDA recently released draft guidance concerning how device manufacturers and pharmaceutical companies should address third-party misinformation regarding their products. For many in-house legal teams, this guidance no doubt provides some sense of clarity (if not relief) regarding the scope of responsibility (and liability) that companies have for online misinformation.
Specifically, “this draft Guidance applies when a company is not responsible for a product-related communication that appears on the company’s own forum, an independent third-party website, or through social media, and the company chooses to correct misinformation about its own product contained in that communication.”

The FDA is particularly interested in addressing issues surrounding so-called “third-party sites” that are out of the immediate control of a company’s marketing and communications team, including user-generated content that appears on websites and forums as well as blogs, microblogs, social networks, online communities, and live podcasts.

It’s important to note that when a company “writes, collaborates on, or exerts control or influence on product-specific content provided by a third party, to the extent that responsibility for the development of the content is imputable to the firm, the recommendations set forth in this guidance do not apply.”

There are five key policy areas that the FDA addressed:

1.    When is UGC (user-generated content) classified as “misinformation”?

a)    “Misinformation” is defined as positive or negative incorrect representations or implications about a company’s product created or disseminated by independent third parties who are not under the company’s control or influence and that is not produced by, or on behalf of, or prompted by the company in any particular instance.
b)    If a company voluntarily corrects misinformation in a truthful and nonmisleading manner and as described in the draft guidance, the FDA does not intend to object if the corrective information voluntarily provided by the company does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.

2.    Definition of corrective action

a)    Relevant and responsive to the misinformation
b)    Limited and tailored to the misinformation
c)    Nonpromotional in nature, tone, and presentation
d)    Accurate
e)    Consistent with, and including ready access to, FDA labeling (via link or PDF)
NOTE: The link may not lead to a promotional website, even if the labeling is published/housed on that website.
f)    Supported by sufficient and substantial evidence
g)    Posted in conjunction with the misinformation
h)    Disclosed that the person correcting the misinformation is affiliated with the company

3.    What if there is an entire forum that contains multiple instances of misinformation?

a)    The company is not expected to correct every instance of misinformation in a given site/forum. The company should, however, correct consecutive instances of the misinformation, note which instances it is correcting, and provide the date of the correction.

4.    Approaches for correcting misinformation

a)    Post corrections directly to the forum
b)    Request that the author correct the misinformation, or
c)    Request the administrator to allow comments to be made to the content

5.    Additional ongoing requirements for the company

a)    Companies cannot be held responsible if the author refuses to make the corrections, or fails to include the appropriate links to FDA labeling, as long as the company provides complete corrective information.
b)    Companies are not required to continue to monitor the forums to ensure corrections are made or to ensure that additional misinformation is not posted.
c)    Companies are not required to submit corrections to the Agency, but are encouraged to keep documentation in case the Agency has questions.

Conclusion
This draft guidance addresses many key aspects surrounding pharma and device participation in the online social conversation, specifically, when and how companies can address misinformation. It also clarifies the range of responsibility that companies hold. The net result of this guidance promises to be very positive for both industry and patients, allowing for misinformation to be addressed in a timely and reasonable fashion, without the fear of FDA warnings (assuming that the comments fall in line with the directives outlined above).

This post is provided by Cadient for information purposes only and is not intended and should not be construed as regulatory or legal advice.

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Gabrielle Pastore

Gabrielle Pastore

Vice President, Global Strategic Commercial Innovation at Cadient Group
As VP of Commercial Innovation, Gabrielle leads Cadient's efforts to help life science companies optimize the performance of their brands and marketing operations. Leveraging digital technology and other tools for fostering innovation, she and her team will create business strategies that deliver results-oriented planning, best-in-class customer insights, and productive new approaches to global marketing and brand commercialization. Gabrielle joined Cadient from AstraZeneca, where she built a 18-year management career spanning a broad range of responsibilities. Most recently, she served as global director of commercial innovation, leading enterprise-wide digital marketing initiatives in Japan. Prior to that, she was brand director for managed markets in the U.S., guiding major brands through key life cycle events and creating a large cross-functional team to address issues such as access and reimbursement. From 2005 to 2010, Gabrielle acquired substantial global innovation experience, working as global brand manager for AstraZeneca UK, then as marketing director for AstraZeneca Japan. She began her pharmaceutical career in product management, working also as a district sales manager before moving into brand management. Gabrielle holds both a Bachelor of Science in Agricultural Business Management and a Bachelor of Science in Animal Science from North Carolina State University.

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