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September 12th, 2014
Correcting Third-Party Misinformation Online
In June 2014, the FDA issued draft guidance for the pharmaceutical industry titled "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices." The draft guidance describes FDA's current thinking about how pharmaceutical companies should respond, if they choose to respond, to misinformation posted by independent third parties about the companies' products on the Internet or through social media. In short, if a company voluntarily corrects misinformation in a truthful and non-misleading manner, and as described in the draft guidance, the FDA will not object - even if the correction does not otherwise satisfy applicable regulatory requirements for pharmaceutical labeling or advertising, such as obtaining prior approval for the statements from the FDA or including required risk information.
While the guidance, when finalized, would affect only pharmaceutical companies, we believe it has interesting things to say to non-pharmaceutical companies active in social media as well. It also speaks to regulators and self-regulators working in non-pharmaceutical areas. Here are some highlights:
If you touch it, you own it. But not necessarily forever.
In effectively creating a safe harbor under the draft guidance for companies that voluntarily correct third party misinformation, the FDA started its analysis by determining that the guidance would not apply when the company is itself responsible for the misinformation. As a general matter, the FDA determined that companies are "responsible for communications that are owned, controlled, created, or influenced, or affirmatively adopted or endorsed by, or on behalf of, the [companies]." The guidance then sets out four examples, two where the company is itself responsible for the misinformation and two where it is not. The examples where the company is considered responsible include, not surprisingly, (i) a scenario where a member of the company's own marketing department posts incorrect comparative product information on a third party message board; and (ii) the company hosts a discussion group on its website, removes or edits negative statements about its products, and adds positive ones.
Examples where the company is not considered responsible for third party content include: (i) the company becomes aware of a blogger, with whom it has no relationship, who is posting incorrect information about the company's products; and (ii) the company hosts a discussion forum about its products on its own website, which the company monitors for profanity and obscenity but in which it does not otherwise participate, and which includes a conspicuous disclosure that the company is not the creator of the content. In both of these scenarios, under the guidance, the company may, but is not required to, address the incorrect information posted by the independent third parties. Moreover, the guidance provides that even if the company does take steps to correct the inaccurate information in these circumstances, the company is not obligated to continue to monitor the site where it had discovered and corrected the erroneous information about its products.
Thus, consistent with the Communications Decency Act, cited by the FDA in its guidance, a company's knowledge of, or even its hosting of, inaccurate information posted by third parties about its products is, in and of itself, insufficient to make the company responsible for it.
If you correct the bad, you have to correct the good too.
The draft guidance says that covered companies are not required to correct misinformation posted by independent third parties. However, if covered companies do choose to correct misinformation, they should not do so selectively - correcting misinformation that portrays their products in a bad light, while leaving untouched any exaggerated and unsubstantiated claims touting the benefits of its products.
This issue comes up frequently for both pharmaceutical and non-pharmaceutical companies. While marketers are eager to set the record straight when user-generated content unfairly denigrates their products, some may be less inclined to correct posts that attribute benefits to the products that the company itself could not substantiate. The FDA's guidance represents a common sense approach for pharmaceutical and non-pharmaceutical companies alike. User-generated content is the good, the bad and the ugly. While companies can freely remove the ugly (profanity and obscenity), they should not delete the bad (the inaccurate and critical) if they want to retain the good (the inaccurate and too positive) on the sites they control. Marketers should leave up both the good and bad from users (and state clearly that they're doing just that) or remove them both.
Comments on the draft guidance are due to FDA by September 16th and may be submitted via http://www.regulations.gov.
Law, regulations and best practices for companies engaged in social media marketing continue to evolve. The FDA's guidance should help both pharmaceutical and non-pharmaceutical advertisers set policies for themselves about how to engage with user generated content. If you have any questions about the FDA draft guidance, or about other advertising and marketing law issues, please contact Terri Seligman at (212) 826 5580 or firstname.lastname@example.org, or any other member of the Frankfurt Kurnit Advertising Group.
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