June 20, 2014

FDA Provides Internet Guidance (Part 1 of 2): Correcting Internet Misinformation

Seller Beware: Consumer Protection Insights for Industry

Earlier this week, the Food and Drug Administration (FDA) released two draft guidance documents for industry that offer "recommendations" regarding how pharmaceutical and medical device manufacturers can use Internet and social media platforms to (1) correct independent third party misinformation about prescription drugs and medical devices; and (2) present risk and benefit information where there are character space limitations (e.g., Twitter). This blog post will address the former and we will have a separate post on the latter.

FDA's first draft guidance, entitled "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," permits companies voluntarily to correct third-party misinformation related to their own products and provides recommendations about how to provide such corrections. The guidance defines "misinformation" as user-generated content (UGC) that gives

"positive or negative incorrect representations or implications about a manufacturer's product [and is] created or disseminated by independent third parties who are not under the manufacturer's control or influence and that is not produced by, or on behalf of, or prompted by the manufacturer in any particular."

The guidance does not apply when the manufacturer creates the initial product communication that contains misinformation.

FDA recommends that manufacturers making corrections address all misinformation in a clearly defined portion of a forum on the Internet or social media platform, whether the misinformation is positive or negative. FDA may object if a manufacturer responds to misinformation about its products using false or misleading information or in a manner other than that recommended in the draft guidance, or the manufacturer does not otherwise comply with applicable promotional labeling regulations. Generally, FDA recommends that corrective information be:

  1. relevant, accurate, responsive, limited and tailored to the misinformation;
  2. be non-promotional in nature, tone and presentation;
  3. be supported by sufficient evidence; and
  4. disclose that the person providing the correction is affiliated with the manufacturer.

FDA recommends that the corrective communication include the FDA-required labeling or a hyperlink to such information and that the corrective information be posted in conjunction with the misinformation (e.g., same area or forum).

While helpful in calibrating company practices, ultimately, the new draft guidance does not break significant new ground, and largely adheres to FDA's past thinking on these issues. Although the guidance documents are non-binding, FDA may now decide to step up enforcement, so companies must carefully consider their internal policies and employee handbooks in light of the Agency's positioning on these issues.

© Arnold & Porter Kaye Scholer LLP 2014 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

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