New FDA Guidance Exempts Manufacturers From Correcting Online Third-Party Claims

The FDA, in new draft guidance, says industry has no obligation to correct misleading statements or claims made about their products by third-parties on social media, on websites, and through online forums.

“We recommend that any corrections should address all misinformation in a clearly defined portion of a forum on the Internet or social media, whether the misinformation is positive or negative,” Thomas Abrams, director of FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research, said in a blog post.

The agency acknowledges that the Internet has made it considerably easier for outside third parties — from other companies to consumers — to distribute information about products, including factually incorrect or misleading information, the Regulatory Affairs Professionals Society (RAPS) said Tuesday.

The fear from industry was that by responding to misleading claims with anything other than full and complete prescribing information, device makers could be cited for misleading promotion. And in many forums, companies are restricted in the amount space they have to respond to someone, RAPS added.

The draft gudiance, which was released alongside another guidance on how to use space-constraining platforms, only applies to content created or disseminated by independent third parties, including bloggers, forum commenters, and social media users.

The Wall Street Journal notes that for third-party websites, such as Wikipedia, the draft guidance indicates that industry can correct misinformation, but that any correction must include balanced information and the source of the revision or update must be noted.

The FDA says, for example, a company may provide a link that goes directly to the FDA-required labeling, or may provide a link that opens a new window to a PDF. The guidance adds that information should not be provided through a link to a promotional website, even if the required information is available on the promotional website.

Some suggestions the agency provides when correcting information include:

• Be relevant and responsive to the misinformation.
• Be limited and tailored to the misinformation.
• Be non-promotional in nature, tone, and presentation.
• Be accurate.

The guidance notes it is not applicable when a company is responsible for the product communication that contains the misinformation. A device maker is responsible for communications owned, controlled, created, or influenced by or on behalf of the company. Industry has 90 days to comment on both drafts.