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FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation

Posted 17 June 2014 | By Alexander Gaffney, RAC

FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation

The US Food and Drug Administration (FDA) has released a new draft guidance document on social media focused on how companies can correct blatant misinformation contained on the Internet and social media channels, long a source of frustration for FDA-regulated companies.


The issuance of guidance on social media was required by the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 1121 of which calls for FDA to, by August 2014, "issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA]."

For members of industry, the allure is relatively straightforward. As social media networks like Facebook, Twitter and Instagram have proliferated and become popular, opportunities exist to reach out to those users and members of specific communities to market a drug or answer questions.

However, the varied capabilities of the platforms represent myriad problems. For example, it is difficult to contain all the information about a product in a single 140-character tweet. FDA has sanctioned a company in the past for "liking" an unapproved claim on its Facebook wall. And even hidden metadata can be grounds for FDA finding a claim to be misbranded.

With so many questions left unanswered on how to appropriately use the platforms, industry has clamored for guidance from the agency-guidance that now appears to be forthcoming.

But while industry long believed that FDA's thinking on social media would be contained within a single guidance document, FDA quietly announced in January 2014 that it would instead by launching several guidance documents on social media topics, including character space limitations, the appropriate use of links, and sponsor corrections of misinformation.

FDA has already released two of those guidance documents: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics and Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, which was also released today.

Misinformation Guidance

The agency is now out with its third social media draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

As FDA explains in the guidance, the Internet has made is considerably easier for outside third parties—from other companies to consumers—to disseminate information about drugs, including factually incorrect or misleading information.

And that information sometimes finds its way onto websites where the sponsor of a drug product has the opportunity to correct misinformation about the product. The question companies have had until now is, ”How can we do so without falling afoul of FDA regulations on product promotion?”

The fear of some companies was that by responding with anything other than full and complete prescribing information, the companies might be cited for misleading promotion. And in many forums, companies are constrained in the space they have to respond to someone.

The good news for companies: FDA says it "does not intend to object" if a company "voluntarily corrects misinformation [posted by a third party unaffiliated with the company] in a truthful and non-misleading manner"—a manner described in FDA's latest draft guidance.

How to Correct

FDA's guidance contains a few pointers for companies wishing to correct misinformation:

  • Be relevant and responsive to the misinformation.
  • Be limited and tailored to the misinformation.
  • Be non-promotional in nature, tone, and presentation.
  • Be accurate.
  • Be consistent with the FDA-required labeling for the product.
  • Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs.
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author).
  • Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

For example, even if a product has multiple approved indications, companies should limit their corrective information to the particular indication discussed by a user incorrectly, FDA said.

No Obligations to Correct

FDA notes that even if a company is made aware of misinformation, it is under no obligation to correct that information. However, on forums controlled by a company where users can post, FDA says the company should include an "overarching clear and conspicuous statement that the firm did not create or control the user generated content."

The warning is in some ways reminiscent of a February 2013 Warning Letter sent by FDA to a company after a user posted misleading information on the company's Facebook page, which the company then "Liked" under its account. FDA's implication was that the "Like" was indicative of a company's endorsement—an indication that even non-verbal endorsements of information can get companies in trouble.

FDA also notes that even if a company corrects one piece of information on a website, it is under no obligation to correct all misinformation on a site, especially if there are many instances of that misinformation on the site. However, "A firm should correct all misinformation in the clearly defined portion of the forum it identifies," FDA added. Companies cannot, for example, choose to comment on a posting that contains both factually incorrect benefit and risk claims and correct only the risk claims. Neither can it address only postings on a site that overstate risks while ignoring postings that overstate a product's benefits.

Corrections to information may either be posted on the website directly (if possible) or, alternatively, sent to the author of the online posting for potential clarifications to the piece, similar to how a company might respond to a journalist or news website.

Wikipedia … Kind of

FDA's guidance also makes note of how to correct information on Wikipedia, or as it is referred to in the guidance, an "Internet-based, interactive, collaboratively edited encyclopedia." FDA said it suggested contacting the author of the webpage and providing corrective information to the author. It did not mention if directly editing the webpage would be appropriate.

Companies are also not obligated to continue monitoring a page after they have submitted information to correct misinformation, FDA said, though the company may choose to do so. Extensive replies to the same posting may require the company to comply with applicable regulatory requirements, however. (See Example 14 in the guidance).

Notably, FDA said it does not expect companies to submit corrections (i.e. to correct misinformation) to the agency, though it "recommends that firms keep records to assist in responding to questions that may come from the agency." Those records should include the misinformation, the site URL, the date, and the corrective information submitted.

Comments on the draft guidance are due in 90 days.


Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (FR)


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