FDA draft guidance on addressing misinformation clears White House review

Life Sciences | By AMANDA CONTI

Jun. 26, 2024

A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products. This administrative review is last procedural step before the FDA can publish the document.

Quick regulatory background: The FDA’s role in ensuring accurate information about regulated products

  • The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information. In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4 for medical devices as “the objective intent of the persons legally responsible for the labeling of” drugs of devices. In practice, the intended use of a product is the sponsor’s idea of how it will be used as outlined in approved labeling claims, marketing and advertising, and distribution of a product.
  • A sponsor’s claims about the intended use of their product must align with the indications that the FDA has approved, cleared, granted, or otherwise authorized. Intended use includes such things as the condition or disease which the product is meant to treat, the population for whom it is intended, and the route, frequency of administration, and duration of use for the product.
  • In addition to required labeling, the FDA also regulates certain advertising and promotional information made about the medical products by their sponsors. For drug products, the FDA regulates both product labeling (21 CFR 201) and promotional labeling (21 CFR 202). The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) and includes prescribing information (PI). Separately, “promotional labeling” includes any type of promotional material – including advertisements, informational brochures or other disseminated copy from the drug’s manufacturer, packer or distributor. Promotional labeling information must be submitted to the FDA’s Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB) “at the time of initial dissemination” using Form 2253, “Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use.” Notably, the FDA’s authority over advertising for medical devices is focused on “restricted” medical devices (i.e., those sold under authorization from a licensed provider or other regulatory-specific situations) and is submitted as part of the medical device’s listing (general controls), and the agency may request a copy of all advertising materials for good cause (See a Congressional Research Service explainer on this topic here).

However, not all information available to the public about a product is regulated by the FDA.

  • As the FDA explained in a 2014 draft guidance document on correcting information from external sources, “the Internet and Internet-based technologies have made it easier for third parties who are independent of firms [i.e., sponsors, developers and manufacturers] to disseminate information about drugs and devices.” This information, which the agency called “user-generated content” (UGC) in that document, “might not always be accurate and may be dangerous or harmful to the public health.”
  • The guidance went on to define “misinformation” as “Positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular.”
  • The draft document offered some preliminary recommendations on how drug and device firms could “correct” misinformation. The document flagged FDA’s concerns about misinformation online, and “determined it may benefit the public health for firms to correct misinformation about their products.” Under the policy outlined in the draft guidance, firms would be able to “voluntarily correct” misinformation “in a truthful and non-misleading manner” without falling afoul of the labeling or advertising regulations cited above.
  • Per the guidance, the agency stated it wouldn’t consider certain methods (as described in that draft guidance) of correcting misinformation to be labeling or promotion: “FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any. If a firm chooses to respond to misinformation about its products using non-truthful or misleading information or in a manner other than that recommended in this draft guidance, however, FDA may object if the information provided by the firm does not comply with applicable regulatory requirements related to labeling or advertising, if any.” In general, the FDA stated that firms typically wouldn’t need to submit their “voluntary corrections” to the agency for review, but recommended they be kept in firm records.
  • While industry concurred that online platforms could increase misinformation, they cited some concerns with the FDA’s outlined approach. In particular, regulated industry stakeholders flagged some confusion about what would be expected of developers. Medical device trade association AdvaMed noted that “the Internet universe is immense and no one entity can be expected to monitor the entire Internet,” highlighting industry’s limited ability to take on misinformation broadly. Further, both AdvaMed and trade association PhRMA mentioned complexities with misinformation that is “influenced” (in the FDA’s terms) by the firm’s available information, asking for clarity on the term – and with PhRMA raising concerns that companies could be held responsible for misinformation that is out of their control. PhRMA went on to specifically question the regulatory categorization of these communications, noting that FDA “appears to recognize that some statements on social media correcting misinformation are neither “labeling” nor “advertising,” but fails to give guidance as to what kinds of statements would be regulated as such.”
  • In effect: While the FDA said it would not be taking regulatory action against good faith, voluntary efforts to “correct” misinformation, industry requested significantly more clarity about the applicability of FDA’s regulations, their responsibility in this area, and the scope of FDA’s authority and their requested activities.
  • Notably, FDA never finalized its 2014 draft guidance, which remains in draft format.

Combating misinformation has been a top priority for FDA leadership

  • Combatting misinformation is a top priority for FDA Commissioner ROBERT CALIFF, which he has referred to as a “leading cause of preventable death in America.” Notably, concerns about the societal and health impacts of misinformation have increased in recent years, with contributions from technology (artificial intelligence), communication (social media) and public health (the Covid-19 pandemic). For example, recent guidance from the National Institute of Standards and Technology (NIST) offered insights into how Generative AI could contribute to health care misinformation.
  • What is the FDA thinking about? An October 2023 report from the Reagan-Udall Foundation, undertaken at Califf’s request, re-asserted the concerns flagged in 2014 draft guidance document, including “the spread of false information [that has] accelerated in recent years, in part because more people than ever before are accessing information on the internet and via social media.” It also acknowledged industry’s concerns, and in particular that “efforts to “address” mis- and disinformation can, themselves, be misunderstood” and that reactive strategies (e.g., trying to correct misinformation as it comes) “is a terrible waste of time” (per public health experts). In the report, researchers recommended that FDA develop more resources internally for combatting misinformation – such as improving the process by which FDA responds to media inquiries and conducting message testing to identify better methods.
  • The Reagan-Udall Foundation report also contained recommendations for how the FDA should work with industry to combat misinformation. Specifically, researchers recommended that the agency “Engage with companies that produce or sell FDA-regulated products to coordinate, when appropriate, a clear and consistent system for product- or commodity-specific announcements,” and further to “conduct a review to determine whether FDA regulation may unnecessarily limit an industry or organization’s ability to respond to health misconceptions and effectively improve public understanding of relevant information.” Notably, these are only two recommendations out of over 40 in the report, the significant majority of which are focused on the improvements that the FDA itself can make as an organization.

Ten years later, we’re imminently expecting a new guidance on misinformation

  • In May 2024, AgencyIQ flagged that a new guidance on misinformation was submitted by FDA for administrative review. The new draft guidance document is entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” and the document was received by the White House’s Office of Information and Regulatory Affairs (OIRA) on May 21, 2024. OIRA is the White House’s regulatory review body, charged with reviewing certain policies before they are released to the public to help ensure a consistent federal approach.
  • What’s in the guidance? As AgencyIQ previously discussed, the content remains unclear; the guidance was not included in any of the agency’s 2024 guidance agendas. Still, AgencyIQ believes – based on Califf’s remarks and the Reagan-Udall Foundation’s report – that it likely will provide an update to the concepts offered in the 2014 draft guidance on “Correcting Independent Third Party Misinformation.” The new document may also provide more information about what activities sponsors may take to track and respond to misinformation, and the regulatory framework under which they may “address” these issues without falling afoul of the labeling or advertising regulations.
  • Now, the document has been cleared by the White House’s OIRA. The action was “Consistent with Change,” meaning that OIRA did request some minor updates. The conclusion means that the FDA can issue the guidance at its discretion – although there’s no required timeline for release.
  • What’s next? Following OIRA clearance, FDA typically publishes guidances within a few days to a few weeks. That said, looking at the most recent example, the agency’s long-awaited guidance document, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, was published just one day following its OIRA clearance [ Read AgencyIQ’s analysis of that document here]. While this could be due to its tardiness on a legislative deadline, the speed could also indicate that the agency is working to publish ahead of the July 4 holiday next week.

Featuring previous research by Laura DiAngelo.
To contact the author of this item, please email Amanda Conti ( aconti@agencyiq.com).
To contact the editor of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com)

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