Overview
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.”
The guidance finalizes FDA’s revised draft guidance issued in October 2023 concerning firm-initiated communications of scientific information on unapproved uses (SIUU) of approved or cleared medical products to healthcare providers (HCPs) who prescribe for, or administer medical products to, patients. Broadly, the final guidance steps back from FDA’s position in the draft guidance that appeared to afford FDA greater discretion for determining communications to be inappropriate. This increased discretion would have heightened regulatory risk, and industry stakeholders widely criticized the stance. The comparatively modest approach of the final guidance emphasizes that any communication regarding unapproved uses must be truthful, comprehensive, and focused on the scientific content rather than promotional tactics, which do not align with the intent of informing clinical practice.
In Depth
BACKGROUND
The Federal Food, Drug, and Cosmetic Act and the Public Health Service Act prohibit the introduction of medical products into interstate commerce if they do not comply with premarket requirements or are misbranded or adulterated. This prohibition includes distributing medical products for unapproved uses, even if the product is approved for other purposes. HCPs often seek SIUU to enhance their clinical practice. However, a firm’s communication about SIUU can indicate improper intent, potentially violating federal law.
The FDA’s final guidance defines “firms” as entities responsible for labeling medical products, including manufacturers, distributors, and their representatives. The guidance outlines the characteristics of source publications in firm-initiated communications that fall within the enforcement policy and provides recommendations for sharing published scientific articles, clinical practice guidelines, reference texts, and digital clinical practice resources. Firm-generated presentations of SIUU, when provided with a source publication, are subject to different considerations than those consisting solely of source publications and recommended disclosures. These source publications should come from independent publishers with editorial input to ensure they are not influenced by the firm’s business interests.
UPDATES TO GUIDANCE
Source Publication Considerations
FDA makes a noteworthy change in the final guidance by not preserving the 2023 drafted standard that source publications should provide “clinically relevant” information. Industry members submitted comments that this element of the SIUU analysis was too subjective and challenging to implement. Instead, FDA preserves only a “scientifically sound” standard that will likely give companies more flexibility in how they can align with FDA’s recommendations. Accordingly, FDA recommends the following:
- Source publications that firms include in SIUU communications should detail studies and analyses that are scientifically sound.
- Firms should take into account existing scientific knowledge to determine whether a source publication is appropriate to include in an SIUU communication.
- Any conclusions articulated in a source publication should align with the prespecified hypothesis or research question from the described study or analysis and be supported by the results from that study or analysis.
With the removal of the “clinically relevant” standard, FDA has assuaged industry frustration over the previous language that would have limited the use of “early-stage” clinical data (including Phase II) and recommended against the use of certain studies, including those without an adequate comparison or control group. These forms of data likely wouldn’t have met the drafted “clinically relevant” standard but can be considered scientifically sound under the final guidance.
Presentational Considerations to Take Into Account
While FDA allows companies to communicate off-label drug uses, the 2023 draft guidance left the industry feeling vulnerable to prosecution if the agency considered their communications promotional in nature. Therefore, the final guidance clarified that communications that “encourage the unapproved use of the firm’s medical product based on elements other than the communication’s scientific content” do not fall within FDA’s enforcement policy on SIUU communications. SIUU communications should instead:
- Clearly and prominently present the disclosures recommended in the guidance (e.g., use audio and visual components to help HCPs notice and comprehend the information)
- Be separate from promotional communications about approved uses of medical products (e.g., use a web page for SIUU communications and a separate web page for promotional communications about the approved uses)
- Be shared through media and via platforms that enable firms to implement the recommendations in this guidance (e.g., certain online platforms may impose character-space limitations that would not permit a firm to include all of the disclosures recommended).
These recommendations show a significant shift from the 2023 draft guidance by completely omitting language that suggested SIUU communications “should not use persuasive marketing techniques” and firms should differentiate channels for SIUU communications from promotional activities to reduce any risk. This is a direct result of trade groups and pharmaceutical companies pushing back against the draft guidance and providing comments stating that FDA failed to clearly describe what the agency considers to be “persuasive marketing techniques.” The final guidance’s change in language should certainly prove beneficial to medical product companies.
Additional Recommendations for Digital Clinical Practice Resources
Prior to FDA’s 2023 draft guidance, the agency had advised firms not to emphasize portions of scientific articles suggesting the safety or efficacy of off-label uses when disseminating medical publications. Pharmaceutical companies and trade groups were concerned that the draft guidance only allowed firm-created presentations based on article reprints. In the final guidance, FDA clarifies that presentations are no longer restricted to reprints only, but firms can now summarize Clinical Practice Guidelines, reference texts, and materials from digital clinical practice resources that are included in an SIUU communication.
Recommendations for Firm-Generated Presentations
Some firms develop firm-generated presentations to include in their SIUU communications, which involve additional considerations since the firms themselves are creating the communications. The final guidance recommends that a firm-generated presentation have all of the following characteristics if a firm chooses to include it in an SIUU communication:
- Be limited to the SIUU from one or more source publications and be consistent with the other recommendations of this guidance
- Provide the source publication(s) with the presentation
- Include all information material to the representations made
- Clearly disclose what portions of the SIUU communication are firm generated (e.g., “This presentation was developed by FIRM X”).
These recommendations solidify FDA’s shift toward allowing firms to summarize scientific findings when disseminating medical journal articles to HCPs, which the 2023 draft guidance had newly suggested.
Additionally, after demands for clarity from industry members, the final guidance provides examples of promotional communication techniques that fall outside of the final guidance’s enforcement policy, which include celebrity endorsements, premium offers, and promotional tag lines.
KEY TAKEAWAYS
- The final guidance appears balanced more towards pharmaceutical companies’ and trade groups’ interests following heavy pushback against the draft version. This final guidance focuses on the industries interests in HCPs receiving SIUU of approved or cleared medical products to inform clinical practice decisions for the care and management of individual patients with the various government interests in incentivizing the development and satisfaction of premarket requirements for medical products.
- In firm-generated presentations, FDA no longer limits SIUU communications to information from an accompanying reprint. However, using promotional communication techniques to encourage the unapproved use of a firm’s medical product based on elements other than the communication’s scientific content does not appropriately serve the purpose of informing clinical practice decisions for the care and management of individual patients and is therefore excluded from FDA’s enforcement policy on SIUU communications.
If you have questions about how FDA’s final guidance on SIUU communications could impact your business, please contact a member of McDermott’s Food, Drug & Medical Device Regulatory Group.
