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On October 23, 2023, the Food and Drug Administration (FDA) published a draft guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, Questions and Answers.” This draft guidance, if finalized, will supersede FDA’s 2014 draft guidance document, “Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices.”
Introduction
This version of the draft guidance discusses FDA’s evolving policy surrounding “Scientific Information on Unapproved Uses Communications” (SIUU Communications), which builds upon the 2014 draft guidance but includes a handful of key differences. The revised draft guidance provides explicit recommendations and examples for SIUU Communications to help firms comply with statutory prohibitions against introducing (or causing the introduction) into interstate commerce a medical product that is intended for a use that has not been approved or cleared by FDA and related regulations and policies. The draft guidance includes specific recommendations regarding the appropriate types of media and content for such communications.
Background
In 2008–2009, FDA issued a draft, and then final, guidance on “good reprint practices” for firms distributing “journal articles” or “scientific or medical reference publications.” In 2014, the agency issued a revised draft guidance expanding the scope of communications with specific recommended standards to include clinical practice guidelines, as well as further guidance on reprints and other issues.
The agency held a public meeting in 2016 to solicit comments on its guidelines for communications regarding unapproved uses. In 2017, following the hearing, FDA published a new memorandum with additional guidance, which was accompanied by a public docket for comment on the issue.
In the preamble to FDA’s final rule on “intended use” in 2021, the agency discussed unapproved use communication at length. The preamble included responses to comments to the proposed rule which cited litigation challenging the agency’s ability to bring enforcement actions against firms that are allegedly promoting off-label uses.
Types of SIUU Communications
The draft guidance categorizes SIUU Communications into three main types:
- Published scientific or medical journal articles (“reprints”).
- Published clinical reference resources, including:
- Clinical practice guidelines (CPGs).
- Scientific or medical reference texts (reference texts).
- Independent clinical practice resources.
- Firm-generated presentations of scientific information from an accompanying published reprint.
Recommendations for SIUU Communications
The draft guidance provides several recommendations for SIUU Communications:
- Clear and Prominent Disclosures: SIUU Communications should clearly and prominently present all disclosures recommended in the guidance.
- Avoid Persuasive Marketing Techniques: SIUU Communications should not use “persuasive marketing techniques.”
- Separation from Promotional Communications: SIUU Communications should be separate and distinct from promotional communications about approved uses of medical products.
- Appropriate Media and Platforms: SIUU Communications should be shared through media and via platforms that enable firms to implement the recommendations in this guidance.
- Use of Plain Language: Firms should consider using plain language in the content they develop for SIUU Communications to facilitate comprehension.
Changes in Guidelines for Reprints
The draft guidance introduces stricter standards for journals used for reprints. Instead of just being “peer-reviewed and published in accordance with the peer-review procedures of the organization” as stated in the 2014 draft guidance, reprints should now be “published in a journal managed by an independent organization with an editorial board comprised of persons who have demonstrated expertise in the subject of the articles under review by the organization (through education or experience), and a publicly stated policy regarding the disclosure of conflicts of interest or biases for all authors, contributors, or editors.” The peer reviewers should also be “experts in the subject of the article, as established by education or experience.”
The draft guidance also provides stricter specifications for determining that a publication is “scientifically sound” and “clinically relevant.” While the 2014 draft guidance allowed for the inclusion of non-clinical research in certain cases, the 2023 version states that sharing articles focused solely on nonclinical studies or analysis would not be consistent with the enforcement policy outlined in the guidance. The 2023 draft guidance also raises concerns about SIUU Communications based on studies without adequate comparison or control groups, isolated case reports, and scientific data generated in early stages of product development.
Conclusion
The draft guidance published by FDA in October 2023 provides detailed recommendations for the communication of unapproved uses of approved or cleared medical products to health care providers. The guidance focuses on SIUU Communications and includes specific recommendations for different types of media and content. The draft guidance builds upon previous guidance documents and reflects FDA’s evolving policy in this area.
Firms should take note of the updated recommendations and ensure compliance with the statutory prohibitions and regulations surrounding the promotion and marketing of medical products. The draft guidance emphasizes the importance of clear and prominent disclosures, avoiding persuasive marketing techniques, and separating SIUU Communications from promotional communications about approved uses. Firms should also consider using plain language and appropriate media and platforms for sharing SIUU Communications.
The draft guidance is currently open for public comment, and firms are encouraged to provide feedback. Foley Hoag is available to assist with any questions or concerns regarding the draft guidance and can provide assistance with comment preparation.