FDA expands scope of off-label guidance to include presentations from reprints

The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses of pharmaceuticals and medical devices.

In the guidance, which was published on 24 October 2023, FDA said it aims to “strike a careful balance between supporting HCP interest in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient, and mitigating the potential that the government interests advanced by these statutory requirements will be undermined.”

FDA prohibits sponsors from disseminating information on products’ unapproved uses, yet notes that “in certain circumstances, however, HCPs may be interested in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient.”

The guidance revises a previous version issued in 2014 (RELATED: Second Reprint Guidance Focuses on Distribution of Safety Analyses, Regulatory Focus 9 June 2014).

The scope of the guidance has been expanded to include firm-generated presentations of scientific information from pubished reprints, as well as materials from independent clinical practice resources. The earlier guidance only addressed dissemination of scientific or medical journal articles, scientific or medical reference texts, and clinical practices guidelines. Other changes include a revised title and a format change to include question and answers.

In a new section, FDA adds information about what presentational considerations firms should take into account for off-label communications. Presentations should “clearly and prominently present all disclosures [on off-label uses] recommended in this guidance,” FDA wrote.

The agency will consider type size, font style, layout, contrast and graphic design, and other factors that give “emphasis” to the disclosures.

FDA also proposes to scrutinize materials from “independent clinical practice resources.” The agency defines this as a “digital resource that contains medical and scientific information on a wide range of topics developed by subject matter experts in various medical specialty fields. The information is typically searchable by topic or keyword and produces materials in response to the HCP’s search terms.”

When a firm shares scientific information on unapproved uses through one or more sections of clinical reference resources, the communication “should include all information from the clinical reference resource necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the information. This may involve the sharing of multiple sections of the clinical reference resource that contain related or linked information,” FDA wrote.

The Pharmaceutical Research and Manufacturers of America (PhRMA) said it is still reviewing the guidance, but noted that that the review of “emerging information” is critical for HCPs.

“Fostering informed communications among all stakeholders is critical. To exercise sound medical judgment in treating patients, health care professionals must understand the full range of treatment options, including both established and emerging information about available medications,” said PhRMA spokesperson Andrew Powaleny.

Powaleny added that PhRMA leaders believe that “the availability of a wider range of truthful and non-misleading information can help health care professionals and payers make better informed medical decisions for their patients, which in turn will benefit patients.”

In the Federal Register notice announcing the revised guidance, FDA asked for feedback on the following questions:

What are the considerations that are unique to communicating scientific information about unapproved uses of approved medical products by firms to researchers, including HCPs working as researchers?
What other factors should be considered when sharing firm-generated presentations to ensure that presentations are truthful and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses of the presented information?

The agency is accepting comments on the draft guidance through 26 December 2023. Comments can be submitted via regulations.gov using docket number FDA-2008-D-0053.

Draft guidance

FDA expands scope of off-label guidance to include presentations from reprints

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