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FDA Releases New Draft Guidance for Unapproved Uses

The FDA has released a new draft guidance for communications with health care providers (HCPs) regarding unapproved uses of drugs and devices that are commercially available. This is a reissue of a draft guidance published in 2014 and presents several significant changes, such as that real-world data (RWD) may serve as scientifically sound information for communications with HCPs.

In its final form, this guidance will apply to pharmaceuticals, biotechnology therapies and medical devices, as well as products regulated by the FDA’s Center for Veterinary Medicine. The draft describes the agency’s approach to regulation of communications by firms to HCPs on scientific information for unapproved uses (SIUU). These communications may consist of one or more of reprints of published scientific or medical journal articles, or presentations of scientific information generated by a manufacturer from an accompanying published reprint.6.13.23 1200x524 px fda food and drug administration concept with icon set with big word or text on center

Another potential source of scientific information is any information that qualifies as a published clinical reference source, including clinical practice guidelines, reference texts, or materials from independent clinical practice resources. Any communications between a firm and an HCP should not only be factual and not misleading, but should also include information that allows the HCP to interpret the strengths and weaknesses of the information. The manufacturer should include materials that aid the HCP in assessing the validity and usefulness of the information, particularly with regard to clinical decision-making for the care of an individual patient.

The FDA stated that any communication that is consistent with the guidance will not by itself be used as evidence of a new intended use for that medical device or drug. The final version of the guidance will not apply to unsolicited requests from HCPs, however. The unsolicited request from an HCP is covered in a separate draft guidance that was released in 2011.

SIUU communications should not include persuasive marketing techniques, such as gifts, celebrity endorsements or offers of premiums. The use of these techniques would be interpreted by the FDA as evidence of an effort to persuade the HCP to use the device or drug in a manner inconsistent with the product’s approved label. Furthermore, SIUU communication should be transmitted to the HCP without any communication that would be promotional in nature. The FDA stated that this practice may conflate the approved and unapproved uses of the product in a manner that may lead a physician or nurse to conclude that the unapproved use has actually been approved by the agency.

Additionally, the draft guidance recommends that the sponsor use dedicated vehicles, channels and venues for sharing SIUU information that are separate from those used for promotional communications. This would reduce the risk that those who receive the information will conflate approved and unapproved uses. If a sponsor uses the same vehicle/channel/venue for SIUU communication, the SIUU information should be marked or otherwise identified as distinct from promotional information to reduce the risk of any such confusion. An example of this practice is the use of a portion of a website for SIUU communications that is separate from the website’s promotional content. These two portions of a website should not link directly to each other.

With regard to conferences and other live events, the draft guidance recommends that the sponsor set up separate booths or other areas in an exhibit hall for SIUU presentations. Where this is not possible, promotional materials and SIUU materials should be clearly marked as such.

A similar set of considerations are addressed in the draft guidance’s discussion of social media, particularly social media platforms that impose character-space limitations. The FDA generally recommends that any such uses of social media provide only a hyperlink to an informational webpage with SIUU, but any such information provided on a social media platform should avoid potentially confusing jargon.

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