Last month, the US Food and Drug Administration (FDA) released its latest guidance, Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers. In this final guidance, the FDA describes recommendations for medical product manufacturers intending to disseminate or discuss scientific information contained in reprints, clinical practice guidelines, reference texts, or digital clinical practice resources about unapproved uses of approved or cleared medical products.

It represents the final version of draft guidance that the agency released in 2023, and it updates FDA’s collection of guidance documents on the topic, including its 2014 draft guidance, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices.

The changes from the draft guidance have been characterized as offering a more permissive policy that facilitates critical scientific exchange within the life sciences industry. The agency had faced First Amendment concerns about chilling speech that were raised in numerous comments made on the draft version by industry participants and have their roots, at least in part, in a 1998 case decision.

Some of the relaxed standards

In the latest guidance, the FDA updates its framework for communicating scientific information about unapproved uses of approved or cleared medical products to healthcare providers (HCPs). And it outlines its enforcement policy and recommendations to ensure that such communications are informative, truthful, and non-misleading.

By expanding the scope, and clarifying important definitions, including scientific information on unapproved uses of a medical product (SIUU), the new guidance clarifies the definitions and parameters of the FDA’s policy.

In the draft guidance, the FDA said that SIUU communications should be “based on studies and analyses that are scientifically sound and provide clinically relevant information,” and cautioned against using early-stage clinical data in SIUU communications. It specifically cited instances in which Phase 3 results diverged from Phase 2 results, making Phase 2 data used in such communications misleading or inaccurate.

In the new guidance, though, the FDA loosened its standard, requiring only that SIUU communications be based on studies and analyses that are “statistically sound.”

And the FDA clarified that data from a properly-conducted, early-phase clinical study can be used to form a “scientifically sound” source publication for an SIUU communication, removing its prior language on that topic.

The new guidance is meant to offer manufacturers greater freedom in sourcing supporting information for SIUU communications.

Persuasive marketing techniques

Interestingly, the FDA continues to be spooked out by communications that use so-called “persuasive marketing techniques” or (if you can forgive me my alliteration) “playful product promotion.”

Let’s leave it to the FDA to explain its reasoning here for outlawing the gimmicky promos.

“In FDA’s experience, when the following communication techniques are used, in most cases, that use is to influence decisions based on elements other than the communication’s substance: celebrity endorsements, emotional appeals unrelated to the scientific content, gifts, promotional tag lines, jingles, and premium offers.”

Additionally, the guidance does not extend to calls to value that pre-judge the benefits of the medical product for individual patients. Examples of calls to value that pre-judge the benefit(s) of the medical product for individual patients include: “Call FIRM X now for more information on [Medical product X] – it’s the best option for your difficult-to-treat patients!” and “Click here to start improving your patients’ lives today,” the FDA explained.

Sharing SIUU comms

The FDA explained that SIUU communications can be shared to healthcare providers by anyone with a certain kind of training – so not just scientists and licensed medical professionals.

Any representative from a firm can share it, the FDA says, as long as they have the requisite training in providing truthful, non-misleading scientific information about unapproved uses of the firm’s approved medical products and have had some training in handling potential questions that might arise from the information shared.