Just as the Obama Administration came to a close, the U.S. Food and Drug Administration (FDA) delivered on its promise to provide industry with clarifying guidance regarding on-label product communications. The Draft Guidance (http://bit.ly/2n0rfK8) was jointly issued by the FDA’s Centers for drugs, biologics, medical devices, and animal drugs and gives insights on communications the FDA views as truthful, non-misleading, and “consistent” with a product’s FDA-required labeling. Notably, the FDA says it examines product communications based on whether the communication: (1) includes a new use or patient population, aligns with limitations and directions for use noted in the labeling, or suggests a new dosage strength, regimen, or route of administration; (2) increases harm to public health; or (3) requires new directions for use to ensure product safety and efficacy. Tripping up any one of these three factors can deem a communication inconsistent with FDA-required labeling or “off-label.” However, the FDA gives numerous examples of communications that could be permissible on-label promotion, answering many questions industry has raised in recent years about the use of new data, long-term data, subpopulation data, and more. Some key takeaways from FDA’s Draft Guidance:
- Presenting data not reflected in FDA-required labeling, alone, will not a make a communication off-label, provided none of the three factors is tripped.
- Prominently disclosing a study’s design, limitations, and other material information when presenting new data can be the difference between an on-label and off-label communication.
- Head-to-head comparative data for products with the same indication can support a product comparison, and the FDA leaves open the possibility that non-head-to-head data can as well.
- Providing qualifying information for adverse reactions may be consistent with product labeling and may not minimize product safety information (e.g., for a product with a nausea side effect, information on how taking the product with food may reduce nausea may be appropriate).
- Onset of action data versus control under approved use and administration conditions may be appropriate to present if the product labeling only discusses onset in terms of the study’s endpoint.
- Long-term data may be consistent with the label but only when the product is indicated for chronic use.
- Subgroup data may be presented if the subgroup is part of the approved/cleared use population.
- Patient-reported outcomes data may be presented when the product is used as labeled in the approved population.
- Convenient dosing schedules/regimens are appropriate to present when the product has a long duration of effect.
- Additional details about the mechanism of action can be on-label if they are grounded in information included in the product labeling.
- Any data presented should be “scientifically appropriate and statistically sound” and presented with appropriate context.
Until the FDA signals otherwise in revised guidance or enforcement actions taken by the new administration, industry would be wise to adhere to the FDA’s current thinking on appropriate parameters for on-label communications.