5:47 AM
Jun 12, 2018
 |  BC Extra  |  Politics & Policy

FDA provides guardrails for communicating beyond the label

FDA published guidance Tuesday about manufacturer communication of information that is consistent with, but is not contained in, an FDA-approved label.

The agency stated in the guidance that communications consistent with a label will not be considered promotion of a new intended use. Promotion of a new intended use can lead to prosecution for illegal off-label promotion.

FDA will take three factors into consideration when determining if communication is consistent with an approved label: consistency with conditions of use on the approved label; potential for communication to “increase the potential for harm to health relative to the information reflected in the FDA-required labeling;” and whether “the directions for use in the FDA-required labeling enable the product to be safely and effectively used under the conditions represented/suggested in the product communication."

In regards to conditions of use, FDA will not consider a communication to be consistent with a label if the indication is different, if the communication discusses a patient population that isn’t listed on the label, or if instructions for handling, dosing, regimen or administration are different from those on the label.

FDA provided examples of communications that could be consistent with a label. These included comparing the safety or efficacy of a medical product for its approved indication to another product approved for the same indication, or information that “provides additional context about the adverse reactions associated with the approved uses of the product reflected in the product’s FDA-required labeling.” The agency also highlighted the ability of manufacturers to provide “additional context about the mechanism of action described in the FDA-required labeling.”

In order for communications to be consistent with a label, they must be true and not-misleading, FDA stated. “To be truthful and non-misleading, representations or suggestions made by firms about their products need to be grounded in fact and science and presented with appropriate context.”

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