FDA Says Off-Label Communications That Are “Consistent” With the Approved Label Are Acceptable


The US Food and Drug Administration (FDA) has released draft guidance that address questions about how pharmaceutical companies can share off-label communications that are “consistent” with the approved label.


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The pharmaceutical industry has been lobbying for clarity from the FDA about off-label communications for many years. The FDA has faced several lawsuits concerning the rights of these companies to share truthful and non-misleading information about its products that stray from the FDA-approved label. With their recent draft guidance, the FDA hopes to alleviate any questions or concerns about off-label communications through detailed lists of acceptable and unacceptable off-label information.

The FDA has cited 8 examples of ways pharmaceutical companies can share information while staying “consistent” with a product’s approved labeling: information concerning comparisons with other medical products; information about adverse effects of products; information about the onset of action and dosing regimen of a product; information about long-term safety and efficacy of a product; information about effects of a product in a specific patient subgroup included in the approved patient population; information about patient-reported outcomes after use of a product; information concerning product convenience; and information that provides additional context about the mechanism of action described in the labeling.

Examples of unacceptable information, as written in the draft guidance, include use of products to treat different diseases or patients not included in the approval, use of a product through a different route of administration not included in the approval, and use of a product in a different dosage form not included in the approval.

In a concluding section about what companies should consider when developing off-label communications, the FDA wrote that any study results and other data that support a company’s communications needs to be “accurately represented.” The FDA also wrote that off-label communications should contextualize relevant information about a product “including by disclosing unfavorable or inconsistent findings.”

Yesterday, the FDA opened a 90-day comment period on the draft guidance.