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# Intended Use Rule Clarifies Off-label Promotion Implications
- URL: https://www.fdaweb.com/intended-use-rule-clarifies-off-label-promotion-implications/
- Published: 2021-08-09T12:00:00.000Z
- Updated: 2026-09-14T17:09:42.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5149894

FDA’s recent “intended use” [rule](https://www.fdaweb.com/final-rule-amends-intended-use-regs/) and accompanying FDA preamble and response to comments offer important advertising and promotion guidance for pharmaceutical and medical device industries, such as the agency clarifying that it will not determine a firm’s intent regarding off-label use based *solely* on its knowledge that the product involved is being prescribed and used off-label. Writing in a 8/9 [*Legal Update*](https://www.jdsupra.com/legalnews/fda-issues-final-rule-clarifying-3589840/?ref=fdaweb.com), Dechert attorneys caution however, that the agency also makes clear that company knowledge may remain a factor in its overall evaluation of objective intent and that it will look at “any relevant source of evidence.”  

The update points stakeholders to FDA’s response to comments in the final rule’s preamble that the agency will evaluate the question of whether a manufacturer, distributor, or seller has expressed an off-label intended use on a case-by-case basis. “In certain cases, a single piece of evidence may be dispositive,” it says. “Stakeholders should be guided by the FDA’s examples of evidence it may consider. However, the examples provided by the FDA are not exhaustive and companies should routinely evaluate their own and others’ product-related communications and activities to determine whether a reasonable person might perceive that a product has an intended use that is different from what the FDA has approved.”  

Additionally, the attorneys say FDA did not expressly adopt in the final rule a “totality of the evidence” standard for determining a company’s objective intent around product use, but the agency indicates that it has not rejected the concept either. “The FDA makes clear that it will consider a wide range of types of evidence in determining intended use, including express promotional claims and representations, implied claims, product characteristics and design, and the circumstances of the product’s sale or distribution,” they write.