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# FDA Accepts Lilly Ad Explanation
- URL: https://www.fdaweb.com/fda-accepts-lilly-ad-explanation/
- Published: 2022-01-25T12:00:00.000Z
- Updated: 2026-09-14T17:29:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151003

The CDER Office of Prescription Drug Promotion (OPDP) says its concerns about a series of Lilly ads for Emgality (galcanezumab-gnim) injection for subcutaneous use have been satisfactorily answered by the company. OPDP expressed its concerns in a 12/13/21 [Notice of Violation](http://www.fda.gov/media/155419/download?ref=fdaweb.com) that said the TV spots featuring two U.S. Olympics athletes made false or misleading claims and/or representations about the risks associated with the migraine drug and omitted other material facts.

In its 12/21/21 [response](http://www.fda.gov/media/155608/download?ref=fdaweb.com), Lilly explained that the spots involving the athletes were designed to be and were only aired as the first of three sequential ads and that the third ad contained all the appropriate risk and other information. “Given that the full indication and appropriate risk information were provided each time that all three components of the pieces aired on television, Lilly requests that OPDP rescind the untitled letter,” the company said.

In its 1/3 close-out [letter](http://www.fda.gov/media/155420/download?ref=fdaweb.com), OPDP acknowledges and appreciates the company’s statement that “there was an intent to create complete TV broadcasts comprised of three components airing in immediate, sequential fashion. We also acknowledge that Eli Lilly has discontinued use of the ‘complete TV broadcasts’ which included the TV ads (components 1 and 2) cited in the untitled letter. In addition, in response to the untitled letter, Eli Lilly asked (redacted) to remove the TV ads cited in the untitled letter (consisting solely of components 1 and 2) from its Web site…. Therefore, OPDP believes that the concerns contained in the untitled letter have been addressed, and we consider this matter closed.”