You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward

Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product.¹ In particular, OPDP objected to two direct-to-consumer television advertisements about patient “journey forward” experiences, claiming the ads provided false or misleading risk information and failed to submit a Form FDA-2253 at the time of initial publication. Of course, we thought of the 1980 Journey song, “Any Way You Want It.”

• The TV ads provided claims about the product’s use (e.g., migraine) and benefits, but did not include any risk information.

• FDA also noted that the TV ads failed to provide adequate provision (for dissemination of the approved or permitted package labeling in connection with the presentation) or a brief summary (of all required information related to side effects and contraindications).

• The TV ads did not include the material information regarding the full FDA-approved indication (e.g., preventive treatment of migraines in adults).

• The company did not submit a Form FDA-2253 at the time of initial publication.

• Shortly after FDA issued the Untitled Letter, the company responded, and OPDP found the corrections adequate.²
  • The company explained that it had intended to show the TV ads as part of a “complete TV broadcast,” consisting of three components – the first component included disease state information concerning migraines, immediately followed by a second component that was presented in the format of a reminder advertisement for the product, and then the final component was a full product TV segment for the product (including indication and risk information).
  • These components were to be aired on television together in an immediate, sequential fashion, with all three viewed in totality.
  • However, no “complete TV broadcast” was submitted to OPDP.

• In its Close-Out Letter, OPDP noted:
  • the TV ads included a clear beginning, middle, and end to the presentation;
  • the ads began with background music that played throughout; and
  • each of the TV ads appeared as an organized presentation.

• The company acknowledged it did not submit the “complete TV broadcasts” to OPDP and none of the submissions referenced coordination with any other communication.

• The company stopped running the ads.

AGG Observations

• If a company intends to use or show materials together, it should make clear to OPDP in the 2253 Form that it is a package, and explain how each piece will be used individually and in totality.

• It should go without saying to ensure the promotion provides the full indication.

• While the company quickly fixed OPDP’s concerns, and it appears the company intended to provide all of the materials in an immediate, sequential matter, it did not execute properly. And, to quote another Journey classic, “Who’s Crying Now.”

[1] See www.fda.gov/media/155419/download

[2] See www.fda.gov/media/155420/download