|Footnotes for this article are available at the end of this page.
The Food and Drug Administration’s Office of Prescription Drug Promotion isn’t letting the Dog Days of Summer stop it from taking action against what it perceives as unlawful marketing. In its first Untitled Letter of 2020 and second letter this year (a Warning Letter was issued in February), OPDP took exception to a television advertisement that it claimed made misleading statements about the drug product’s efficacy and minimized risk information.1
We will not describe in this Bulletin the particular facts described in the Untitled Letter, but will highlight OPDP’s concerns:
- The TV ad failed to include certain risk information about a specific contraindication and particular warnings and precautions, described in the product labeling.
- While the commercial provided a specific contraindication, it did not include “Material facts about the consequences that may result from the use of the drug,” and it omitted several material facts.
- Due to the aforementioned omissions of risks, OPDP said that the ad suggested the drug was safer than it had demonstrated.
- OPDP also contended that the ad made misleading claims about the drug’s efficacy. Specifically, the commercial claimed about the drug product (a pre-filled syringe): “Easy to use. Easy to know you did it right. Pretty easy, huh?” However, FDA said that, in the labeling, there were multiple steps in the preparation and administration of the product, and the user should become familiar with the information before an emergency occurs. In addition, OPDP noted that there was no signal for the user to know the product was administered correctly, i.e., “did it right.” Therefore, in FDA’s opinion, the references to “easy” and “know you did it right” were misleading and not supported.
- Finally, OPDP found the ad misleading, because it omitted material facts by, for example, not providing information about the seriousness of the condition (the commercial included early, mild symptoms of the medical condition but not the severe symptoms for which the product was indicated).
- It is our understanding that the TV ad is no longer running. To OPDP, it is irrelevant. The promotion occurred. The proverbial damage was done and must now be fixed and cannot happen again.
- The Untitled Letter focused completely on issues of “misbranding” and concerns about misleading claims. Off-label promotion and First Amendment issues were not present here.
- While the Untitled Letter did not rise to a Warning Letter, OPDP noted its concerns about patient safety and risk information (or lack thereof). This is not surprising; FDA is a public health organization, and such issues will always be the agency’s primary focus when it comes to review of promotional claims.
- OPDP referred numerous times to the product’s Prescribing Information and what was missing in the TV ad. We sit on a number of Promotional Review Committees as the Legal representative. There is often discussion about “how much” risk information to include in promotional materials. There are always “space challenges,” whether in digital media, trade show booths or otherwise. If a company chooses not to include risk information described in the PI (e.g., Warnings, Precautions, or Contraindications) in a specific marketing piece or promotional venue, there should be a dialogue internally what, if anything, to exclude and whether that omission could be sufficiently “material” to invite FDA or product liability scrutiny.
- The Untitled Letter is a reminder not only to include all Contraindications and the most serious Warnings and Precautions in promotion, but also material information from the PI about consequences that may result from the Contraindications and most serious risks.
- “Easy to use” claims will likely be viewed as misleading if the instructions for use contain multiple steps and the claim is not supported by data.
- We believe that OPDP’s concern was heightened because of the particular product’s use in an emergency and the potential need to be administered by others because the patient may be unconscious. The lack of material facts with this product’s unique fact-pattern, in our opinion, likely drew FDA’s scrutiny. Therefore, while all companies should be cognizant of providing “material” risk information, those companies that promote products that are used in emergencies might want to pay extra attention in light of this Untitled Letter.
As the Summer is coming to an end, it looks like OPDP is returning to remind industry that school is always in session.
Alan G. Minsk is a partner and leader of Arnall Golden Gregory’s Food & Drug practice team.
Seth S. Ray is an of counsel of Arnall Golden Gregory’s Food and Drug team and Healthcare practices. Seth was Counsel at the FDA’s Office of Chief Counsel for more than 20 years and also served in the Office of Prescription Drug Promotion.
 The Untitled Letter can be accessed at www.fda.gov/media/141347/download.