Two for Tuesday: FDA Issues Two Warning Letters on the Same Day for Unlawful Drug Promotion
|Footnotes for this article are available at the end of this page.|
Some of us remember radio stations playing two songs from the same artist or band, back to back, with the alliterative “Two for Tuesday” slogan. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) played disc jockey on September 22, 2020, and issued two Warning Letters for unlawful drug promotion1, with FDA expressing many similar concerns in both. OPDP has picked up the pace recently with the issuance of letters, and we have described these previously in other AGG Bulletins. And the beat goes on.
We will summarize some of the key points and emphasize what we think are the more relevant takeaways.
Highlights and AGG Observations
- One Warning Letter related to a New Drug Application (NDA) product and another to an Abbreviated New Drug Application (ANDA) product.
- Both OPDP letters were the subject of complaints to the Bad Ad Program.
- Both promotional pieces lacked any risk information.
- One promotion involved emails that sales representatives sent to doctors about the product’s use to treat symptoms of COVID-19 (an unapproved use); the other promotion was a Google-sponsored link for a Black Box Warning product.
- The sponsored link referred the user to “View Important Safety Info & Boxed Warning,” but OPDP said this was insufficient. The link also failed to include material information from the full approved indication in the Indications and Usage section. Finally, this promotion included messaging that was misleading when contrasted with the Clinical Studies section of the Prescribing Information.
- The OPDP had expressed concerns in the past (in an Untitled Letter) about the promotion of the Black Box Warning product to the previous application holder. FDA said “We are concerned that [company] is continuing promotion of [product] in a manner that similarly fails to adequately convey risk information.” (Emphasis added.)
- FDA requested that the corrective messaging should use the same media, “and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.”
 The Warning Letters can be accessed at: www.fda.gov/media/142585/download and www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/currax-pharmaceuticals-llc-610942-09222020
- Alan G. Minsk