A Deeper Look at FDA's 2015 Enforcement of Drug Promotions

As mentioned in a previous post, the FDA's Office of Prescription Drug Promotion (OPDP) issued the fewest ever enforcement letters regarding non-biologic Rx drug promotions in 2015 (read "2015 Was Another Good Year for Orphan Drugs & Pharma Marketers").

Of the 9 letters OPDP sent to drug companies regarding violations, 2 were serious "Warning Letters" and 7 were "Untitled Letters." The following chart shows the Warning vs. Untitled letter trend from 2010 through 2015.

One Warning Letter went to Duchesnay for the promotion of Diclegis via Instagram. FDA cited 2 violations: (1) Omission of Risk Information (see "OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!") and (2) Omission of Material Fact (the post failed to provide material information regarding DICLEGIS’ full approved indication, including important limitations of use). The other Warning Letter went to a Valeant subsidiary for the promotion of Tussicaps. FDA cited 3 violations: (1) Omission of Risk Information, (2) Inadequate Communication of Indication, and (3) Unsubstantiated Claims.

Read more »