It’s a repeat offense for sleep drug Doral. The FDA's ad watchdog, the Office of Prescription Drug Promotion (OPDP), slapped Galt Pharmaceuticals with a warning letter in September about an email it sent to physicians that omits serious drug risks.
It’s the second time OPDP has flagged Doral marketing. It previously sent an untitled letter in 2014 to then-Doral marketer Sciecure Pharma for a professional sales aid about missing risk information and material facts that had been omitted.
In the newest letter (PDF), OPDP expressed its concern about the recurrence, saying, “While Sciecure is no longer the application holder, OPDP is concerned that Galt is continuing to promote this product in a similarly violative manner.”
The Doral warning letter is the second of the more serious category of "warning" letter for 2019, although five untitled letters have also been delivered. That brings the total pharma marketing violations to seven notched by the FDA so far this year.
The latest untitled letter (PDF), sent recently, dinged Kowa Pharmaceuticals for cholesterol fighter Livalo and a DTC patient testimonial video on its website the FDA said understates side effects. It also pointed out that the patient testimonials “compete for the viewers’ attention,” making it difficult to properly assess risks.
While OPDP letters to pharma companies have slowed in the past few years, September was busy by comparison with two letters sent. The seven letters so far in 2019 ties last year’s total. OPDP sent five letters in 2017, 11 in 2016 and nine in 2015.