In a warning letter dated February 27, FDA accused a Gilead Sciences rep of minimizing risks associated with Letairis – a pulmonary arterial hypertension drug – during a conference last June.
According to the letter, a Gilead rep told conference-goers that Letairis's risk management plan “is only there because of the [drug] class. FDA only issued this because of the class, but this is not that big of a deal. Letairis has a 0.8% incidence of liver enzyme elevations versus 11% at the lowest dose of Tracleer...”
FDA said those statements minimize serious risks, by “misleadingly suggesting that the risks associated with the drug's risk management plan (potential liver injury and the risk of birth defects) do not apply to Letairis.” The drug carries a boxed warning with both risks included. The letter requests that Gilead halt promotional activities that are the same or similar to the rep's statements.
Gilead spokesperson Nathan Kaiser said the company "takes the concerns raised by the FDA regarding Letairis promotional activities very seriously, and is taking immediate action to address this issue through additional retraining of Letairis personnel."
The statements in question were made during the Pulmonary Hypertension Association's International Pulmonary Hypertension Conference and Scientific Sessions, in Houston, Texas. A BNET Pharma report published online today points to the conference's website, where all presentations were taped and are available for replay.