Gilead's FDA Warning Letter Contains Lesson About the Internet
Gilead learned a lesson about the internet this week, namely that everything on it lives forever. Gilead received a warning letter from the FDA citing “false or misleading” statements about pulmonary hypertension drug Letairis made by one of its representatives at a medical conference. The letter was dated Feb. 27, but the incident it refers to was on June 20, 2008:
On Friday, June 20, 2008, at approximately 12:00 p.m., during the 2008 Pulmonary Hypertension Association International Pulmonary Hypertension Conference and Scientific Sessions in Houston, Texas, a Gilead representative stated:
‘The [Letairis] risk management plan is only there because of the class. FDA only issued this because of the class, but this is not that big of a deal…’
Contrary to the representative’s statements, the risk management program for Letairis was developed because of the risks associated with Letairis itself
Ouch! The FDA said it found the violation “as part of its routine monitoring and surveillance program.” So, was an FDA spy in the audience? And if so why did he or she wait eight months to get the FDA letter sent?
Probably not. Rather, the entire conference was taped and is available for anyone who want to listen at this site.
In fact, many of the sessions start with a moderator reminding panelists that the sessions are being taped. (At one session, there was even a joke about it. One doctor panelist says “If anything I say…” and is then interrupted by another, who quips, “It will be used against you!”)
Gilead did indeed have friends at the conference. For instance, at the panel on “Changing to Different PH Medications: Important Things to Know Before, During & After,” Gilead had funded one panelist, Dr. David B. Badesch of the University of Colorado Health Sciences Center. Three of the other four panelists had been investigators on a study that “received grant support from Gilead.” You can search for their names here. Small world!
(For the record: None of the people on this panel were the ones that made the misleading statement.)
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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