Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?

At the end of June, the FDA sent a Notice of Violation (NOV) letter to Dr. C (you can find his name in the letter), Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).Here's the ad in question:Unless Dr. C (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C Act.Anyone, such as Dr. C, who is a regulatory authority -- he's worked in a regulatory capacity for several pharma companies since 2004 -- should be aware of FDA's "received precedent" on this type of ad (i.e, 14 warning letters issued in April 2009).VIREAD is associated with serious risks and includes a black box warning. To advertise such a drug without providing any mention of such risk is unconscionable.But there are even more serious problems with this ad, that, IMHO, should get Dr. C in hot water with Gilead's CEO!Read more ยป
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: 14 letters FDA Girl from Google Legal/Regulatory Source Type: blogs