For the second time in 16 months, Food and Drug Administration officials have ordered Gilead Sciences Inc. to stop downplaying the risks and exaggerating the benefits of its hot-selling AIDS drug, Viread.
In a warning letter to the biotechnology company, the FDA said Gilead sales representatives repeatedly violated regulations at an AIDS conference in Miami this year by making false and misleading statements about Viread and making no mention of the “serious risks associated with the drug.”
The actions by Gilead employees raise “significant public health and safety concerns” and are “particularly troubling” because the company had been issued a similar warning in late March 2002 after a Gilead sales representative told an FDA official at a Chicago conference that Viread was “a miracle drug,” according to the letter.
Thomas Abrams, director of the FDA’s division of drug marketing, advertising and communications, sent the warning to Gilead Chief Executive John C. Martin on July 29, and it was posted on the FDA’s Web site Thursday. Gilead must file a response to the FDA’s letter by Tuesday or face regulatory action, “including seizure or injunction” without further notice.
Amy Flood, spokeswoman for Foster City, Calif.-based Gilead, called the misstatements in Miami “an isolated incident.” She added, “This is something we take very seriously, and we are going to be responding to the issues they outlined in the letter.”
Viread, a once-daily HIV pill meant to be used with other treatments, was introduced in 2001 and is expected to top $500 million in sales this year.
In discussing Viread at the Miami conference, a Gilead salesperson said the drug was more potent, has fewer side effects and is safer than competing drugs that are chemically similar and also help block HIV from replicating itself, according to the FDA letter. Abrams told Gilead that the FDA was “not aware of any data from head-to-head clinical trials to substantiate claims of more favorable safety or efficacy with Viread over other drug products.”
Gilead’s shares rose $1.24 to $62.63 in Nasdaq trading Thursday. The stock has climbed 84% this year.