FDA again orders Gilead to stop downplaying Viread's risks
BY Advocate.com Editors
August 08 2003 11:00 PM ET
The Food and Drug Administration this week for the second time in 16 months ordered Gilead Sciences to stop downplaying the risks and inflating the benefits of its HIV nucleotide reverse transcriptase inhibitor Viread, the Los Angeles Times reports. The FDA wrote to Gilead officials that company representatives at an April AIDS conference claimed the drug could be used in a broader range of patients than indicated and downplayed the risks of acid accumulation and severe liver enlargement linked to Viread use. Company representatives also claimed at the conference that Viread is better, safer, and has fewer side effects than similar anti-HIV medications, claims which the FDA says are not supported by data from head-to-head clinical trials of anti-HIV drugs.
The company was previously warned in March 2002 to stop claiming that Viread had no toxicities and that it was more effective than other anti-HIV medications. Gilead is now required to respond in writing to the FDA by August 12 with details of its plans to retrain its sales force to stop making inaccurate claims about the drugs and other steps the company will take to identify and correct the violations. A Gilead spokeswoman said the company believes the violations were an isolated incident and that the company will submit a full report to the FDA by the August 12 deadline.