August 3, 2004
Public Citizen Calls for Criminal Investigation of AstraZeneca
Company Illegally Delayed Submitting Reports of Serious Adverse Reactions to Cholesterol Drug Crestor
WASHINGTON, D.C. – Public Citizen today called on the U.S. Food and Drug Administration (FDA) to investigate AstraZeneca for illegally delaying the submission of reports of serious adverse reactions to the cholesterol drug Crestor.
The company delayed the submission to the FDA of 23 such reports, with some delays being as long as 97 days beyond the 15-day reporting limit, said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, in a letter to FDA’s Acting Commissioner Lester Crawford. The delay hampered the FDA’s ability to assess the safety of what is a “uniquely dangerous drug,” Wolfe wrote.
“For months the FDA did not have an accurate count of reported cases,” Wolfe wrote. “Such apparently criminal behavior by a major drug company severely impairs the FDA’s ability to promptly and accurately evaluate the safety of marketed drugs.”
Since Crestor went on the market in September 2003, some patients taking it have suffered severe muscle deterioration, kidney failure or kidney insufficiency. In 20 of the 23 cases that AstraZeneca delayed reporting, patients taking the drug were hospitalized. (Nineteen of the 23 cases involved muscle deterioration and four involved renal failure.) Public Citizen has petitioned the FDA to remove Crestor from the market.
The Food, Drug and Cosmetic Act requires drug companies to report these kinds of adverse reactions “as soon as possible” but not later than 15 calendar days after the initial receipt of the information. Criminal penalties for violating the act with the intent to mislead include up to three years in prison and a $10,000 fine.
AstraZeneca reported these 23 cases to the FDA only in quarterly reports filed on March 5 and July 2. However, quarterly reports are supposed to be used for adverse reactions that don’t fall into the 15-day category, which covers adverse reactions that are both serious and unexpected.
“We continue to urge the prompt removal of this uniquely dangerous drug from the market and believe that your investigation is likely to uncover further reasons to do so,” Wolfe wrote. To read his letter, click here.