FDA Says Abbott Laboratories Failed to Report Adverse Drug Events for Several Drugs, Including Its Antiretroviral Norvir

The FDA has informed Abbott Laboratories that the pharmaceutical company violated federal regulations by "failing to report" adverse events related to several treatments -- the prescription diet drug Meridia, the antibiotic Biaxin and the antiretroviral Norvir, the Washington Post reports (Kaufman, Washington Post, 8/7). In a July 19 letter made public Tuesday, the FDA said that Abbott failed to meet the agency's 15-day deadline for adverse drug event reports 18 times between Jan. 1, 2000, and Oct. 31, 2001 (Horvath/Carey, Wall Street Journal, 8/7). The letter said that Abbott did not report information "properly" about seven deaths associated with Meridia, failed to report one death and "incompletely reported" three other deaths (Washington Post, 8/7). An Abbott spokesperson attributed the problems to the process of "integration of reporting systems" between Abbott and subsidiary Knoll Pharmaceuticals, which Abbott purchased last year from BASF (Bloomberg News/Los Angeles Times, 8/7). Abbott spokesperson Jennifer Smoter said that the problems identified by the FDA occurred before Abbott purchased Knoll, which developed Meridia (Washington Post, 8/7). Abbott officials said that the company has implemented a number of information system improvements and has increased training for employees who report adverse drug events to the FDA. They said that Abbott would respond to the letter within the required 15 days and would discuss with the FDA whether the company must take additional action to address the problems identified in the letter (Wall Street Journal, 8/7). The FDA letter said, "Although your firm has taken some corrective actions, you have not addressed many of our concerns." The FDA letter did not question the safety of Abbott's treatments (Washington Post, 8/7).