GlaxoSmithKline Philadelphia, PA (1/31). Reviewed a convention panel for Coreg tablets submitted by the firm and displayed at the 2004 American Society of Health-System Pharmacists conference 6/19-23/04. Misbranded: DDMAC says the panel is false or misleading because it omits material risk information and overstates the efficacy of Coreg. The panel overstates efficacy because it includes a large bolded header “Broad-spectrum blockade, proven cardioprotection” followed by a graphic presentation that includes hypertension, coronary artery disease (CAD), previous myocardial infarction (MI), and diabetes. DDMAC says that because the graphic is presented in conjunction with the header and the presentation of reduction of mortality and disease progression in specific patient populations, it may suggest that Coreg has demonstrated a cardioprotective benefit in hypertensive patients and specific subsets of hypertensive patients (CAD, previous MI, and diabetes). However, DDMAC points out, none of Coreg’s trials specifically evaluated hypertensive patients or specific subsets because hypertension was not an inclusion criterion for trial enrollment, etc. (Coreg); FDCA 352(a), (n), and 321(n) (No Code)]
http://www.fda.gov/foi/warning_letters/g5177d.pdf
Marcum, John Childrens Hospital Los Angeles, CA (1/27). Inspected 9/8-23/04. Clinical investigator violations: The investigator’s plan/protocol required prompt reporting of significant adverse events to the IRB in writing within five days of occurrence and within 24 hours of serious events. Yet there were nine subjects in the study who developed serious infections that were not reporting to the IRB within five days. Also there were four deaths that were not reported to the IRB within 24 hours. The devices under investigation were not properly controlled in that test articles were stored in various offices and the investigators did not always have knowledge of exactly when the test articles were removed after (purged). Investigator had no records to indicate the date, the amount, or lot number of devices received. Records of each subject’s case history are not all accurate, etc. (device study); 21CFR 812.100, 812.110(b), 812.5, 812.150(a)(1), 812.140(a) (No Code)
http://www.fda.gov/foi/warning_letters/g5176d.pdf
