OFFICE OF DRUG SAFETY RELEASES FISCAL 2003 ANNUAL REPORT

A key objective of the FDA's Office of Drug Safety (ODS) in fiscal 2003 was to develop a more cohesive working relationship with the review division staff in the Office of New Drugs (OND), according to ODS, which has come under attack recently for allegedly being too close to OND.

In its annual report released Dec. 28, 2004, ODS highlighted its accomplishments from Oct. 1, 2002, to Sept. 30, 2003. The report didn't cover recent drug safety controversies, including suicide risks associated with antidepressant use in children and Merck's sudden withdrawal of its arthritis pain drug Vioxx (rofecoxib) after studies linked it to increased risks of heart attack and stroke.

Significant fiscal 2003 accomplishments, according to the report, included developing the proposed rule on bar-code requirements for human drug products and blood; developing the Safety Reporting Requirements for Human Drug and Biological Products Proposed Rule; assuming a new role in the review of postmarketing safety data to develop programs to manage the risks of drug products beyond the information located on the products' labeling; providing safety reviews of all drugs that were granted pediatric exclusivity by the Center for Drug Evaluation and Research; and developing software to aid in the premarket identification of drug and/or biologic names that look and sound like proposed proprietary drug names.

ODS added that it plays a pivotal role in protecting the public's safety by working closely with OND in developing and evaluating risk-management programs designed to encourage the safe use of drug products and in tracking how drugs are used by patients and prescribed by physicians.

ODS' fiscal 2003 report is available online at http://www.fda.gov/cder/Offices/ODS/AnnRep2003/default.htm (http://www.fda.gov/cder/Offices/ODS/AnnRep2003/default.htm).