FDA Releases Five-Year Drug Safety Plan

Rockville, MD (Feb. 13)-The US Food and Drug Administration has released its Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan. Approved in December 2008 and posted on the FDA website last week, the plan is meant to modernize the agency's drug-safety program. FDA will increase its staff, evaluate the benefits of using spontaneous adverse-event reports to characterize drug-safety risks, acquire more health-information databases, strengthen risk-management tools, and improve postmarket information technology (IT) systems, according to the plan, which runs FY2008 to FY2012.

The agency plans to increase the staff of the Office of Surveillance and Epidemiology (OSE), which is part of the Center for Drug Evaluation and Research (CDER). OSE staff monitor postmarket adverse-event data, review observational pharmacoepidemiologic study protocols, and perform medication-error analysis and prevention. The new staff will be distributed throughout the office and enhance OSE’s postmarketing safety initiatives.

Like CDER, the Center for Biologics Evaluation and Research (CBER) is taking measures to improve its postmarket safety activities. CBER is increasing the staff in the Office of Biostatistics and Epidemiology, has created interdisciplinary product-safety teams, and will expand resources and staff to access and analyze healthcare databases, according to the plan.

FDA also will seek greater access to external pharmacoepidemiologic data sources that it first obtained in 2005. The agency awarded contracts to Ingenix, Kaiser Foundation Research Institute, the Vanderbilt University, and Harvard Pilgrim Health Care to gain access to information about drug use, patient outcomes, and special populations. FDA contributed funds to large drug-safety studies that investigated issues such as serious cardiovascular effects of drugs to treat attention deficit hyperactivity disorder and the association of thromboembolic events with combined hormonal contraceptive products. FDA will use new PDUFA IV funds to access additional data sources and conduct population-based epidemiological studies. The agency is considering proposals to expand its program to additional sites and will make a decision in fiscal 2009, according to the plan.

In addition, FDA will develop a guidance document about risk evaluation and mitigation strategies (REMS) and safety labeling. The agency will also create a plan to develop Risk Minimization Action Plans (RiskMAPs) and REMS elements. After holding a public workshop to obtain industry input, FDA will assess the effectiveness of various RiskMAPs, REMS, and communication tools.

The PDUFA IV Drug Safety Five-Year Plan is available here.