FDA Releases Five-Year Drug Safety Plan
ePT--the Electronic Newsletter of Pharmaceutical Technology
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
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.