FDA Releases Five-Year Drug Safety Plan

April 4, 2008

The FDA’s drug centers intend to spend their user fees to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors to enhance their postmarket drug-safety activities.

In its draft, “Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan,” the agency says it will focus on hiring the staff through fiscal year 2009.

It will increase the number of risk-management experts responsible for reviewing proposed and implemented Risk Minimization Action Plans or Risk Evaluation and Mitigation Strategies (REMS). It also will enhance its technological capabilities and communications as it improves its drug-safety system. According to the draft, “it takes at least two to three years of intense training to prepare new staff to be seasoned experts in drug regulation.”

Under the PDUFA IV program, the agency will get $29.29 million annually plus a yearly inflation factor to increase its drug-safety capabilities. It also is authorized to collect user fees to broaden the focus of drug safety. These fees are designated for implementing REMS, postmarket studies, safety labeling changes, active postmarket risk identification and other activities.

The draft plan is available at www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf.