The FDA plans to spend 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, according to FDA News. The details are spelled out in a draft called ‘PDUFA IV Drug-Safety Five-Year Plan.’

The agency add risk-management experts responsible for reviewing proposed and implemented Risk Minimization Action Plans or Risk Evaluation and Mitigation Strategies, or REMS, and upgrade its technological capabilities and communications as it improves its drug-safety system. According to a 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 nearly $30 million annually plus a yearly inflation factor to increase its drug-safety capabilities.