FDA announces five-year improvement plan

4/7/2008

WASHINGTON The Food and Drug Administration announced a five-year drug safety plan, to hire more people in order to strengthen its post-market drug-safety activities.

According to published reports, with the new plan, known as the “Prescription Drug User Fee Act IV Drug Safety Five-Year Plan,” the agency plans to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors, with its new $29.29 million allowance, which includes a yearly inflation factor as well.

The FDA also plans on increasing its technological capabilities, and focus on improving the drug safety system, which it addressed in its draft; in order to strengthen this aspect of the agency, it would need at least two-to-three years to prepare its new staff to become experts. According to published reports, under the PDUFA IV, the FDA will be able to accept user fees which would be used for REMS, post-market studies, safety labeling changes and active post-market risk identification, according to published reports.

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