Jenkins blamed the lapses on "long-standing limitations in staffing and information technology resources," saying that "competing workload priorities prevented us from the level of oversight and review of the entire portfolio of [postmarketing requirements] and [postmarketing commitments] that we would have desired …With new resources and congressional directives, FDA is committed to ensuring proper drafting and review of the entire portfolio going forward.”
Among the changes, each Center for Drug Evaluation and Research division now has a designated postmarketing study coordinator and a postmarketing study tracking coordinator.
In general, the deputy division director for safety - a position established under the agency's Safety First initiative - has assumed the postmarketing study coordinator job, and the safety regulatory manager will handle postmarketing study tracking. "These people as their full-time job are managing the safety and postmarketing study portfolio for their division," Jenkins said.
According to Jenkins, new policies and procedures are in place to "improve consistency in developing" postmarket requirements and commitments and lead to "better designed studies and trials with effective and realistic time frames for initial completion.” He added that other changes have been made to improved tracking and reviewing, including standardizing policies and procedures across CDER review divisions and offices.
