CDER Plan Summary
CDER plans for FY 2003 and the subsequent fiscal years authorized in PDUFA III are summarized below, using the PDUFA III goal categories.
Enhanced Staffing & Training
In FY 2003, CDER plans to increase review staffing in support of the Sound Financial Footing initiative. An additional 34 FTEs are planned for this category. The estimated increase is $4.5 million with 83%, $3.7 million, of the total for pay and benefits. The goal of this increase is to achieve a sufficient level of staffing to allow reviewers time to maintain their review workloads and engage in professional development and training opportunities. Under PDUFA II staffing levels did not keep up with increases in workload and therefore reviewers were required to forego some training and professional development activities. This precluded reviewers from pursuing development activities (e.g., training in new technology) that are considered to be essential to support the attainment of PDUFA III goals.
Additional funds will be used to provide training related to PDUFA III activities, including the implementation of new guidance (e.g., Good Review Management Principles and Continuous Marketing Application Pilot Programs). Other training will cover topics such as counter-terrorism efforts, current good manufacturing initiatives, and pediatric labeling information.
The Commissioner has established Efficient Risk Management as one of FDA’s five strategic goals. The goal includes both the new drug review process and oversight after approval. When a drug product is approved, it is impossible to know everything about its safety. Therefore, it is important that we increase the surveillance of the safety of medicines during their first two years on the market (or first three years for drugs with potentially serious safety concerns identified at the time of approval). This increased focus on detection of adverse events and monitoring of risk management programs during the pre-approval period will allow improved safe use of newly approved drugs.
The FY 2003 estimated increase for Risk Management is $5.7 million. CDER plans to hire and support an additional 10 FTEs, an increase of $1.2 million for pay and benefits. The personnel will enforce regulations on postmarketing adverse event reporting to ensure that submitted reports are accurate, timely and complete. Plans also include the development of regulatory strategies and final guidance documents; and inspections to ensure industry compliance with the regulations. The largest portion of the increase, $4.5 million will be utilized for the Adverse Event Reporting System (AERS). Upgrading the reporting format from paper to electronic will expedite the reporting process as well as reduce the cost of receiving and processing a report ($31 per report) by at least half for those submitted electronically.
Efficacy Supplement Resubmissions
CDER plans to hire an additional five FTEs in FY 2003 for Resubmitted Efficacy Supplements. The total estimated increase is $590,000. The additional personnel will be used to achieve the Center’s expedited performance goals.
Continuous Marketing Application
FDA recognizes the importance of providing safe, effective, and high quality drugs to the American public that treat serious and life-threatening diseases as soon as possible. The Continuous Marketing Application (CMA) goal is a new performance goal comprised of two pilot programs that will test whether early review of selected applications and additional feedback and advice to sponsors during drug development will further shorten drug development and review times.
CDER is in the process of developing guidance with CBER on how the pilot program will be implemented. The Center estimates $982,000 will be required to fund the salaries and support of 8 additional Staff years. Personnel will complete the initial phase of the guidance development by the end of FY 2003. The guidance will describe the principles, processes, and procedures of the pilot program as well as other required technical and scientific information.
Independent Expert Consultants
CDER plans to retain independent expert consultants to assist in review of clinical protocols expected to serve as the basis for approval for new biotechnology drugs. CDER will engage these consultants on an ad hoc basis in response to requests from applicants. CDER has developed draft guidance on how this program will be implemented and will work to finalize the guidance. The estimate for FY 2003 is $56,000.
First Cycle Review Performance
FDA plans to develop a joint CDER/CBER guidance on Good Review Management Principles (GRMPs) and publish a guidance by the end of FY 2003 that will address critical principles for the efficient management of the review of new marketing applications. The plan also includes the development and implementation of a training program for all review personnel on the GRMPs. An independent expert consultant will subsequently evaluate issues that pertain to the first cycle reviews. The study will evaluate current performance and changes that occur after the GRMPs guidance is published; an assessment of the first cycle review history of all NDA’s for NME’s during PDUFA III; and the effectiveness of the training program. CDER plans to hire an additional 2 FTEs in FY 2003, a total increase of $295,000.