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U.S. Department of Health and Human Services

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FY 2002 PDUFA Financial Report: Management Challenges for FY 2003

Table of Contents

Previous Section: Total Costs of the Process for the Review of Human Drug Applications

Since 1990, FDA has cut in half the time it takes to evaluate new drugs, while still maintaining its traditional rigorous standards for drug safety and effectiveness. This improvement, coupled with other attractive features of the U. S. market, has led to an increase in the number of new drugs launched first in the U. S. before they are available in other countries, making new therapies available first to Americans. This is a dramatic shift from the previous 20 years in which most new drugs were available in America years after they were available in other countries. Without the funds derived from PDUFA fees, the substantial progress FDA has achieved in improving and expediting the review of human drug applications would not have been possible.

The agency is gratified that Congress and the Administration have worked together with the agency and its stakeholders to achieve timely reauthorization of PDUFA for the next 5 years. On June 12, 2002, the President signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 (PDUFA III) reauthorizing user fees and assuring the continuation and enhancement of the of prescription drug user fee program through FY 2007.

Under PDUFA III a number of changes were made to PDUFA II. A more stable fee structure and increased fee revenues should provide FDA with the resources needed both to continue to meet PDUFA II goals and to embark on several new PDUFA III initiatives aimed at further enhancing the drug review program.

The most significant tactical challenge facing FDA in FY 2003 is the need to hire additional staff for the drug review process, as authorized under PDUFA III. FDA must move quickly to hire additional staff now that FY 2003 appropriations which permit spending fee revenues at the higher levels authorized under PDUFA III have been enacted. The President signed the appropriation act permitting FDA to spend at the higher rates authorized under PDUFA III on February 20, 2003—almost 5 months into the fiscal year. As a result FDA will be able to utilize fewer additional staff years on the drug review process in FY 2003 than originally planned. This reduction in available human resources will challenge FDA in meeting performance goals for FY 2003.

In FY 2003, FDA will continue working toward the goal of receiving more applications, and more parts of applications, electronically. This major change in how FDA does business should provide significant savings to industry. Setting standards and sequencing the development and implementation of the necessary infrastructure to achieve this goal demands careful planning, constant monitoring, and vigilance with respect to newly emerging technologies.

After substantial deliberation, and in an effort to achieve a more efficient, effective, and consistent review program for human drugs and biologics, FDA has decided to move the review of therapeutic biologics from CBER into CDER. The employees to be transferred as a result of this reorganization represent about 31 percent of the CBER employees working on the process for the review of human drug applications, as defined in PDUFA. By organizing the drug development and review process around the disease being treated, informed by specific product and technology expertise, the Agency decision process for these products can be made not only more consistent, but also more patient-centered and science-based. As anyone who has gone through organizational changes knows, the initial process creates understandable anxieties and uncertainties. In FY 2003 we will be challenged to prepare for the implementation of this reorganization, and actually begin the process, while maintaining and improving review quality, consistency and integrity. The Commissioner is committed to the enhanced review process that will result from this organizational change.

In FY 2003, FDA will also begin the implementation of the new provisions of PDUFA III that permit using fee revenue to support certain risk management activities. This represents a change in how these revenues may be used, and an opportunity for the agency to enhance patient safety and work proactively to manage risks and reduce preventable adverse events.

FDA will continue to be challenged by the need to hire, train, and retain qualified reviewers in FY 2003. FDA’s experienced reviewers are in demand and have excellent employment opportunities available to them. The agency experienced staff attrition of over 9 percent in FY 2002 in some major review disciplines in CDER (medical officers, consumer safety officers, and microbiologists). FDA has implemented a number of initiatives to reduce this attrition, including not only retention bonuses for reviewer mathematicians and statisticians but also efforts to facilitate review work from alternative work sites. Retaining review staff and recruiting and training new review staff is a constant challenge. Yet the agency’s ability to attract and retain the best and the brightest in medicine and science is critical to maintaining the FDA’s recognized gold standard in new product safety. Recruiting and retaining top rate professional staff is among the Commissioner’s highest priorities.

Next Section: Appendix A: Conditions for Assessment and Use of Fees