Part 1, Goals (Fourth Section), FY 2003 Annual Performance Plan

U.S. Food and Drug Administration
Performance Plan
2002

Bringing New Technologies To A World-Wide Market

Desired Outcome

To provide quick and safe access to products of new technologies and to enhance U.S. consumer access to these new products, as well as to less expensive generic drugs.

Key Performance Goals

	PDUFA Goal	Actual Performance
FY 1997	90%	100%
FY 1998	90%	100%
FY 1999	90%	100%
FY 2000	90%	100%
FY 2001	90%
FY 2002	90%
FY 2003	90%

	Statutory Goal	Performance
	Statutory Goal	Generic Drugs	Medical Devices
FY 1997	100%	N/A	65%
FY 1998	100%	N/A	79%
FY 1999	100%	28%	74%
FY 2000	100%	56%	96%
FY 2001	100%	50%*	97%
FY 2002	100%	65%*	95%*
FY 2003	100%	75%*	95%*
* Targets

Why is FDA's contribution important?

Pre Market Review

FDA's signature activity and a prime service to the American public is to review the safety and effectiveness of drugs, biologics, feeds, and medical devices before they are allowed on the market. FDA is the regulatory gateway through which the medical products resulting from an estimated $50 billion annual biomedical research and development investment, must pass and be judged.

FDA's primary goal is to reduce the time required for review of new product applications without sacrificing standards of performance and safety. Since 1990, FDA review times for new drugs have been cut in half--from 24 months to less than 12 months. In addition to the obvious health benefits of getting needed drugs to the public much more quickly, faster reviews have also resulted in significant savings to the pharmaceutical industry.

FDA has also approved several thousand generic drugs and medical devices that are used successfully by millions of patients.

Although FDA does place emphasis on expedited review of new products, it is also responsible for overseeing all of the activities that span new product development--from initial research to final market approval. Among the factors that must be monitored and well managed are:

New technologies -- FDA must have a state-of-the-art understanding of the new science and technology that fuels these new products--particularly developments in the biotechnology field--so that review decisions on such products can be based on rigorous science-based standards;

Special population needs--FDA must carefully monitor research and development activities as they progress through the clinical trial stage in order to guide safe and effective products toward populations that need these products, particularly children and the elderly; and
Human Subject Protection--FDA, in cooperation with other health and safety overseers, must ensure that human subjects are adequately protected during clinical trials. There is heightened concern for the rights and welfare of volunteers, given the rapidly changing research environment has led to a proliferation of multi-site clinical trials, an increase in clinical trials using vulnerable populations, and the growth of new types of research, particularly related to genetic therapies and new technologies.

Key Strategies

Pre Market Review

FDA has adopted a number of strategies to improve its product review processes, including:

Continue the Prescription Drug User Fee Act (PDUFA) Program. This initiative has been extremely successful, and serves as a model for reinventing government with all stakeholders working together to achieve performance goals that make a difference to the Nation;
Develop standards for new products of emerging technologies, such as novel drugs and biologics, to facilitate product development, expedite reviews and move products to market faster;
Strengthen external ties. Expeditious medical product review is dependent upon enhanced collaboration and cooperation with industry, academia, professional societies and health care professionals;
Implement a comprehensive quality control system to ensure the Agency's premarket review processes are held to the highest standards. FDA is working with stakeholders to implement this in the least burdensome way;
Continue to prioritize products to increase the efficiency of "fast track" review processes in order to address the most urgent needs for new medical products first; and,
Improve the generic drug review program to reduce review backlogs and review all application within six months.

New Technologies

FDA will continue to increase its expertise in and understanding of new technologies that shape new products submitted for approval. For example, it is anticipated that drug development in the future will be based increasingly on an understanding of the sequencing in the human genome. FDA will have to maintain parallel expertise. At the same time, the Agency must take steps to ensure the safety of these products. For example, FDA and NIH together are committed to establish a gene therapy database that will support collection of short-and long-term effects of gene-transfer products that can be analyzed for safety trends.

Special Populations--Pediatric Medicine

FDA will also implement strategies targeted toward serving special populations with needed new products--particularly children. These strategies stem from provisions contained in The FDA Modernization Act of 1997 (FDAMA). The provisions established economic incentives for industry to conduct pediatric studies in the form of 6 months of 'exclusivity' to be attached to any existing exclusivity or patent protection on a drug for which FDA has requested pediatric studies and where the manufacturer has conducted such studies in accordance with the requirements of FDAMA.

Human Subject Protection

To protect volunteers in clinical research FDA will increase the number of inspections and target high risk clinical trials; increase training for investigators; improve the inspection process for Institutional Review Boards (IRBs); and enhance follow-up compliance activities.

Current Status and Barriers to Further Progress

Pre Market Review For new drugs and biologics, the story is one of great success. FDA has moved from criticisms of a "drug lag" with other countries a decade ago to the current situation in which new drugs are approved in the U.S. as fast or faster than anywhere in the world, with the same high standards Americans expect. This was accomplished largely by the assurance of sufficient scientific staff funded by industry fees that complement appropriated funds.

Approval times for medical devices are also improving. In FY 2000, although FDA received the highest number of applications in years, the average approval of a new medical device took only 12.0 months, in 25 percent less time than in FY 1997.

In the area of generic drugs, recent increases have enabled the program to raise performance targets. Currently, review times are running three times longer than the statutory limit, but the review staff has been augmented to shorten review time.

Animal drug reviews are facing major hurdles because accelerating science and technology associated with these new products require more intensive evaluations. A strongly funded user fee program would help lower these hurdles.

	FY 1990	FY 1995	FY 2000
	Months	Months	Months
Drugs (PDUFA)	23.8	18.7	11.6
Generics	23.0	28.2	18.9
Biologics (PDUFA)	43.8	31.7	16.8
Medical Devices	13.7	25.4	12.0

Pediatric Medicine

The pediatric exclusivity provision has done more to generate clinical studies and useful prescribing information for the pediatric population than any other regulatory or legislative process to date. As a result of this provision, FDA has issued 191 Written Requests as of May 1st asking for over 300 studies that would potentially involve well over 20,000 pediatric patients. The Agency has also issued 31 grants of pediatric exclusivity. However, because of the anticipated significant increase in application supplements requesting exclusivity, the proposed expansion of PDUFA user fees is needed. In addition, the exclusivity provision in FDAMA does not apply to drugs with no remaining exclusivity or patent life. Thus, a number of drugs are on the market for which clinical trials tailored to children have not been conducted.

Specific performance commitments for FY 2002 and FY 2003 and actual performance from FY 2001 are outlined in the table that follows.

Performance Goals Summary

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FY 2001 Performance Report			FY 2002 - 2003 Performance Goals
Program	FY 2001 Goal	FY 2001 Status	FY 2002 Goal	FY 2003 Goal
Premarket Review
Human Drugs Goal 1	Review and act on 70 percent of standard original NDA submissions within 10 months of receipt and 90 percent of priority original NDA submissions within 6 months.	FY 2001: Data available 1/2003 FY 2000: 79 percent of Standard NDAs and 97 percent of Priority NDAs	Review and act on 90 percent of standard original NDA submissions within 10 months of receipt and 90 percent of priority original NDA submissions within 6 months.	Review and act on 90 percent of standard original NDA submissions within 10 months of receipt and 90 percent of priority original NDA submissions within 6 months.
Biologics Goal 1	Review and act on 70 percent of standard original PDUFA NDA/PLA/BLA submissions within 10 months; and review and act on 90 percent of priority original PDUFA NDA/PLA/BLA submissions within 6 months of receipt.	FY 2001: Data available 9/2002 and 5/2002 FY 2000: 100 percent of Standard NDA/PLA/BLAs and 100 percent of Priority NDAs/PLA/BLAs	Review and act on 90 percent of standard original PDUFA NDA/PLA/BLA submissions within 10 months; and review and act on 90 percent of priority original PDUFA NDA/PLA/BLA submissions within 6 months of receipt.	Review and act on 90 percent of standard original PDUFA NDA/PLA/BLA submissions within 10 months; and review and act on 90 percent of priority original PDUFA NDA/PLA/BLA submissions within 6 months of receipt.
Biologics Goal 2	Review and act on 70 percent of standard PDUFA efficacy supplements within 10 months; and review and act on 90 percent of priority PDUFA efficacy supplements within 6 months of receipt.	FY 2001: Data available 9/2002 and 5/2002 FY 2000: 100 percent of Standard efficacy supplements and 100 percent of Priority efficacy supplements	Review and act on 90 percent of standard PDUFA efficacy supplements within 10 months; and review and act on 90 percent of priority PDUFA efficacy supplements within 6 months of receipt.	Review and act on 90 percent of standard PDUFA efficacy supplements within 10 months; and review and act on 90 percent of priority PDUFA efficacy supplements within 6 months of receipt.
Biologics Goal 3	Review and act on 90 percent of PDUFA manufacturing supplements within 6 months of receipt, and review and act on 90 percent of PDUFA manufacturing supplements requiring prior approval within 4 months of receipt.	FY 2001: Data available 5/2002 FY 2000: 100 percent of Standard manufacturing supplements and 100 percent of Priority manufacturing supplements	Review and act on 90 percent of PDUFA manufacturing supplements within 6 months of receipt, and review and act on 90 percent of PDUFA manufacturing supplements requiring prior approval within 4 months of receipt.	Review and act on 90 percent of PDUFA manufacturing supplements within 6 months of receipt, and review and act on 90 percent of PDUFA manufacturing supplements requiring prior approval within 4 months of receipt.
Biologics Goal 4	Review and act on 90 percent of Class 1 resubmitted original PDUFA applications within 2 months; and review and act on 90 percent of Class 2 resubmitted original PDUFA applications within 6 months of receipt.	FY 2001: Class 1 — 100 percent Class 2 - Data available 5/2002 FY 2000: Class 1 — 100 percent Class 2 — 100 percent	Review and act on 90 percent of Class 1 resubmitted original PDUFA applications within 2 months; and review and act on 90 percent of Class 2 resubmitted original PDUFA applications within 6 months of receipt.	Review and act on 90 percent of Class 1 resubmitted original PDUFA applications within 2 months; and review and act on 90 percent of Class 2 resubmitted original PDUFA applications within 6 months of receipt.
Biologics Goal 5	Review and act on 90 percent of complete blood bank and source plasma PLA/BLA submissions, and 90 percent of PLA/BLA supplements within 12 months after submission date.	FY 2001: Data available 11/2002 FY 2000: Complete Submissions — 100 percent Supplements — 100 percent	Review and act on 90 percent of complete blood bank and source plasma PLA/BLA submissions, and 90 percent of PLA/BLA supplements within 12 months after submission date.	Review and act on 90 percent of complete blood bank and source plasma PLA/BLA submissions, and 90 percent of PLA/BLA supplements within 12 months after submission date.
Animal Drugs and Feeds Goal 1	Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80 percent.	Completed FY 2001: 80 percent	Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80 percent.	Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80 percent.
Animal Drugs and Feeds Goal 2	Review and act on 75 percent of NADAs/ANADAs within 180 days of receipt.	Not Completed: FY 2001 --50 percent. Review resources were shifted in order to reduce the backlog of pending overdue applications.	Review and act on 50 percent of NADAs/ANADAs within 180 days of receipt.	Review and act on 90 percent of all new animal drug applications and supplements within 275 days and review and act on 90 percent of all investigational new animal drug data submissions (type P) within 325 days.
Animal Drugs and Feeds Goal 3	N/A	N/A	Reduce pending overdue Animal Drug applications by 15 percent.	Reduce pending overdue Animal Drug applications by 15 percent.
Animal Drugs and Feeds Goal 4	Continue to pilot and validate procedures to receive protocol submissions electronically. Initiate the development of a method for receiving protocol submission electronically	Changed focus of protocol submission to hard media (e.g., tapes, cd-rom, hard drives). Implemented automated logging/routing of e-mail electronic submissions. Posted standards on dockets for submission of electronic information in support of NADAs. On-going contract to develop CVM-specific guidance for file organization and format for hard media submissions. Expanded electronic archive to accept hard media submissions.	Pilot and validate the procedure for receiving protocol submissions electronically.	Receive protocols and ADE active form.
Animal Drugs and Feeds Goal 6	Revise and develop 14 guidances. FY 2001: 3 manufacturing, 10 new drug approval process and 1 Veterinary International Conference on Harmonization (VICH) guidances.	FY 2001: Completed 7 final and 7 draft manufacturing, new animal drug approval process and VICH guidances.	FY 2002: NA	FY 2003: NA
Medical Devices Goal 1	Review and Complete 90 percent of Premarket Approval Application (PMA) first actions within 180 days.	Completed FY 2001: 97 percent	Review and Complete 90 percent of Premarket Approval Application (PMA) first actions within 180 days.	Review and Complete 95 percent of Premarket Approval Application (PMA) first actions within 180 days.
Medical Devices Goal 2	Review and complete 90 percent of PMA supplement final actions within 180 days.	Completed FY 2001: 98.4 percent	Review and complete 90 percent of PMA supplement final actions within 180 days.	Review and complete 95 percent of PMA supplement final actions within 180 days.
Medical Devices Goal 3	Review and complete 95 percent of 510(k) (Premarket Notification) first actions within 90 days.	Completed FY 2001: 100 percent	Review and complete 95 percent of 510(k) (Premarket Notification) first actions within 90 days.	Review and complete 95 percent of 510(k) (Premarket Notification) first actions within 90 days.
Medical Devices Goal 5	Complete 95 percent of PMA Determination meetings within 30 days.	Completed FY 2001: 100 percent	Complete 95 percent of PMA "Determination" meetings within 30 days.	Complete 95 percent of PMA "Determination" meetings within 30 days.
Medical Devices Goal 6	Recognize 20 new or enhanced standards to use in application review.	Completed FY 2001: 30 additional standards recognized.	Recognize 20 new or enhanced standards to use in application review.	Recognize 20 new or enhanced standards to use in application review.
Pediatric Medicine
Human Drugs Goal 2	Implement, evaluate, track and report on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule	FY 2001: Written requests issued 43; Exclusivity determinations 19; As of October 2001, over 47,000 children have participated in clinical trials as a result of FDA requested studies under the exclusivity provision. Nine drugs approved and labeled for pediatric use based on studies in response to Written Requests.	Implement, evaluate, track and report on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule.	Implement, evaluate, track and report on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule.
Generic Drugs
Human Drugs Goal 3	Review and act upon 50 percent of fileable original generic drug applications within 6 months after submission date.	FY 2001: Data available 1/2003 FY 2000: 55.6 percent	Review and act upon 65 percent of fileable original generic drug applications within 6 months after submission date.	Review and act upon 75 percent of fileable original generic drug applications within 6 months after submission date.
Human Subject Protection
Human Drugs Goal 4	N/A	FY 2001: 553 inspections completed	Protect human research subjects who participate in drug studies and assess data quality from these studies by conducting approximately 780 onsite inspections and data audits annually.	Protect human research subjects who participate in drug studies and assess the quality of data from these studies by conducting approximately 780 onsite inspections and data audits annually.
Medical Devices Goal 7	Conduct 250 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.)	Not Met: 238 BIMO inspections conducted	Conduct 290 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.)	Conduct 290 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.)