MISSION: To protect and promote public health through food, drug, medical device, and cosmetic regulation.
FDA Evaluation Program
Systematic changes in the government management environment are strongly influencing the setting, conduct, and use of evaluation activities in FDA. Three forces--all related to the goals of the Government Performance and Results Act--are reshaping the evaluation function within FDA.
The reorientation of all government managers toward performance management has shifted the responsibility for program evaluation from specialized staff offices and contractor studies to the day- to-day line managers. Picking appropriate program goals, establishing a valid measure for those goals, and collecting management information to record the measured progress toward the goals are now integral parts of the new government manager's responsibility. Relearning the role of management regarding these shifted responsibilities is a key priority.
Most of FDA's management performance measures are the same as those for regulated industries. Thus, although the beneficiary of FDA's performance is ultimately the general public, FDA operates in a manner that supplies industry with an essential component of commercial success. FDA's approval of a new drug, for example, not only satisfies a legal requirement but also assures the public of the safety and efficacy of the drug. Collaboration between FDA and its regulated customers regarding the design and coordination of the joint responsibilities to ensure effective high-quality products was a revolutionary concept, but it is becoming the new norm under the customer-conscious GPRA directives.
Increasing Rigor of the Rulemaking Process
FDA establishes standards of safety and efficacy through rules published in the Federal Register. Many safety and efficacy standards are also performance standards that industry is obliged to meet. Examples are the Good Manufacturing Practices regulations. Today, virtually every FDA final rule of significant magnitude includes elements found in classic program evaluations- -a critique of the existing system, alternatives for better performance, performance and cost tradeoffs, reactions and suggestions of customers, and conclusions with an action timetable for implementation. The new directives of the Administration as well as the possible legislative action by Congress will bring the rulemaking process of the future even closer to the classic evaluation process.
In summary, FDA's evaluation efforts are driven by the mandates of GPRA and its corollaries; are carried out by line managers rather than specialized evaluation staffs; and are focused on performance management, customer participation, and rigorous rulemaking. Because it receives its funds from the U.S. Department of Agriculture's appropriations rather than Public Health appropriations, FDA does not conduct evaluations under the 1 percent evaluation set-aside authority.
Summary of Fiscal 1995 FDA Evaluations
The past year was the second year under the new evaluation paradigm. The following examples illustrate the manner in which managers have integrated evaluation into their line responsibilities and have conducted evaluation in cooperation with the affected customer.
"Implementation of the Prescription Drug User Fee Act." In fiscal 1995, FDA's drug and biologic review processes involving more than 1,000 Field Test Evaluations (FTEs) completed their third full year of successful performance management toward goals and performance measures jointly established by FDA managers and industry customers. The goals were ambitious. Line managers agreed to clear an overdue backlog equivalent to half a year of submissions, review a pending workload equal to nearly 2 years of submissions, and build a review capacity that could meet a phased schedule of substantially accelerated review goals. FDA managers met or exceeded all of the performance goals for the year.
"Assessment of the Mammography Quality Standards Act of 1992 (MQSA)." This program is FDA's second major user-fee, performance-oriented, GPRA-style initiative. MQSA requires facilities that perform mammography services to be certified as meeting standards developed by FDA. FDA managers want to ensure that as MQSA is implemented, patients can maintain access to quality services, especially patients in areas that are short of health professionals. To achieve this goal, FDA managers contracted for a cost-benefit analysis of the program. The contractor reviewed records from more than 10,000 facilities that had applied for accreditation and from more than 500 that had ceased operations. The contractor presented the results of the cost-benefit analysis to FDA managers who then used them to develop a performance-oriented regulatory policy coordinated with participating customers.
FDA Evaluations in Progress
The evaluation agenda of line managers in fiscal 1996 will be influenced by the objectives discussed below, which merely reflect the forces shaping their evaluation role.
Managers of all FDA programs are evaluating their performance measures in light of GPRA standards. Broad-based training of managers to enable them to implement the performance design of their responsibilities is under way. This multiyear process toward a new standard of performance measure will end its first phase with the formulation of FDA's 1997 budget.
FDA managers are identifying further opportunities to involve their customers in the design and testing of alternative ways of doing business. The design and implementation of the Prescription Drug User Fee Act (PDUFA) is the most notable example of the successful pursuit of this objective. Initiatives with import brokers to facilitate the entry of safe products into the country is another example. Managers plan to involve customers in the redesign of several establishment inspection functions.
FDA managers are adding a new customer-sensitive dimension to their increasingly rigorous rulemaking function by implementing the President's directive to promote negotiated, consensual rulemaking. This is a marriage of customer participation and rigorous rulemaking that is attracting serious attention by FDA managers.
One example of the evaluation projects managers will undertake in fiscal 1996 to implement the stated objectives is the Fourth Annual Evaluation of PDUFA. Fiscal 1996 is a critical year for implementing PDUFA. Negotiations on its renewal will begin shortly thereafter. FDA managers will use performance data from this GPRA-style program to convince customers and Congress of the merits of continuing the program.
New Directions for FDA Evaluation
Changes in government management have created a systemic change in FDA's evaluation function. The new paradigm driven by line managers' performance responsibilities, by the imperatives for involving customers, and by directives for analytically rigorous rulemaking has replaced the traditional practice of evaluation guided and managed by centralized, specialized evaluation staffs.