The Food and Drug Administration's FY 1998 Evaluation Program ultimately reflects the four broad goals established and promulgated by the Department of Health and Human Services (HHS) for which FDA has responsibility. HHS's goals are products of its strategic performance planning process, and FDA uses its own strategic framework to accomplish these goals. This process also satisfies the implementation requirements of the Government Performance and Results Act (GPRA) and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The strategic and performance process is an evolving set of program directions for FDA as changes occur in FDA's dynamic environment. FDA's challenges, now and in the future, will rest on its ability to leverage that environment, which will grow increasingly complex and become more institutionally networked. The Agency will strive to develop and maintain the scientific integrity necessary to achieve greater effectiveness in assuring the quality and availability of the products it regulates.
One goal area within FDA's strategic framework is Pre-Market Review, where the objective is to make timely and cost-effective pre-market review decisions, while assuring product safety and efficacy. The results achieved and reported in the Prescription Drug User Fee Act (PDUFA) FY 1998 Performance Report, are one indication of how well FDA is meeting its goal of making timely pre-market review decisions. FDA exceeded all of the performance goals specified under the Prescription Drug User Fee Act. FDAMA continues the progression toward quicker review times initiated under the Prescription Drug User Fee Act of 1992, extending into the investigative phase of drug development with a series of new goals that will take effect in FY 1999. The objective of the FDAMA goals is to expedite the entire drug development and review process, from research to approval, without compromising the safety or the quality expected from the Agency's application review process.
Another goal area within FDA's strategic framework is Internal Capacity, which focuses onFDA's ability to make effective pre- and post-market regulatory decisions. One strategy for accomplishing this goal is through the implementation of decision-supportive information systems where reporting burdens are being reduced for the regulated industry. FDAMA is affording FDA greater flexibility in the scope and amount of data collected and reported on medical devices than was possible under the previous mandate. It has removed the mandatory requirements for post-market surveillance and tracking, thereby enabling the Agency to redirect resources to more significant health concerns. The Agency has reevaluated those requirements already in place, while removing those that no longer made sense from a public health perspective. As a result, hundreds of device tracking and post-market surveillance orders were rescinded for more than a dozen product types. FDAMA has also enabled FDA to modify its user-facility reporting program for medical devices from a mandated universe of facilities to a representative sample of facilities.
External Leverage, another element of FDA's strategic framework, reflects the ability of external stakeholders to manage FDA-regulated risk. This goal represents a significant shift in FDA's direction for the twenty-first century, as the Agency will attempt to leverage a more technologically complex environment. One strategy used to accomplish this goal is fostering industry quality assurance programs, thereby capitalizing on the quality and safety control capabilities already resident in the regulated industry. HACCP (Hazard Analysis Critical Control Point) programs and the implementation of the Mammography Quality Standards Act (MQSA) are two examples of this approach that are underway.
The fourth and final goal area within FDA's strategic framework is Post-Market Assurance, a goal that strives to strengthen the assurance that products on the market, or about to enter the market, are safe. One strategy of accomplishing this goal is by targeting high-risk products. The Tobacco Program illustrates one of the initiatives in this area. FDA plans to reduce access to tobacco products by youths under 18 through new FDA requirements for retailers.