Performance Improvement 2001. Food and Drug Administration (FDA)


MISSION: To protect and promote public health through food, drug, medical device, and cosmetic regulation.

Evaluation Program

The Food and Drug Administration’s FY 2000 Evaluation Program ultimately reflected some of the 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 its efforts in that environment, which grows increasingly complex and more institutionally networked. The Agency will strive to maintain the scientific knowledge base 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 2000 Performance Report, are one indication of how well FDA is meeting its goal of making timely pre-market review decisions. The focus of performance goals under PDUFA 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. For example, FDAMA has afforded FDA greater flexibility in the scope and amount of data collected and reported on medical devices than was possible under the previous mandate. The Agency has reevaluated the requirements already in place, 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 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 Leveraging, another element of FDA’s strategic framework, represents a significant shift in FDA’s direction for the twenty-first century as the Agency works to leverage a more technologically complex environment. One strategy involves 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 illustrated one of the initiatives in this area. Prior to the court decision that ended this program, FDA planned to reduce access to tobacco products by youths under 18 through new FDA requirements for retailers.