U.S. Food and Drug Administration
Performance Plan
2002

Desired Outcome

To ensure that domestic manufacturers produce safe medical products.

Key Performance Goal

Why is FDA's contribution important?

FDA is responsible for ensuring the safety of medical products produced by all domestic medical product establishments. These comprise a wide array of products that have become medically and technologically more complex. They can pose great risks if not designed and manufactured properly.

Congress and the American People expect FDA to inspect medical product manufacturers on a regular basis, for compliance with high product quality and safety standards.

Although a direct causal and quantitatively defined relationship between inspections and desired public health outcomes cannot be established with certainty, it is reasonable to assume that regular inspections are more likely to reveal problems that require correction. The Agency uses its statutory inspectional authority, to provide this assurance. This was the wisdom and rationale behind the law requiring FDA to conduct inspections at specified maximum time intervals, such as once every two years. The Agency's ability to identify and remove unacceptable medical products from the marketplace is closely related to the level of inspections it is able to conduct.

How are we going to do this?

FDA continues to make the most effective use of limited inspection resources by implementing four key strategies:

• Leveraging through contracts with the states, other third parties and outreach to small firms;
• Focusing resources on the highest risk firms and medical products - areas which will bring the greatest benefit to health;
• Ensuring that inspectors have the scientific and technological support necessary to make quick and valid judgements about medical device compliance; and
• Reengineering the inspection process by implementing quality system inspections that will significantly reduce inspection time and increase effectiveness.

Based on experience, a significant investment in training and time is necessary to ensure quality uniform inspections.

Consequences of Not Achieving the Goal

Long delays in visiting firms will increase the potential for unsafe medical products to present themselves to the American Public. In FY 2000, FDA was alerted by local hospitals of what proved to be contaminated iodine surgical swabs. The firm that had produced the swabs had not been inspected for seven years resulting in estimates the 200,000 people had been infected. Earlier detection could have prevented and corrected the problem.

FDA's inspection force is attempting to monitor a regulated industry in an environment that has changed rapidly and become significantly more complex over the past several years. Contributing to this change have been much more technologically complex and diverse products both domestically and internationally and increasing use of the internet by industry to develop, produce, distribute and market their products.

How Are We Doing?

The law requires that FDA inspect certain biologics, human and animal drug, and medical device manufacturers at least once every 2 years. In recent years, coverage has fallen short of meeting these statutory requirements. Although at least 50 percent of statutory establishments should be inspected annually, only 22 percent of human drug, 39 percent of animal drug, and 13 percent of medical device statutory establishments were inspected in FY 2000. The Agency did inspect 57 percent of the biologics statutory establishments in FY 2000.

Previous | Table of Contents | Next