Fostering innovation, advancing patient safety: the kidney health initiative

Abstract

To respond to the serious and underrecognized epidemic of kidney disease in the United States, the US Food and Drug Administration and the American Society of Nephrology have founded the Kidney Health Initiative-a public-private partnership designed to create a collaborative environment in which the US Food and Drug Administration and the greater kidney community can interact to optimize the evaluation of drugs, devices, biologics, and food products. The Kidney Health Initiative will bring together all the necessary stakeholders, including patients, regulators, industry, health care providers, academics, and other governmental agencies, to improve patient safety and foster innovation. This initiative is intended to enable the kidney community as a whole to provide the right drug, device, or biologic for administration to the right patient at the right time by fostering partnerships that will facilitate development and delivery of those products and addressing challenges that currently impede these goals.

Figure 1.

Number of randomized controlled trials published in nephrology and 12 other specialties of internal medicine from 1966 to 2010. Reprinted from reference , with permission.

Figure 2.

Stakeholders participating in the Kidney Health Initiative.

Figure 3.

A partial organizational chart of the US Food and Drug Administration highlighting the relationship of the various centers with the Office of the Commissioner and one another.

Figure 4.

Organizational chart of the Office of New Drugs of the Center for Drug Evaluation and Research.

Figure 5.

Project submission and execution process.