During fall 1997, legislators, lobbyists, and regulators celebrated a legislative truce in the decades-old battle over Food and Drug Administration (FDA) reform. With a notable display of unanimity, Congress passed and the President signed the Food and Drug Administration Modernization Act of 1997 (FDAMA), 1 a bill hailed as a remarkable compromise between ardent protectors of public health and equally outspoken advocates for this country's pharmaceutical, medical device, and biotechnology industries. 2 The FDAMA is pragmatic in tenor; rather than dismantling FDA or privatizing many of the agency's functions (two proposals advanced during the contentious reform debates3) the new law preserves much of FDA's regulatory structure, while aiming to streamline approval processes and enhance communication between industry and regulators.