GPhA Commends FDA Commissioner's Leadership

APRIL 01, 2004

The Generic Pharmaceutical Association (GPhA) recently gave high marks to Mark McClellan, MD, PhD, for his leadership of the FDA. GPhA's head vowed to continue to work closely with him on critical health care cost issues when he heads the Centers for Medicare and Medicaid Services (CMS).

Commenting on Dr. McClellan's appointment to CMS on February 23, 2004, Kathleen Jaeger, GPhA president and chief executive officer, said, "Throughout his brief tenure with [the] FDA, we have found Dr. McClellan to be knowledgeable, thoughtful, pragmatic, and fair. On all of the issues we have worked with him, Dr. McClellan has kept the best interests of the nation's public health at the forefront of his decision making."

She further stated, "In his new role at CMS, Dr. McClellan will have stewardship over a system that must now confront the challenges of cost containment. Our industry, and our member companies, stand ready to work with him, as we did with [the] FDA, when he assumes his new responsibilities."

Jaeger noted that during Dr. McClellan's time with the FDA a number of activities were initiated to remove obstacles to the timely approval of generic medicines, and to strengthen the scientific and regulatory processes associated with generic-drug approval and manufacturing. "As an economist and physician, he is sensitive to both the medical and economic impact of issues related to health care, and has been highly supportive of efforts to ensure that consumers have timely access to more affordable generic medicines."



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