Mission Critical 3462

Originally Published MX September/October 2003

COVER STORY

FDA Commissioner Mark B. McClellan looks at national healthcare policy and his agency's pivotal role in promoting medtech innovation.

Interview by Steve Halasey

During his first 10 months at FDA, Commissioner Mark B. McClellan, MD, PhD, has covered a lot of ground. Moving adeptly among the industries regulated by the agency, McClellan has launched fundamental policy changes in such varied areas as prescription drug labeling, the availability of generic drugs, fraudulent claims about dietary supplements, direct-to-consumer advertising, the monitoring of adverse events involving medical devices and prescribed medications, and the security of the nation's food supply.

Most important for medtech executives, McClellan has also directed FDA to undertake a multifaceted medical technology initiative that seeks to significantly improve and expedite the agency's regulatory processes—including its review of premarket submissions.