Originally Published MX September/October 2003

COVER STORY

Commissioner McClellan has spent much of 2003 promoting FDA's wide-ranging strategic action plan, but recent criticism of the agency's performance may cause him to take a significantly different tack in future speeches.

In June, congressional critics leveled questions about the agency's failure to keep counterfeit drugs from entering the United States. And at the end of that month, an article in the New York Times questioned "Who's Minding the Drugstore?" and charged that FDA has neglected its enforcement responsibilities under the Bush administration.

In response, McClellan issued a white paper titled Protecting the Public Health: FDA Pursues an Aggressive Enforcement Strategy, which sought to demonstrate that "dramatically increased enforcement" was resulting in "unprecedented success." And at the beginning of August, he devoted a significant portion of his speech before the National Press Club (Washington, DC) to explaining how the agency's current approach to enforcement is linked to the strategic action plan announced earlier in the year. Following is an excerpt from that speech.