Kessler was asked to retain his position by the Clinton administration in February. He took the reins of the agency in December 1990, and at that time announced he would engage in major reorganizing efforts to revitalize and reinvigorate the agency. Previously, FDA had been criticized for its slow enforcement of laws and regulations. But whether or not those efforts, which included appointing new section heads and reorganizing major departments, are perceived as successful depends on one's industry segment, says John Villforth, director of the Food and Drug Law Institute, a nonprofit organization based in Washington, D.C., that monitors FDA.
According to Villforth, the passage of user-fee legislation in the 102nd Congress, with the strong support of Kessler, is giving these industries hope that in the future, FDA approval times will considerably lessen. User fees amount to a payment of $100,000 this year, increasing to $233,000 in five years, to ...
