Dr. David Kessler was Commissioner of the Food and Drug Administration from 1990-1997, originally appointed by the first President Bush and re-appointed by President Bill Clinton. To be appointed by two presidents of different parties is no small feat in this town.
But his tenure at FDA was notable for much more than that. When he departed the FDA, the Baltimore Sun wrote that "Dr. David Kessler departs after six years as head of the Food and Drug Administration with an enviable record of accomplishment. When he arrived at the agency, it was widely regarded as a paper tiger, a bureaucracy weighed down by lethargy and red tape. No one can say that now."
Much has changed since then. The agency was rocked during the 2000s and public confidence shaken. In addition, medicine has changed significantly and the the agency has been handed expanded authorities, including the regulation of the marketing of tobacco products. There may be expanded food authority as well should the Food Safety Modernization Act pass Congress.
I recently had the opportunity to sit with Dr. Kessler and talk about some of the current challenges that he sees in today's regulatory environment. In this, the first of a four part interview, I asked him about the expanded authorities of the FDA since his tenure. And the bottom line with all of this change and expansion – how can the FDA do all that is being demanded of it and do it well?