Monday, February 12, 1996
By Steve Usdin
WASHINGTON - Fourteen biotech CEOs met last week with FDA Commissioner David Kessler to discuss proposals for speeding early-stage drug development, providing some optimism that the door to administrative reform remains open at the agency.
Meanwhile, House Commerce Committee Chairman Thomas Bliley announced dates for hearings on the agency and suggested that the House Republican leadership finally will introduce reform legislation soon.
The biotech summit with Kessler focused on exploring ways FDA can speed early-stage drug development, Biotechnology Industry Organization President Carl Feldbaum said. In contrast to most of the reforms announced to date, which focus on the final stage of the approvals process and manufacturing and distribution of approved products, the changes under discussion would benefit emerging companies.
The executives came into the meeting with seven or eight specific ideas and the meeting focused on the "nuts-and-bolts" of how FDA can reduce delays at the front end of the drug development process.