Kessler Sums Up FDA Achievements

WASHINGTON, D.C.: In his final major speech in office, outgoing FDA head David Kessler took on his most persistent critics, the U.S. Congress, over the efficiency of his organization in approving new drugs and medical devices. Kessler noted that since his arrival six years ago, the time the FDA takes to review and approve new drugs has been cut in half to fifteen months. In 1996, the agency approved a record 46 completely new chemicals for medical use. Kessler disputed claims that the European Union drug-approval bureaucracy is more efficient. Of the fifteen drugs that were okayed by both agencies last year, Kessler said the FDA took half as long and approved 11 of them first. Approval of breakthrough medical devices -- from home AIDS test kits to medical lasers -- has also accelerated, but Kessler admitted there was still room for improvement in that process.