Reforming the FDA's Drug Approval Process

Host: Jack Lewin, MD Guest: Mark McClellan, MD, PhD It takes a substantial measure of time, money and manpower to bring a new drug from the bench to the marketplace. One key aspect of this sequence is the drug approval process, overseen by the Food and Drug Administration (FDA). Host Dr. Jack Lewin welcomes Dr. Mark McClellan, director of the Engelberg Center for Health Care Reform at the Brookings Institution, former commissioner of the FDA and administrator of the Centers for Medicare and Medicaid Services, to discuss a range of issues within the FDA's approval process: from essential boosts in funding, to more transparency about conflicts of interest, to the imperative need for comprehensive, real-time surveillance of long-term drug outcomes, how can the agency devote more attention to each of these areas of concern?