Former FDA Commissioners David A. Kessler and Mark B. McClellan discuss Public Policy Implications of the FDA Revitalization Act (FDARA). Dr. James Thurber moderates the discussion.
Mr. Kessler and Mr. McClellan discuss the policy implications of the FDARA and enhancement of America's prescription drug safety systems. The event is part of American University's Drug Safety Forum A Dialogue on Prescription Drug Safety: Seeking Common Ground. The forum explores implications of new legislation to strengthen The Food & Drug Administration and bolster drug safety.
The forum is the first event in a series titled A Dialogue on Prescription Drug Safety: Seeking Common Ground. This program brings together a diverse array of policymakers, health experts, patient advocates, and industry leaders to discuss prescription drug safety and identify common ground policies to protect the health and safety of consumers. The program is supported by Pfizer Inc.
David A. Kessler
David A. Kessler, M.D., is the Dean of the School of Medicine and the Vice Chancellor for Medical Affairs at the University of California, San Francisco. Prior to this appointment, Dr. Kessler served for six years as the Dean of the Yale University School of Medicine.
Dr. Kessler, who served as Commissioner of the Food and Drug Administration from November 1990 until March 1997, was appointed by President George H. W. Bush and reappointed by President Clinton. As Commissioner of the FDA, he acted to speed approval of new drugs and placed high priority on getting promising therapies for serious and life-threatening diseases to patients as quickly as possible. He introduced changes in the device approval process to make it more efficient and ensure that it meets high standards.
Under his direction, the FDA announced a number of new programs, including: user fees for drugs and biologics; the regulation of the marketing and sale of tobacco products to children; and preventive controls to improve food safety.
Mark B. McClellan
In July 2007, Dr. Mark B. McClellan, Senior Fellow, became the Director of the Engelberg Center for Healthcare Reform at the Brookings Institution. In addition, Dr. McClellan is the Leonard D. Schaeffer Chair in Health Policy Studies. Dr. McClellan previously served as Commissioner of the Food and Drug Administration (2002-2004) and Administrator for the Centers for Medicare and Medicaid Services (2004-2006). He also served as a member of the Presidentâ€™s Council of Economic Advisers and senior director for health care policy at the White House (2001â€“2002). In these positions, he developed and implemented major reforms in health policy, including the development of the FDAâ€™s Critical Path initiative, regulatory reforms to modernize pharmaceutical manufacturing and efficient risk-management methods to better address safety issues.
James A. Thurber
James A. Thurber is Distinguished Professor of Government and Director of the Center for Congressional and Presidential Studies. Dr. Thurber has been on the faculty at American University since 1974 and was honored as the University Scholar/Teacher of the Year in 1996. He is author and co-author of numerous books and more than seventy-five articles and chapters on Congress, congressional-presidential relations, congressional budgeting, congressional reform, interest groups and lobbying, and campaigns and elections. Dr. Thurber is a Fellow of the National Academy of Public Administration.
Prescription drug abuse is the fastest growing drug problem in the United States. Although there has been a significant decline in the use of some illegal narcotics such as cocaine, reports from the National Survey on Drug Use and Health (NSDUH) put forth that almost one-third of individuals 12 years of age and older who took drugs for the first time in 2009, started by abusing prescription drugs. Data also suggests that over 70 percent of individuals who took prescription painkillers got them from family or friends, while approximately 5 percent got them from a "black market" source, such as a drug dealer or from foreign online pharmacies.
Furthermore, a recent Monitoring The Future study (America's biggest survey of drug usage within the younger population) showed that prescription pills are the most abused type of drugs second to marijuana. This problem is not limited only to civilians. Non-prescribed drug use in the military has went up from 4 percent to 11 percent among those in active duty over a period of 3 years from 2005 to 2008, mostly due to pharmaceutical drug abuse.
Although different classes of pharmaceuticals are taken without a prescription, the largest growing and most harmful probelm involves opiates. The number of opiate-based drugs dispensed for pain relief has spiked in recent years. In 2000, retail pharmacies filled 174 million prescriptions for opiates; a decade later, prescriptions increased by almost 50 percent to 257 million. Another alarming report is that opioid overdoses, usually attributed to heroin, are now due more frequently to abuse of prescription pain relief meds.
Rehab programs specializing in painkiller addiction have become more important in helping turn this tide, enabling those afflicted to break the cycle of addiction and start living a happy, meaningful life without the use of opioids. Ideally, the best rehab is a place where people can speak openly and truthfully regarding their drug addiction for the 1st time and without fear of being persecuted or labeled negatively.