Drug Safety and FDA Reform: Are we better off now?

After numerous reports of safety concerns and several withdrawals of medications from the U.S. market, federal legislation was enacted last year to change the structure and improve the safety oversight of the FDA. The Food and Drug Amendments Act of 2007, or FDAAA, included a number of provisions that address safety concerns throughout a drug's life cycle. The FDAAA mandates that the agency conduct post-marketing surveillance and develops new quantitative tools to assess and manage drug benefits and risks. As part of the implementation process, the FDA is proposing a 5-year safety modernization plan which will include the improvement of these methodologies to maximize public health protections. New public health training programs will be needed, as will efforts to improve drug safety information and communication. Some question whether these efforts can succeed without many more resources, while others are concerned that there remains a conflict in the FDA's roles of approving drugs for marketing and of monitoring drugs for safety. This session will include speakers from the FDA, the pharmaceutical industry and academia who will address the content of the legislation and its implications for patients and the public health community.

Participants:

Update on FDA's Drug Safety Initiatives

Janet Woodcock, MD, Director, Center for Drug evaluation and Research (CDER), FDA or another FDA representative

Industry's View of Drug Safety Reforms

Alan Goldhammer, PhD, Dep. V.P., Regulatory Affairs, Pharmaceutical Research and Manufacturers Association (PhRMA) or another PhRMA representative

Issues and Obstacles in the Communication of Adverse Drug Effects

Beatrice Golomb, MD,PhD Associate Professor of Medicine

University of California, San Diego School of Medicine

Moderator: Stanley A. Edlavitch, PhD, MA

Professor of Epidemiology and Director Graduate Training

UMKC School of Medicine