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Castles of Sand II: How should the FDA weigh timely drug access with consumer safety?

The U.S. Food and Drug Administration
The U.S. Food and Drug Administration
The U.S. Food and Drug Administration/Flickr

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The U.S. Food and Drug Administration (FDA) began making deals with drug companies in the early 1990s: in exchange for green-lighting their cancer drugs based only on preliminary evidence, the companies would conduct follow-up studies to ensure those early results. But many of the companies failed to conduct those studies. At the same time, new studies show the FDA’s 510 (k) system, an accelerated approval process, saves time and money but also accounts for the majority of product recalls. How rigorous is the FDA when it comes to approving new drugs and new medical devices? Depends who you ask—some say the process needs to be streamlined to provide patients fast access to new drugs and devices; others caution that the process needs to be slowed down until full data can be compiled; critics on both ends of the spectrum agree the process needs to be made more transparent and consistent across the board. How should the FDA weigh providing quick access to new drugs against endangering the public’s health? And for drugs and devices that have been recalled after being approved – where’s the glitch? Is the FDA too fast, too slow, or just right?


Diana Zuckerman, President of the National Research Center for Women & Families as well as the Cancer Prevention and Treatment Fund; authored recent study on the recall of medical devices that appeared in the journal Archives of Internal Medicine

David Nexon, Senior Executive Vice President of the Advanced Medical Technology Association (AdvaMed), a medical device trade association; served for more than 20 years as the Democratic Health Policy Staff Director for the Senate's Health, Education, Labor and Pensions Committee; served as the Senior Health Policy Advisor to the late Senator Edward Kennedy (D-MA)

Scott Gottlieb, M.D., a practicing physician; served in various capacities at the Food and Drug Administration, including senior adviser for medical technology, director of medical policy development, and, most recently, deputy commissioner for medical and scientific affairs.