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Commentary

Opening Pandora's Pillbox
Dr. Scott Gottlieb, Health Affairs, 7-1-05

As the FDA faces mounting criticism for perceived lapses in postmarket drug safety, Scott Gottlieb—formerly the FDA’s Director of Medical Policy Development—offers some practical and effective ways to reform the system.

The FDA has already taken some steps to create more active and proactive [postmarket] surveillance tools. With improved resources for conducting this kind of surveillance, as well as resources for undertaking large simple safety studies in collaboration with health care networks on newly approved products, the FDA can improve its safety-monitoring program without burdening its drug approval process. Most importantly, by partnering with health care providers, institutions, product developers, as well as other government agencies, the FDA will more quickly and thoroughly identify and understand the risks associated the products it regulates.


Project FDA.
  
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