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To the Editor: In their Commentary, Drs Psaty and Charo¹ discuss how the Food and Drug Administration (FDA) has responded "in part" to the recommendations by the Institute of Medicine (IOM) on drug safety. In Table 2, they list 25 specific IOM recommendations alongside the FDA's responses. Item 4.12 stands out as the only item to which the FDA responded "not accepted." That item recommended that the FDA post all New Drug Application (NDA) review packages on the FDA's Web site, a suggestion that has been made in the past.² The FDA response reads "Since 1998, FDA has committed to post all new NDA and BLA [biologics license application] original approval packages, but has not had sufficient resources to post all supplement reviews."³

Food and Drug Administration reviewers create the primary review documents in Microsoft Word format and convert them to a portable document format (PDF). The PDF circulates electronically . . . [Full Text of this Article]

Erick H. Turner, MD
turnere@ohsu.edu
Mental Health & Neurosciences Division
Portland Veterans Affairs Medical Center
Portland, Oregon

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FDA Responds to Institute of Medicine Drug Safety Recommendations—In Part
Bruce M. Psaty and R. Alta Charo
JAMA. 2007;297(17):1917-1920.
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