Third FDA Report Card Shows Longer Delays for New Drugs in Fiscal Year 1997
EXECUTIVE SUMMARY Click here for the Full Report (Word Document format)
Using data from the federal Food and Drug Administration (FDA), this study examines the agency’s main areas of responsibility for approving new health products for the third consecutive year. Among this study’s findings are:
Congress should take steps to ensure the public fully understands the cost of FDA delays. These include reforms that would require the FDA to self-report on its performance in meeting the Food, Drug, and Cosmetic Act’s deadlines, as well as its performance vis-a-vis foreign regulatory agencies. Most importantly, with every product approved by the FDA, Congress should require the agency to estimate the human cost suffered during the time the agency took to make up its mind.
Click here for the Full Report (Word Document format)
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