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FDA plans praised, criticized

AAMC says that return on research investment should not be measured only by drug approvals

Paula Park(paulapark52@hotmail.com)

The Food and Drug Administration's (FDA) proposal to reform the drug development process have been met with criticism from the Association of American Medical Colleges (AAMC), but with praise from other groups, including the Pharmaceutical Research and Manufacturers Association (PhRMA).

The AAMC charges that the FDA plans begin with a faulty premise: that the federal biomedical investment should translate directly to new treatments. David Korn, senior vice president of Biomedical and Health Science Research at AAMC, also warned that any attempt to involve the National Institutes of Health (NIH) in drug-related research could dilute funding for "curiosity driven" investigations that have, in the end, contributed to new therapies.

"The vast majority of NIH money is in fundamental research, not product development," Korn told The Scientist. "To equate the success of the NIH investment to whether there are 25, 40, or 60 products [submitted to] the FDA is misleading. It's...

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