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FDA Moves Cancer Cures into the Slow Lane
Dr. Scott Gottlieb, Forbes, 1-18-05

Gottlieb says that there is a “dangerous backlash” inside the FDA, “with rank-and-file medical reviewers taking an increasingly cautious approach to the approval of important new medicines.” Worse yet, the Oncology Drug Advisory Committee is becoming more cautious and may be “[clamping] down on the number of cancer drugs qualifying for accelerated approval.”

More stringent standards for accelerated approval “could add years to the development of new cancer drugs, and require more of them to undergo all three phases of clinical trials, rather than letting the most promising new drugs that target unmet medical needs onto the market after only two rounds of clinical study, as is now customary.”

This could be very bad news for medical innovation, if investors in biotech companies conclude that the enormous resources required to shepherd new drugs through development and FDA approval could be better spent elsewhere.

Gottlieb concludes that the FDA’s new go-slow approach might keep it out of the news cycle or safe from Congressional criticism – but it will inevitably hurt cancer patients desperate for new treatments.

Project FDA.
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