'During my years w/ the FDA, I learned that the available data on a new drug are seldom as complete and unequivocal as you might like. But getting drugs to patients can be a matter of life or death, so you need to make hard decisions.' -Dr. Henry Miller
During my years as a Food and Drug Administration official, I learned that the available data on a new drug are seldom as complete and unequivocal as you might like. But getting drugs to patients can be a matter of life or death, so you need to make hard decisions. Fortunately, the regulations offer some flexibility so that the criteria for demonstrating efficacy are more lenient in certain critical situations. One of those pathways is called “accelerated approval.
The drug’s sponsor is then required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug provides an actual clinical benefit, then the FDA grants full or traditional approval for the drug. If the confirmatory trial fails to show that the drug provides clinical benefit, in theory the FDA has regulatory procedures in place that could lead to removing the drug from the market.
Third, if the confirmatory studies fail, the companies sometimes resist having the accelerated approval withdrawn even if the “confirmatory” studies show that the drug doesn’t work.
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