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Commentary

Accelerate drug approval
Robert Goldberg, Ph.D., Washington Times, 6-14-05

Goldberg, also a Manhattan Institute senior fellow, takes issue U.S. Rep. Edward Markey's criticism of a vital FDA program. Markey claimed that the FDA's accelerated approval process for life-threatening diseases is "broken" because, he said, companies marketing these drugs have completed only 50 percent of the studies they were required to complete. Goldberg responds that:

Mr. Markey uses fuzzy math to conclude that 50 percent of follow-up studies have not been completed. Actually, only 4 percent of the nearly 80 studies for drugs that have received accelerated approval are delayed, though they do take longer than anticipated in many cases.

[This is because] once breakthroughs for life-threatening diseases are on the market, it is hard to get patients to enroll in formal studies. As former FDA official Scott Gottlieb notes... "dying patients are unwilling to roll the dice on a placebo controlled trial taking a chance they may get little more than a sugar pill when the drugs are readily available on the market."...



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