Tomas J. Philipson of the University of Chicago and four colleagues analyzed the economic and human effects of the first decade of the user-fee system. They estimated that speedier approvals yielded at least $11 billion in new profits for the industry - an average of about $39 million for each new drug. Faster action also saved 180,000 to 310,000 years of life for patients - a gain partially offset by up to 56,000 years lost to the harmful effects of drugs approved but later withdrawn for safety reasons.
The FDA touts the consumer payoff. "Early access to safe and effective medicine is good for public health," Theresa Mullin, FDA assistant commissioner for planning, tells the Post. "For people with Parkinson's, with early Alzheimer's, with cancer, time is a luxury you just don't have."
Then, there's the finding by Daniel Carpenter, a government professor at Harvard, who has studied the potential effects of the time pressure that the PDUFA placed on the agency. He found that drugs approved in the two months before the review deadlines were three to five times as likely to be taken off the market for safety reasons as drugs approved earlier in the cycle or after, when the agency missed the deadline, the paper writes.
"Our analyses suggest the (act's) clocks have dramatically changed the behavioral structure of the FDA review cycle," he wrote.
The bottom line: money changes everything.