The FDA, in an effort to bring promising new therapies to patients as quickly as possible, has introduced a spate of shortcuts to speed up the approval process. Those programs are working as intended, new research finds, but drug companies are often loath to fulfill their obligations.
The big idea behind the FDA’s accelerated drug approval program is that regulators will OK a promising drug based on clues that it will improve patient lives, so long as pharma companies later carry out larger trials to confirm those hints of efficacy. But looking at four years of data, a team of researchers found that only 50 percent of those trials actually took place within three years of approval.
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