When the FDA puts drugs on the fast track for approval, they do make it to market sooner. But they're tested for a shorter period of time than are drugs reviewed under the agency's standard process, according to a new study in the Journal of the American Medical Association. And that has researchers worried.
The study may seem to be stating the obvious--of course faster approval means less time in testing. In responding to the article, the FDA said it's looking at the study in more detail, but on first glance, "it shows that [expedited development is] working as intended by getting promising new drugs to patients more quickly."
But the fast-tracked drugs are approved conditionally. Companies are required to continue studying the products, particularly with an eye to safety signals. The JAMA study found, however, that those studies have gone undone, uncompleted or unreported. That means key information on these new products remains missing.
The JAMA research looked at new drugs approved in 2008. Of those 20 products, 8 went through the FDA's expedited review program; they underwent a median of 5.1 years of clinical testing before approval, compared with 7.5 years for the rest of the meds approved that year. "The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrower patient population with extensive additional testing conducted after approval," the study noted.
At least theoretically. For the drugs included in the JAMA study, the FDA required 85 follow-up trials to check for safety. Only 40% of them had been completed by 2013, the authors found. In an accompanying editorial, Harvard University professor Daniel Carpenter wrote that the FDA hasn't done enough to make sure drugs approved based on testing in limited patient populations are only marketed in those populations. "The current system of accelerating drug approval in the United States can be described as a growing hodgepodge of exceptions to the rule of rigorous premarket review," Carpenter wrote (as quoted by Reuters).
The FDA says it is balancing preapproval and postapproval study to answer demands for faster access to lifesaving treatments. In serious and life-threatening diseases, the FDA told Reuters, "patients and physicians who treat them have told us repeatedly that they are willing to accept greater uncertainty about risk in order to have access to the hope of improved treatment today. … We believe we have set the bar for the balance … in the right place."
Special Report: FDA Approvals of 2012