An expedited review process gets drugs onto the market sooner, but that doesn’t mean that they are as safe as you want them to be. In a study published in JAMA Internal Medicine, lead researcher Thomas Moore and colleagues question whether or not the fast-track review is worth the risks. The study followed 20 drugs approved in 2008, 8 of them went through some type of expedited review.
Moore, who is also the senior scientist at the Institute for Safe Medication Practices, said that “Development time and approval of new drugs is really quite rapid, especially for the novel drugs, but a large number of safety questions remain unanswered,” When a drug goes through expedited review, it means that the U.S. Food and Drug Administration (FDA) can waive its own rules as it deems necessary. These drugs are approved in about five years, which is about two and a half years sooner than drugs going through standard review.
The study’s authors found that fast-track drugs were tested in an average of 104 patients, while drugs that went through standard review were tested in about 580 patients. Moore took issue with this, commenting that he was “surprised by how limited some of the testing was,” I think that having poorly tested drugs that we don’t know enough about is of very limited benefit to anybody,” he said.
Overall, five drugs ended up having a boxed warning, which is the most serious kind of warning that can be added to packaging. Four other drugs needed additional precautions on their labeling. Moore predicts that this will only get worse as time does, noting that the FDA takes about 11 years to act on a safety issue.
The number of post-marketing studies also raised some concerns. A post marketing study is a study that is ordered when there are still a number of safety issues that need to be a addressed for a drug that is on the market. According to the study, the FDA ordered 48 post-marketing studies for the 8 expedited drugs and 37 studies for the 12 standard review drugs. Even more disconcerting is the observed timelines for these. Overall, the authors found that 14 out of the 48 studies that were supposed to be complete by 2013 were unfinished or did not submit for review on time; timelines for six drugs could not be found altogether.