The U.S. Food and Drug Administration (FDA) is increasingly approving new drugs, according to an analysis conducted by BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry. Forbes, who commissioned BioMedTracker to do the analysis, reports that “new molecular entities”, or drugs that have never been marketed before, were rejected 66 percent of the time as recently as 2008. That rate has increased in recent years. The FDA rejected three new uses and approved 25 this year so far, with an approval rate of 89 percent for NME. This trend raises concerns about approving unsafe drugs, especially in light of new legislation seeking to expedite the process.
These trends are important in light of the 21st Century Cures Act, which seeks to expedite approvals even more and lower the bar for safety and efficacy evidence. While new legislation is eager to make approval easier for drug makers, the risks of doing so should also carefully be considered. Vioxx and Avandia, drugs that resulted in widespread safety concerns, were approved in the midst of a drug approval boom in the 1990s and early 2000s, Forbes, reports.
Forbes reports that the statistics are even more astounding upon closer review, since BioMedTracker and the FDA count NME differently. BioMedTracker considers every use of a new medicine. For instance, the new antibiotic Avycaz was rejected this year to treat hospital-acquired pneumonia but it was approved for two other uses. Similarly, the diabetes drugs Jardiance was rejected for combination treatment with metformin but it approved for use on its own. The true FDA approval rate is about 96 percent when looking at the data in this manner. Omitting BioMedTracker’s counting of multiple uses for one drug means that the FDA rejected only one drug, Merck’s anesthesia antidote Bridion, and approved 23.
Using BiomedTracker’s definitions is helping for comparing the current high approval rate with the past. In 2008, 50 percent of NME were approved by the FDA, according to BioMedTracker. In 2009, this figure fell to 44 percent and rose to 86 percent in 2011. The data shows that the FDA is increasingly giving approval for NME.
The BioMedTracker analysis also considered every time a company asked the FDA for an approval, finding similar trends. One caveat to the data is that rejections are only made public If the drug makers choses to share that information.
The FDA approved 56 precent of approval requests in 2008; out of 134 requests, 75 were approved. This statistics did not change significantly in 2009 and 2010. In 2011, 2012 and 2013 the rate rose to 70 percent. The approval rate rose to 77 percent last year and jumped even more this year, to 88 percent.