Data shows that the U.S. Food and Drug Administration (FDA) is approving most drugs that come their way. BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry, was commissioned by Forbes to conduct a new analysis of FDA drug approval rates. That analysis showed that “new molecular entities”, or drugs that have never been marketed before, were rejected 66 percent of the time as recently as 2008. This year, the FDA has approved 89 percent of NME so far; the agency rejected three new uses and approved 25. The increasingly high approval rates raise concerns about allowing unsafe drugs onto the market.
According to Forbes, the statistics are even more dramatic upon closer review. BioMedTracker and the FDA count NME differently, with the former taking every use of a new medicine into consideration. 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. When taking these situations into account, Forbes reports, the true FDA approval rate it about 96 percent. Omitting BioMedTrackers counting of multiple uses for one drug means that the FDA rejected only one drug, Merck’s anesthesia antidote Bridion, and approved 23.
Considering BiomedTracker’s definitions, however, is useful for comparing the high approval rate with the past. The FDA approval rate was 50 percent in 2008, according to BioMedTracker. This figure fell to 44 percent the next year and increased to 86 percent in 2011. The data indicates that the FDA is increasingly giving approval for NME.
Additionally, BioMedTracker also looked at every time a company asked the FDA for an approval, with similar trends. One caveat to the data is that rejections are only made public If the drug makers choses to share that information. In 2008, the FDA approved 56 precent of approval requests; 75 out of 134 were approved. This figure remained relatively unchanged in 2009 and 2010 and increased to 70 percent in 2011, 2012 and 2013. The approval rate rose to 77 percent last year and jumped even more this year, to 88 percent.
These numbers are especially important in light of the new 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 speed up approval, 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.