Critics Question FDA High Approval Rate for New Drugs

Just a few years ago, the Food and Drug Administration (FDA) rejection rate for never-before-marketed drugs was about 66 percent, but thus far this year, the approval rate for new drug applications is 89 percent, raising questions about the approval process.

In the first eight months of 2015, the FDA has rejected only three uses for “new molecular entities,” and approved 25, for an approval rate of 89 percent, Forbes reports.

Forbes commissioned an analysis of drug approval applications from BioMedTracker, an institutional research service that tracks the pharmaceutical industry. BioMedTracker differs slightly from the FDA in how it counts the results of applications for new molecular entities. BioMedTracker looks at every use of a new medicine and, for example, it counted the rejection of the new antibiotic Avycaz (ceftazidime-avibactam) for hospital-acquired pneumonia and the rejection of the request to sell the diabetes drug Jardiance (empagliflozin) in combination with metformin, although both drugs received approvals for other uses. Eliminating BioMedTracker’s counting of multiple uses for the same drug means the FDA approved 23 drugs and rejected one, the anesthesia antidote, Bridion (sugammadex). This means that 19 of 20 new drug applications were approved.

BioMedTracker says that in 2008 the FDA approved 20 new molecular entities (NMEs) and rejected 20, an approval rate of 50 percent. In 2009, the NME approval rate fell to 44 percent. The rate was 86 percent in 2011, but it fell to 60 percent in 2013, and then rose to 88 percent in 2014. Forbes warns of a flaw in the data: drug approvals are made public but rejections are not and the drug maker may not announce a rejection, making rejections more difficult to ascertain. For the Forbes analysis, BioMedTracker looked at every time a company asked the FDA to either approve a new drug or approve a new use for an existing medicine. In 2008, companies asked for 134 approvals and got 75 (56 percent approval rate). That rate held in 2009 and 2010, rose to about 70 percent in 2011, 2012, and 2013 and then jumped to 77 percent in 2014, with 97 out of 126 requests approved. The new female libido drug Addyi stirred concerns about the approval process, but Forbes says the odds of rejection were low, and Addyi’s approval was announced last week.

The FDA attributes rising drug approval rates to the fact that the agency is doing its job well and is meeting deadlines in the approval process. In addition, the FDA has new procedures for communicating with drug makers before they file new drug applications, thus improving the chances that an application will succeed. The FDA is also consulting patient advocates about what they want. In many instances, sick patients want the FDA to approve a drug, even if it’s predicted to have marginal benefit.

Legislation before Congress—the 21^st Century Cures Act—would further speed up approvals and remove red tape. But critics warn of the risks in speeding up approvals. Vioxx and Avandia, which were approved in 1999 during a boom in approvals, became the center of safety scandals. Ultimately, Vioxx was withdrawn from the market and Avandia’s use is now severely restricted, according to Forbes. Streamlining the approval process has the upside of getting drugs to the market faster, giving patients more treatment options, but the downside to the speed can be the approval of dangerous drugs.

 

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