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FDA Criticized for Too-High Approval Rate for New Drugs

Aug 24, 2015

As recently as 2008, drug companies filing applications with the Food and Drug Administration (FDA) for never-before-marketed drugs faced rejection about 66 percent of the time.

Thus far in 2015, the FDA has rejected only three uses for new chemical entities—referred to as "new molecular entities"-and approved 25, an approval rate of 89 percent, according to Forbes.

Forbes arrived at these numbers through an analysis it commissioned from BioMedTracker, an institutional research service that helps investors track the pharmaceutical industry. BioMedTracker has a slightly different way of following new molecular entities than the FDA does. BioMedTracker looks at every use of a new medicine and, for example, 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. 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.

In 2008, BioMedTracker says, 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, with 28 uses rejected and 22 approved. The rate rose to 86 percent in 2011, fell to 60 percent in 2013, and rose to 88 percent in 2014. BioMedTracker follows every request for an approval, Forbes reports. (A caveat about the data: drug approvals are a matter of public record, but rejections are not and drug makers may not make them public.) 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. Despite arguments about the fairness of the process, Forbes says the odds of rejection for the new female libido drug Addyi were low at best. The approval was announced last week.

The FDA claims drug approval rates are going up is because it is doing its job: the agency is meeting deadlines in the approval process and has new procedures for communicating well with drug makers before they file new drug applications, improving the chances the application will succeed. The FDA is also consulting patient advocates about what they want. Many sick patients want the FDA to approve a drug with even marginal benefits.

The 21st Century Cures Act, a bill before Congress, would further speed up approvals and remove red tape. But there are risks in speeding up approvals, Forbes warns. Vioxx and Avandia, two drugs approved in 1999 during a boom in approvals, became the center of drug safety scandals. Vioxx was ultimately withdrawn from the market and Avandia had its use severely restricted. There is an unresolved tension between getting drugs to market faster to give patients treatment choices and concerns about not approving dangerous drugs.

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