The U.S. Food and Drug Administration has been approving new prescription drugs quicker than ever over the past few decades, but a recent study suggests there’s a major problem with the process. According to the study, published in JAMA, nearly half of recent approvals for new drugs were based on only one clinical trial.
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In past years, the FDA has typically based approvals off of two or more clinical trials. But when researchers analyzed FDA drug approvals from 1983 to 2018, they found that the average number of new drug approvals per year increased to 41 in the 2010s, from 34 in the 1990s. They examined changes in laws and regulations and industry funding, and they discovered that new drugs are getting pushed through the FDA approval process much faster than before. Between 1986 and 1992, the median review time for a standard drug application was 2.8 years. In 2018, it was 10.1 months.
The change has resulted in an abundance of prescription drugs on the market, but less proof that they are effective — or safe.
Lead study author Johnathan Darrow explained, “There has been a gradual erosion of the evidence that's required for FDA approval.” He added that as a result, patients and physicians “should not expect that new drugs will be dramatically better than older ones.”
The researchers note that faster approval was the primary goal of many FDA changes, starting in the 1980s, when drugmakers began paying fees to help fund the review process. "There is some concern about the incentives that this is created within the FDA," Darrow noted. "And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry."