61% of drugs receiving fast-tracked FDA approval shown to have low therapeutic value

An August study published in the JAMA Health Forum found that between 2008 and 2021, of the 146 drugs receiving fast-tracked approval from the FDA, 61 percent were shown to have low therapeutic value. 

The study identified fast-tracked drugs in Europe and the U.S., and tracked their therapeutic value ratings to judge effectiveness at treating clinical conditions. 

The study determined that 39 percent of the medications granted accelerated approval had therapeutic effectiveness, and 38 percent that were granted conditional market authorization had effectiveness. 

Out of 146 medications, 122 were for cancer treatment. 

In 2020, 53 percent of cancer-related drugs were fast tracked by the FDA.

In 1992, the FDA created an accelerated drug pathway for medications that could end serious diseases.

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