FDA Approved 65 Percent Of New Drugs In 2022 Based On A Single Study

According to a research letter published on August 8 in the Journal of the American Medical Association Network Open, 24 of the 37 drugs approved in 2022 by the U.S. Food and Drug Administration were based on a single study, with only four drugs having more than three studies to support their approval.

According to the research letter, most of the 413 studies evaluating the 37 drugs approved in 2022 were sponsored by the industry-meaning they were manufactured, funded, and analyzed by the company producing the product, seeking FDA approval, and standing to benefit financially from the drug.

Of the studies available for analysis, only 25 percent of study results have been made publicly available, with the results of six percent of those studies published after the FDA had already approved the drug for use.

Researchers found that only 55 percent of studies evaluating drugs in 2022 consisted of randomized clinical trials-the "Gold standard" of evidence-based medicine-despite the FDA justifying most approvals based on randomized clinical trial data.

For comparison, only 20 percent of medical products in 2016 were approved based on a single study, and 55 percent were approved based on three or more studies, whereas 65 percent of drugs in 2022 were approved based on a single study, with only 11 percent having three or more studies.

"These products are sometimes approved on as little as a single observational study with fewer than 20 subjects once approved, the drug's price increased one million to three million dollars per treatment and was fully covered by the taxpayer and private insurance-driving the costs of premiums."

The Cures Act gave new authority to the FDA to "Recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs" and directed the agency to create one or more intercenter institutes to assist with coordination of activities between the drug, biologics, and device centers to improve the regulation of combination products. 

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