(HealthDay News) — Results from most studies supporting US drug approvals are not made available to the public 5 years after the drugs are approved, according to a study published in Health Affairs Scholar.
Researchers reviewed 46 novel drugs approved by the US Food and Drug Administration (FDA) in 2017. The team evaluated the availability of study results before approval and for up to 5 years after approval.
The 46 drugs approved in 2017 were evaluated in 1149 studies. Before approval, an average of 9.22 studies were started, and 5.82 studies were completed. For 19 of the 46 approvals, a single study supported approval.
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An average of 1.42 studies had results posted publicly prior to FDA approval, and an average of 8.38 studies had results posted publicly after approval.
Overall, 49% of studies were completed before FDA approval, 6% of studies had results posted before FDA approval, and 34% of studies had results posted before or after approval.
“Our findings suggest that important results relevant to newly approved pharmaceutical products are often not reported as required by the FDA Amendments Act,” the researchers wrote. “Prescribers, purchasers, and patients depend on transparent and rigorous review of pharmaceutical products. Our evaluation suggests we can do better.”
