Improved Education Needed for FDA Approval Terminology


FDA approved and “breakthrough therapy” are two commonly used phrases in regards to pharmaceuticals, but physicians may not fully understand the meaning of these terms.

Physicians have a limited knowledge of what terminology regarding an FDA approval means, a recent study found.

Since 2012, the FDA has been able to label a drug as a breakthrough therapy if preliminary clinical evidence suggests this drug may be better than any existing options.

A study published in JAMA asked 1148 physicians different questions regarding FDA approval and breakthrough therapies, with692 physicians responding.

Physicians who did reply showed insufficient knowledge of the questions asked, according to the study.

Seventy-three percent of physicians incorrectly thought that FDA approval meant that the drug showed efficacy comparable to other approved drugs.

Seventy percent of physicians also incorrectly thought that to gain FDA approval, the drug had to be statistically significant and have a clinically important effect.

In regards to the breakthrough knowledge questions, 52% of physicians incorrectly thought strong evidence was needed to earn breakthrough therapy designation.

"The misconceptions identified may lead physicians to overprescribe newly approved drugs--particularly breakthrough therapies-- and inadequately communicate how well these drugs work to the patients who will use them," the authors of the study said in a press release.

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