More physicians understand the FDA's approval process for drugs than they do for medical devices, according to findings from a survey published Jan. 16 in Health Affairs.
Researchers from the University of California San Francisco, Boston-based Brigham and Women’s Hospital, and Harvard University in Cambridge, Mass., randomly polled 509 physicians to better understand how their knowledge of and familiarity with FDA approval processes plays into making clinical decisions.
According to the findings, 41% of physicians understand the FDA's drug approval process, but only 17% of physicians understand medical device approval, researchers found.
Even though the results reveal that more physicians are familiar with drug approval processes, still more than half — 59% — did not claim moderate or better understanding of FDA drug approval processes; and 83% did not have moderate or better understanding of approvals for medical devices.
"Our findings suggest that physicians commonly lack familiarity with drug and medical device regulatory practices and are under the impression that the data supporting FDA drug and high-risk device approvals are more rigorous than they often are," the authors of the study wrote.
In the survey, some physicians also reported they believe the FDA has become too "lenient" with some of the approval processes, and want more in-depth, premarket evidence of drugs and devices before being approved so they can have confidence recommending them to patients, a news release from UCSF about the study, explained.
"Physicians overwhelmingly felt that randomization, blinding and meeting primary endpoint thresholds were important characteristics of trials used to support regulatory approval," Sanket Dhruva, MD, lead author and cardiologist and assistant professor of medicine at UCSF stated in the release. "Despite these preferences, the proportion of studies leading to FDA approval that feature these characteristics has fallen in recent years."