Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation

Given the common use of Food and Drug Administration (FDA)-regulated drugs and medical devices, clinicians need to understand FDA regulation and clinical trial interpretation to provide optimal and informed patient care. Medical and pharmacy school curriculum guidelines recommend education on these topics, but no studies have assessed health professional student knowledge of FDA approvals. This study assessed knowledge about FDA regulation and clinical research evidence interpretation among final-year health professional students.

The authors designed a 24-item survey questionnaire that asked trainees to self-report (1) exposure to learning about FDA drug and medical device approval processes, (2) understanding of FDA approval evidence requirements, and (3) ability to critically interpret trial design and evidence. After pretesting, all 333 final-year students in the medical, pharmacy, and family nurse practitioner schools at the University of California, San Francisco were invited to complete the survey between January and April 2024.

Of 175 respondents (91 medical, 62 pharmacy, and 22 family nurse practitioner; response rate, 53%), 124 (71%) reported receiving teaching about FDA drug approvals, although 107 (90%) of these respondents described it as basic or cursory and 69 (58%) desired more teaching. Only 23 (14%) reported receiving teaching about medical device approvals. Despite 62 students (38%) rating their understanding of FDA drug approvals as moderately or extremely well, 5 (3%) correctly answered that drug approval requires neither statistically nor clinically significant results. Regarding clinical trial interpretation, only 25 students (17%) recognized the superiority of all-cause mortality end point data over surrogate measures and other end points.

Health professional students have limited understanding of the FDA approval process and the quality of evidence in studies of new medical products. Improving education about regulatory topics may strengthen how these future clinicians make decisions and communicate with patients about drugs and medical devices.