In a recent article, three professors of medicine, Sanket S. Dhruva, Aaron S. Kesselheim, and Rita F. Redberg, shed light on the gaps in physicians’ knowledge regarding FDA drug and device regulation. They discuss how recent changes in legislation and FDA practices have impacted the evidence required for product approval. The authors conducted a survey of 509 internists, cardiologists, and medical oncologists, revealing that only 41% of physicians claim moderate familiarity with FDA’s drug approval process, and just 17% with medical devices.
The evolving regulatory landscape has led to more products entering the market through expedited pathways, resulting in lower-quality evidence supporting approvals. Post-approval studies, crucial for confirming safety and efficacy, often face significant delays. The authors highlight that limited pre-approval evidence and delayed post-approval evidence mean patients may receive FDA-approved products with unanswered efficacy and safety questions for many years.
Physicians expressed a desire for more rigorous pre-approval testing and stressed the importance of strong evidence, including randomization, blinding, sufficient follow-up, and meeting primary endpoints. The survey also found that physicians want the FDA to take action when lingering questions remain for too long, with 60% supporting temporary withdrawal of approval for products not meeting post-approval testing timelines.
To address the knowledge gap, the authors propose incorporating FDA drug and device approval processes into medical school accreditation standards, including relevant content in licensing exams, and tailoring subspecialty training to physicians’ practice areas. They emphasize the need for continuing medical education (CME) and clinical practice guidelines to include information about evidence required to support FDA approvals.
In conclusion, the authors suggest that the routine regulatory practices surrounding evidence for new approvals and post-approval commitments may need re-evaluation. While the trend has been to permit more products on the market with less rigorous data, physicians appear to be concerned about products approved based on limited testing. The authors advocate for greater rigor in both premarket and postmarket testing to align with physicians’ expectations and ensure patient safety.