OBR OncologyOncologists Don’t See Eye-to-Eye With Other Specialists About FDA

Divergent Perspectives on FDA Approval Standards Highlight the Unique Challenges in Oncology

In a recent study published in Health Affairs, the disparity in comfort levels and expectations surrounding the US Food and Drug Administration’s (FDA) approval process for new drugs and medical devices between oncologists and other medical specialists, including cardiologists and internists, is examined. This research underscores the nuanced balance between the urgency of addressing life-threatening conditions and the rigor of scientific evaluation, especially in the field of oncology where the stakes are inherently high.

Key Points:

• Oncologists vs. Other Specialists: Oncologists are more comfortable than cardiologists and internists with the FDA’s lower threshold of evidence for approving new drugs and devices, particularly those that follow expedited pathways.
• Study Findings: The study, led by Dr. Sanket Dhruva at the University of California San Francisco, reveals that 58% of oncologists feel they have a moderate or better understanding of the drug approval process, compared to 38% of cardiologists and 30% of internists.
• Approval Process Knowledge: Despite some oncologists’ comfort with the process, the overall physician knowledge about FDA approval requirements is described as sparse.
• Evidence Requirements: A significant majority of oncologists (68%) believe a single randomized controlled trial is sufficient for approval, in contrast to the more stringent requirements preferred by cardiologists and internists.
• Importance of Randomization and Blinding: Although randomization is highly valued across specialties, oncologists place less emphasis on blinding in trials compared to their peers.
• Postapproval Trials: Oncologists are less inclined to support withdrawal of approval for drugs if postapproval trials are not conducted timely or at all, suggesting a pragmatic approach to utilizing new treatments in life-threatening situations.
• Regulatory and Physician Discrepancy: There is a noted gap between what physicians seek in terms of evidence and rigor and what is currently required by the FDA for approval, particularly regarding surrogate measures and postmarketing studies.

“I don’t think any prudent oncologist would hesitate to give the medication to a patient who otherwise might not be there six months later. Oncologists don’t have the comfort of that time.”
– Sriman Swarup, MD, MBA, Oncology-Hematology Specialist at Southwest Cancer Care in Sierra Vista, Arizona

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