Q&A - August 18, 2025
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This week’s questions:
Why has CDRH seemed uniquely untouched by this year’s upheaval at the FDA?
How does the WSJ editorial on drug approvals (here) relate to your late July article (here) calling for a National Agenda for Advancing Therapies for Chronic Progressive Diseases?
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Q: Michelle Tarver at the Center for Devices and Radiological Health (CDRH) has been uniquely untouched by this year’s upheaval at the FDA. She is, of course, particularly skilled at her job, but so were many other people who are no longer at FDA. What other factors might have helped to protect her?
A: For purposes of answering the question, I am going to assume that “CDRH has been more stable than the other centers” is correct. It certainly appears to be true.
The subscriber who submitted the question offered one theory: devices just aren’t as politically high-profile as most other regulated medical products, which has made it easier for CDRH and its director to fly under the radar.
I agree, but the relative lack of visibility has little to do with politics...and nearly everything to do with the nature of the drug and device industries and how their products are developed and regulated. Generally, medical devices are more numerous, face more product-to-product competition, are parts of broad product portfolios, and are created and incrementally improved within comparatively short innovation cycles.
Medical devices rarely fit into the pharmaceutical paradigm — a billion dollars invested over a decade or more, with each product eventually ending in an “all-or-nothing” decision by FDA and “all-or-nothing” revenue for the company. While patients need both drugs and devices, any given medical device approval is far less consequential than most drug approvals. This is reflected in the numbers — CDRH handled 24,400 device submissions in 2024, more than all the drugs and biologics on the market (here).
The timing of Dr. Tarver’s appointment to lead CDRH may have also helped. While she has had a long career at FDA, she was only made the permanent leader of CDRH in October 2024. She was not part of Commissioner Califf’s leadership team in the same way as Jim Jones (Human Foods), Dr. Cavazzoni (CDER), and Dr. Marks (CBER).
I was in a similar situation many years ago, and the incoming leadership decided that I had no loyalty to the old regime and could be reliably treated as one of their own. That may or may not have been a factor in the decision (thus far) not to replace Dr. Tarver.
Q: The Wall Street Journal Editorial Board published a column (here) that was critical of the FDA’s approach to approval of therapies for deadly and rare diseases. How does the WSJ position relate to your late July article (here) calling for a National Agenda for Advancing Therapies for Chronic Progressive Diseases?
A: We are both pulling in the same direction--as a response to recent decisions that seemed inconsistent with past policies and heedless of the plight of the many rare disease patients who face severe disability and death.
However, the WSJ argues from specific examples (drugs from Replimune and Stealth), thus mirroring the case-by-case approach that has dominated orphan drug thinking at the agency. A notable (and unfortunate) feature of this approach is that sponsors (companies), patients, and the FDA are often forced to engage in repeated disputes over clinical development issues on which the FDA should already have established policies and guidance to inform its case-by-case evaluation of NDAs and BLAs.
My column argues for a more systematic approach to addressing the needs of patients meeting three conditions:
Their disease is progressively debilitating and/or fatal (i.e., they legitimately cannot wait for safer and more effective treatments to be developed and approved),
They are willing to take on a lot more “safety risk” and “efficacy uncertainty” for even the slightest chance of a benefit, and
They are dealing with complex heterogeneous diseases that, regardless of patient population size, will make drug discovery and development difficult.
If prompted, I hope the WSJ would see it the same way I do. They should advocate for the resolution of the current disputes in the context of—and as a step toward—reducing and narrowing the uncertainty that will otherwise be at the heart of future conflicts. Sponsors (companies) and patients would greatly appreciate more comprehensive guidance from the agency.
If any FDA Matters subscriber can help bring my perspective to the attention of the WSJ Editorial Board, please assist me in doing so.