What happens when you go to the FDA with an application and the scientists within the agency disagree about the science behind your device or procedure?
New Rules When Scientists Disagree at FDA
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Secondary
These disagreements lie at the heart of the lawsuit by the FDA 9 whistleblowers over exposure to radiation. Internal disagreements and the ensuing public prosecution by The Wall Street Journal of Regen Biologics, Inc. and their appeals process brought down the company’s application and, according to some, hastened the departure from the agency of Dan Schultz, M.D., the former Director of the Center for Devices and Radiological Health (CDRH).
ReGen eventually filed for bankruptcy. Internal scientific disagreements within the agency have serious consequences when promoting public health and bringing new technologies to patients.
The FDA is trying to do something about it.
On September 4, 2012, the FDA announced the implementation a new “Standard Operating Procedure (SOP) for Resolution of Internal Differences of Opinion in Regulatory Decision-Making.”
This document sets forth the general policy for the CDRH for resolving internal differences of professional opinion and provides an approach for documentation of associated scientific, clinical and regulatory findings, perspectives and opinions.
As background for developing the SOP, the agency stated:
When any regulatory decision or action is considered, CDRH should reach an institutional position after all appropriate scientific and regulatory recommendations and perspectives are obtained, documented, and considered. This process is often complex and may involve multiple staff members and disciplines and may cross organizational boundaries. In most cases, alignment on a decision is achieved through discussion during progress toward a decision. Open and respectful discussions enhance the quality of Center decisions and it is incumbent on all Center employees to maintain an atmosphere of inclusion, professionalism, and mutual respect. In situations where differences of opinion arise during the decision-making process and are resolved through discussion, it is important that the official administrative file captures these differences and the resolution thereof.
Given the complex, multi-layered nature of decision-making and the diversity of expertise of CDRH staff, it is expected that differences of professional opinion will arise in the normal course of business. These differences may be scientific, clinical, or regulatory in nature, or some combination of the three.
When differences of professional opinion arise between peers or between an individual and their next-level manager or supervisor and cannot be resolved through discussion, and the parties are unable to align with a decision, then the procedures set forth in this policy can be invoked.
If you have business with the FDA, you’ll want to read this nine page document.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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