Another senior FDA official involved in the botched ReGen Biologics clearance process has left the FDA.
Tillman Leaves FDA for Microsoft
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Donna-Bea Tillman, Ph.D., issued an email to her colleagues at the device division at the FDA on March 1 that said she was joining the Washington office of Microsoft Corp. Dr. Tillman has been with the FDA’s Center for Devices and Radiological Health since 1994.
In the email, Tillman, who has a doctorate in biomedical engineering from Johns Hopkins University, said she was interested in the potential for health IT to “reduce the skyrocketing cost of health care.”
She added, “One thing that gives me comfort is the knowledge that you all will continue to do the same great work that you have always done, so that the next time I am in need of a medical device, I can be confident in its safety and effectiveness.”
She was at odds with some FDA staffers over the agency’s decision to decide that ReGen’s Collagen Scaffold had a predicate device and could therefore enter the market through the 510(k) clearance process instead of the more expensive PMA (premarket approval) process.
Dr. Tillman will become part of Microsoft’s development efforts in medical information technology systems and expand the profile of the company’s health group in Washington. She said she would not personally lobby on behalf of the company.
A September 2009 internal FDA report on the ReGen clearance process said the decision-making process by Tillman, the ODE director, “may have been affected by her sense of professional loyalty.” The report added, “The ODE director felt a duty to back the center director who by then had decided in favor of granting approval under the abbreviated process.”
The director of the device division, Dan Schultz, M.D., resigned last August, before the release of the ReGen report. Dr. Schultz joined Greenleaf Health in January 2010.
Dr. Tillman said her departure was not related to the ReGen issue.
The FDA’s orthopedic panel is meeting at the end of March to take another look at ReGen’s device.
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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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