Article reprinted from "The Gray Sheet" - March 1, 2010
Office of Device Evaluation Director Donna-Bea Tillman will step down March 26 to join Microsoft's health unit, she said in a March 1 email to staff.
Article reprinted from "The Gray Sheet" - March 1, 2010
Office of Device Evaluation Director Donna-Bea Tillman will step down March 26 to join Microsoft's health unit, she said in a March 1 email to staff.
Tillman will be the director of Regulations and Policy for Microsoft Health Solutions Group, which develops health information technology products.
Christy Foreman, ODE's deputy director for Engineering and Science Review, will temporarily serve as ODE director while a permanent replacement is sought, according to Tillman.
Tillman has led the FDA device center's pre-market review office since 2004 and has been a staffer with ODE for 15 years. She joined the agency soon after completing a Ph.D. in biomedical engineering.
External Pressures High, But No Sign Of Force Out
Tillman is largely well-liked by device companies, despite frustrations with what many in industry complain is an increasingly burdensome review process.
But pressure on Tillman's job has grown in recent years in response to growing complaints by lawmakers, patient advocates and some internal staff at ODE that the device review process has become too lenient.
Tillman was harshly criticized in letters written to lawmakers and administration officials in 2008 and 2009 by a handful of anonymous ODE staffers. The letters suggested, among other charges, that she and her management team pressured reviewers in some instances to recommend approval or clearance of devices against their scientific judgment ("The Gray Sheet" Jan. 12, 2009).
In particular, the letters alluded to strong disagreements between ODE/CDRH management and reviewers in the Radiological Devices Branch over approval of computer-aided detection devices. The tensions were likely one underlying factor in the recent transfer of the radiological branch from ODE to the Office of In Vitro Diagnostic Device Evaluation and Safety ("The Gray Sheet" Feb. 1, 2010).
Tillman was also in the middle of the controversy that has developed around the December 2008 510(k) clearance of ReGen Biologics' Menaflex knee implant. Scrutiny of that clearance process has become a major catalyst for ongoing efforts to reform the 510(k) program.
A report issued last September by FDA following an internal investigation identified no evidence of Tillman inappropriately exerting pressure on staff to clear the device. She had determined the device to be not substantially equivalent to predicates over several rounds of review before changing her position in 2008 following an advisory panel meeting.
However, the report noted that "external pressures may have distorted" her decision-making process, and that her decisions also may have been impacted by her "sense of professional loyalty" to then-CDRH Director Dan Shultz.
Schultz resigned from his position last summer after 15 years at CDRH ("The Gray Sheet" Aug. 17, 2009).
Schultz and Tillman joined the FDA device center the same year. She became a deputy director for ODE in 2003 when Schultz was director of the office. She took the helm of the review office when Schultz moved up to the CDRH directorship.
Tillman gave no sign in her email to staff March 1 that she was in anyway pressured to step down; she expressed full confidence in the current device review process.
"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 wrote.
Tillman Has Consistently Focused On IT Issues
In the email, Tillman described a growing interest in the potential for health information technology to "improve health outcomes, and to help reduce the skyrocketing cost of health care."
Her new job "will allow me to combine what I have learned during my years at FDA with my lifelong love for all things computer and my passion for public health."
An interest in IT matters has pervaded her tenure at CDRH. Tillman was ODE's software coordinator in the late 1990s. And later, as director of ODE, she prioritized improving outdated systems to make the review process more electronic and less paper-based ("The Gray Sheet" Sept. 5, 2005).
Tillman also has been active in developing CDRH's burgeoning policy for overseeing electronic health records. She chaired an ODE working group on the topic that formed in 2009 ("The Gray Sheet" March 30, 2009).
Coincidentally, current CDRH Director Jeffrey Shuren signaled last week at a Health and Human Services IT meeting plans for the center to increase its role in regulating electronic health records ("The Gray Sheet" March 1, 2010).
– David Filmore
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