Senior device regulator Tillman to leave US FDA
This article was originally published in RAJ Devices
Donna-Bea Tillman, one of the most senior medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health, is leaving the agency reportedly to take up a job with the IT giant Microsoft.
Dr Tillman, the director of CDRH’s Office of Device Evaluation, is resigning from the agency, effective 26 March1. Christy Foreman, who is currently deputy director for Engineering and Science Review at the ODE, will replace Dr Tillman as acting ODE director. According to media reports, Dr Tillman told FDA staff in an email that she intends to join Microsoft’s Health Solutions Group as director of regulations and policy2.
Dr Tillman began her career at the FDA in 1994 as a reviewer in the Obstetrics and Gynaecology Devices Branch and later went on to become chief of the Pacing and Electrophysiology Devices Branch and deputy director for the Division of Cardiovascular Devices. Prior to joining the FDA, Dr Tillman helped develop consensus standards at the Consumer Product Safety Commission.
CDRH’s top management has come in for heavy criticism in recent years. In November 2008, a group of FDA device reviewers wrote a letter to a Congressional committee accusing the CDRH’s top management of knowingly corrupting the scientific review process3.In September 2009, the FDA issued a report admitting lapses in its approval of a knee-surgery device called Menaflex manufactured by ReGen Biologics4. The report stated that the FDA had failed to respond appropriately to “external pressure” and departed from multiple standard processes, procedures and practices while reviewing the device in question.
Dr Tillman, the report said, had initially opposed clearing Menaflex under the premarket notification (or 510(k)) process, but later reversed her position in December 2008. The change of stand, the report suggested, may have happened because of “external considerations” affecting the review decisions of the ODE director5.
“The decision-making process of the ODE Director,” the report said, “may have been affected by her sense of professional loyalty” as she “felt a duty to back” the CDRH director, who at that time was Daniel Schultz and who by then had decided in favour clearing Menaflex.
Dr Schultz resigned from the FDA in August last year6 and has since been replaced by Jeffrey Shuren as CDRH director7.
510(k) process in IOM spotlight
One of Dr Shuren’s main priorities is to re-examine the 510(k) premarket notification process for medical devices to determine whether it is fit for purpose; a study by the Institute of Medicine (IOM) has been commissioned in this regard8. The 510(k) procedure has been criticised by many for not being stringent enough to ensure that only safe and effective products are cleared for sale.
On 1 March, the IOM held its first meeting on the public health effectiveness of the 510(k) process9. Industry association AdvaMed responded by issuing a statement that it looked forward to IOM conducting a thorough and objective analysis that would “dispel many of the misconceptions” about the 510(k) process10.
Besides the IOM study, Dr Shuren also set up an internal task force to evaluate and improve the consistency of FDA decision making in the 510(k) process. The first set of improvements to the process may be implemented by September11.
The FDA has already indicated that it is considering seeking more legislative authority to strengthen the 510(k) process12.
References
1. Personal communication, FDA, 1 March 2010
2. Key FDA Medical-Device Regulator to Step Down, Wall Street Journal, 1 March 2010, http://online.wsj.com/article/SB10001424052748704754604575095412328840740.html?mod=WSJ_business_IndustryNews_DHC
3. Finn K, Distinguishing Scandal from Management Problems, The Regulatory Affairs Journal – Devices, 2009, 17(1), 1
4. The Regulatory Affairs Journal – Devices, 2009, 17(6), 444-445
5. FDA, Preliminary Report, Review of the Regen Menaflex: Departures From Processes, Procedures, and Practices Leave the Basis for A Review Decision in Question, September 2009, www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM183642.pdf
6. The Regulatory Affairs Journal – Devices, 2009, 17(5), 373-374
7. Shuren named permanent head of US FDA's device unit, RAJ Devices online, 21 January 2010
8. The Regulatory Affairs Journal – Devices, 2009, 17(6), 445-446
9. IOM, Meeting 1: Public Health Effectiveness of the FDA 510(k) Clearance Process, 1 March 2010, www.iom.edu/Activities/PublicHealth/510KProcess/2010-MAR-01.aspx
10. AdvaMed press release, 1 March 2010
11. Improvements to 510(k) by September, 2012 user fees already under negotiation, RAJ Devices online, 19 February 2010
12. US FDA may seek more authority to improve 510(k) process, RAJ Devices online, 19 February 2010