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FDA Hopes ‘Transition’ Results in More Responsive Agency




The U.S. Food and Drug Administration is an agency in transition.

With a change in leadership, the multi-faceted organization charged with protecting public health is undergoing a transformation that officials hope will restore credibility and confidence to the embattled agency.

The transformation began six months ago with the appointment of Margaret Hamburg, M.D., as FDA commissioner. Her appointment is considered by many in the healthcare industry as a turning point for the agency because of the importance she has placed on regulatory compliance, device safety and open communication.

Hamburg reinforced her commitment to device safety in September with the appointment of Jeff Shuren, M.D., a physician and attorney, as acting director of the Center for Devices and Radiological Health (CDRH). Shuren replaced Daniel Schultz, M.D., who resigned as CDRH director in August amid a firestorm of controversy over the Center’s device approval process.

When he assumed control of the CDRH, Shuren announced six immediate priorities for the center. First, he promised to focus on ways the FDA can adapt to changes in technology while still providing the industry with avenues that foster innovation. “A key question that we are considering is how gradual improvements in product design and safety will affect decisions about first-generation devices that are currently on the market,” Dr. Joshua M. Sharfstein said. “The Task Force on Science in Decision-Making has been convened and has begun meeting. The group will seek input from others both within and outside the FDA.”

Another priority for the CDRH is the much-publicized review of the 510(k) process, a device review system that has been under fire on Capitol Hill for several years. A report released in January from the Government Accountability Office determined that the program was inappropriately used to clear hundreds of complicated medical devices, and suggested the agency strengthen its approval standards and make them more consistent. The CDRH has convened an internal working group to explore steps the Center can take to improve the 510(k) process. “It’s bee a number of years since the device review process was set up, and questions have come up on all sides,” Sharfstein noted.

In addition to the 510(k) process review, the CDRH is working to develop a comprehensive compliance strategy, and it is considering ways to improve the integration of premarket and postmarket information. FDA officials hope the integration of data will help trigger the implementation of a total product life cycle approach to product safety. The Total Product Life Cycle (TPLC) management approach involves sharing information among various product life cycle stages and between different departments within a company. It also encourages the use of preventive actions over corrective actions, encouraging firms to develop solutions that prevent problems before they occur.

Perhaps one of the more challenging priorities for the CDRH includes the development of procedures to better communicate the rationale for decisions made by the Center and the FDA. Improved communication and more visibility into the thought process at the FDA might help restore some of the confidence consumers have lost in the agency in the wake of recent food and product recalls.

“There are times when the FDA has credibility and times it doesn’t,” Sharfstein said. “When there is confidence in the FDA, the medical device industry does well. When people question why a device was approved, for instance, that has an effect on the industry. More transparency will help people understand where we are coming from so we are not like a black box that people don’t understand.”

Another short-term priority for Shuren is the establishment of procedures for resolving differences of opinion within the CDRH. Last month, Shuren announced a new Standard Operating Procedure for resolving internal differences of opinion in regulatory decision-making. The Center also is updating its guidance on the processes for outside parties to resolve disagreements with the agency.

“At the end of this period of transition, I hope [people] see a responsive FDA, an FDA that can adapt to changing technology while setting clear standards, a credible FDA, an FDA that fosters innovation by companies to meet critical public health needs,” Sharfstein said.




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