Mixed Signals onReversing Course These comparative studies come to light as E.U. lawmakers delibe

Mixed Signals onReversing Course

These comparative studies come to light as E.U. lawmakers deliberate over a proposed recast of medical device regulations. Although the studies largely are U.S.-centric, the comparative efficiency researchers found in the E.U. model should bolster arguments to preserve many of the existing European regulatory paradigms.

John Wilkinson, CEO at European medical device trade association Eucomed, has done just that, seizing upon the studies as evidence that the E.U. regulatory model strikes an appropriate balance between innovation and safety. In reaction to the BCG/AdvaMed study, Wilkinson said, “…We believe that the current concept of decentralized oversight must remain.”

Will the cumulative effect of these studies prompt U.S. regulators to adopt an approach more similar to the EU approval process? Some recent steps by the agency indicate some willingness to address industry concerns—but only some. The agency announced in February an initiative to facilitate expedited PMA processes for cutting-edge Class III devices, and has delayed its long-awaited decision whether to require some 510(k) applicants to provide clinical data along with their submissions, with no final decision until at least July 2011.

Furthermore, Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, was cited in a Feb. 9 article in The New York Times acknowledging the benefits of a more consistent and predictable review process—but then dug in his heels, asserting that the European approval system has pursued efficiency at the expense of safety and stating that the U.S. regulator had no plans to “relax its standards.”

Shuren added, “We don’t use our people as guinea pigs in the U.S.,” subsequently spawning a transatlantic spat between U.S. and E.U. regulators. The European Commission’s health and consumers department head Paola Testori Coggi sent a letter to FDA Commissioner Margaret Hamburg on Feb. 18 casting Shuren’s remark as an attempt to publicly discredit the European regulatory process for medical devices, the Reuters news service reported. She furthermore requested evidence from the FDA of any unsafe devices currently marketed in Europe. (The FDA so far has not provided any.)

In light of the tightening regulatory climate in the United States, the imminent recast of E.U. medical device legislation should be monitored with great interest.