James M. Jeffords: “the Senator's amendment at best duplicates the third-party conflict-of-interest protections in the bill and at worst…”

“the Senator's amendment at best duplicates the third-party conflict-of-interest protections in the bill and at worst unnecessarily constrains the agency. The ranking minority member, Senator Kennedy, and the FDA join me in opposing this amendment. Section 204 of the bill provides a full statutory directive to the agency adopt measures within 180 days of enactment to prevent conflicts of interest that may be involved with both an individual reviewer and with the reviewing organization. As with Senator Durbin, this was a critical concern for members of the committee. Section 204 provides full discretion to the agency to develop appropriate standards. The agency will not be limited in any way in developing these guidelines. In fact, the agency has already developed extensive conflict-of-interest guidelines as part of its existing third-party program, including protections from situations such as if the third party or any of its personnel involved in 510(k) reviews has any ownership or other financial interest in any medical device, device manufacturer, or distributor. The Senator's concerns have caused us to reexamine the important issue of preventing conflicts of interest. We commend him for doing so, but I urge a no vote.”