DEVICE INDUSTRY ASSESSES IMPACT OF NEW DEMOCRATIC CONGRESS

With the Democrats taking control of the House of Representatives for the first time since 1994, the healthcare agenda will now be in the hands of some very vocal critics of HHS policy, FDA oversight and prices, particularly in Medicare.

Democrats have also taken over leadership of the Senate, and now hold a 51-to-49-seat advantage.

Based on seniority in key House committees, it appears that agency critics such as Reps. John Dingell (D-Mich.), Henry Waxman (D-Calif.) and Rosa DeLauro (D-Conn.) will shape healthcare policy during the 110th Congress.

Sen. Edward Kennedy (D-Mass.) will be taking over as chairman of the Health, Education, Labor and Pensions committee, which has lost two Republican members -- Bill Frist (R-Tenn.) and Mike Dewine (R-Ohio).

"We look forward to working with the new Congress on a variety of issues on FDA, CMS and market access," Medical Device Manufacturers Association Executive Director Mark Leahey said Nov. 8.

But Leahey wants lawmakers to ensure that "actions targeted to one or two larger players in the industry don't negatively impact the industry as a whole."

"The election may have been a sea change for some healthcare industries, but not for ours," Stephen Ubl, president and CEO of AdvaMed, said Nov. 9. " We see a strong bi-partisan commitment to renew [Medical Device User Fee and Modernization Act] in 2007."