Med-tech landed two wins on Capitol Hill today with the introduction of a new FDA-streamlining bill and the passage of the Korea Free Trade Agreement.
Sens. Amy Klobuchar (D-Minn.), Richard Burr (R-N.C.) and Michael Bennett (D-Colo.) cosponsored the Medical Device Regulatory Improvement Act, which hit the Senate floor today.
The bill’s mandates include clarification of the pre-market approval process, revised definitions of conflicts of interest and an extensive review of the management and regulatory processes at the Center for Devices & Radiological Health.
Industry lobby AdvaMed roundly lauded the new bill as "important legislation that will help American patients to get timely access to life-saving, life-changing medical technology."
"We are especially encouraged to see the legislation’s focus on clarifying FDA data requirements, streamlining agency management processes, and its emphasis on the importance of attracting the best experts to FDA advisory committees,"AdvaMed president & CEO Stephen Ubl wrote in a press release.
Medical device makers logged another win with the passage of the Korea Free Trade Act, which had been locked up in bipartisan squabbling.
The bill was stalled over the summer as the White House refused to consider an agreement without Trade Adjustment Assistance, training support for displaced workers who may lose their jobs as a result of outsourcing. The TAA included in the today’s passing "was significantly cut, made more efficient and accountable, is sunset after 2014, and does not contribute to the deficit because it is fully offset with spending cuts," House Ways & Means Committee chairman Dave Camp (R-Mich.) wrote in a press release.
"The U.S.–Korea FTA has specific provisions addressing the concerns of the medical technology industry, and illustrates the benefits that these agreements can bring to the medical technology sector and to job creation in the U.S.," Ubl said in prepared remarks. "According to the U.S. Department of Commerce, Korea is one of the largest and fastest growing markets for medical technology. U.S. manufacturers exported over $875 million worth of medical technology products to Korea in 2010, while Korea exported $331 million in medical technology products to the United States."
"Korea is a significant and growing market for the U.S. medical technology industry," med-tech leviathan Medtronic Inc.’s (NYSE:MDT) CEO Omar Ishrak wrote in a July letter to Orrin Hatch (R-Utah), a ranking member of the Committee on Finance " It is critical that we remain competitive with our EU competitors. The health of the U.S. economy is contingent upon the ability of U.S. exporters to remain competitive in a global economy."