Congresswoman McCollum's Statement on the Food and Drug Administration Reform Act of 2012 (H.R. 5651)
Mr. Speaker, I rise today in strong support of the Foodand Drug Administration Reform Act of 2012 (H.R. 5651), which will strengthen Minnesota’s health care system and economy.
The Foodand Drug Administration Reform Act reauthorizes the FDA’s drug and medical device user fee programs at a critical time. If these user fees are not reauthorized before the end of June, the FDA will not have the funding it needs to ensure life-saving drugs and medical devices are available to patients in a timely fashion. This bill also accelerates approval of treatments to address rare diseases, reauthorizes two successful pediatric programs, and helps to prevent drug shortages that are affecting families across the country. Overall, the reforms in H.R. 5651 bring the FDA into the 21st century by making the agency more responsive to changes in the U.S. health care system and better equipped to oversee a globalized market for medical products. This legislation will deliver safer treatments, faster innovation and better care for millions of American patients and families.
This legislation is especially important for America’s medical device sector. The approval process for medical devices at the FDA slowed by as much as 60 percent since 2005, according to the General Accountability Office. While longer approval times have not improved patient safety, they have delayed or even denied life-saving treatments to patients and undermined the international competitiveness of the U.S. medical device industry. There is general agreement that the broken approval process for medical devices is doing real harm to patients and workers. This is especially concerning for Minnesota because our state is a hub of medical device innovation; the sector employs thousands of highly-skilled workers in our state. H.R. 5651 reforms and reauthorizes the medical device user fee program through fiscal year 2017, providing years of stability and increased regulatory certainty for companies that range from local small business start-ups to global Fortune 500 enterprises. Moreover, the bill will foster innovation in the sector by speeding market access for new and improved medical devices without compromising patient safety.
The Foodand Drug Administration Reform Act is a rare bipartisan success story. This legislation comes to the House floor after months of close bipartisan collaboration. The Senate approved a bill very similar to H.R. 5651 by a vote of 96 to 1. The House Energy and Commerce Committee voted 46 to 0 to move H.R. 5651 to the floor. Both Democratic and Republican members of Congress understand that a high-quality health care system requires a strong and effective FDA. Today’s bill is a major step forward for the FDA and a demonstration of legislative compromise for the good of the American people.
I urge all my colleagues to support H.R. 5651 and yield back.