President Bush Signs Community Health Center Reauthorization, Medical Device User Fee Bills

President Bush on Saturday signed a bill (S 1533) to reauthorize the federal community health centers program and a second bill (HR 3580) to reduce FDA review times for medical devices, the AP/Augusta Chronicle reports (AP/Augusta Chronicle, 10/27). The first bill renews federal support for the community health centers program for five years. The legislation allocates $1.3 billion in federal funds for community health centers, reauthorizes the National Health Service Corps and provides $146 million in scholarships and loan repayment incentives for health providers who work in underserved areas. The bill also establishes a $40 million grant program to improve quality of care in rural areas and provides $50 million over five years to communities and provider groups to "develop or strengthen integrated health care delivery systems" (California Healthline, 10/17). Although the bill establishes rules for federal expenditures, lawmakers must approve the funds to finance the bill, the AP/Chronicle reports. Announcing the bill's signing in his weekly radio address on Saturday, Bush said, "The quality of American medicine is excellent, yet too many Americans live in communities lacking good clinics and basic health care. Community health centers are America's health care safety net, providing prenatal care, checkups and preventive treatments to anyone who walks in the door."

Bush also signed a bill that allows medical device manufacturers to pay user fees to speed FDA reviews of their products, the AP/Chronicle reports (AP/Augusta Chronicle, 10/27). Under the legislation, medical device manufacturers can pay user fees to hire private companies to inspect their manufacturing facilities and review applications, functions performed today by the FDA. The user fees will allow the FDA to hire more inspectors; the FDA will retain the authority to conduct inspections under the bill. The legislation also establishes an FDA office of combination products and allows medical device manufacturers to submit proposals for labels electronically. The legislation requires the FDA to establish rules for labels on medical devices developed for one-time use that can be proven safe for reuse when cleaned (American Health Line, 10/18). "Medical devices are often very complex and require careful testing before they're approved by the FDA, but the FDA is overwhelmed by the volume of new technologies, making delays more frequent and undermining the quality of device reviews," Bush said, adding, "Under the new law, we're going to speed up and improve the approval process. The entire nation will benefit from faster approval of lifesaving innovations" (AP/Augusta Chronicle, 10/27).