108th Congress

Clinical Research Act of 2004

H.R. 4779, S. 2924

Background

Academic health centers (AHCs), which consist of medical schools and their affiliated educational and clinical institutions, have a long and distinguished history of providing leadership to the Nation in enhancing the health of both their communities and society at large. AHCs have specialized capabilities, and the services they provide differentiate them from other health care entities. They assume a major role in the conduct of biomedical research, education of health care professionals, training of biomedical investigators, delivery of cutting-edge and high-technology medical services, assessment and treatment of patients with rare disorders and highly complex conditions, provision of continuous innovation in patient care, and delivery of most of the care provided to poor and uninsured patients in the surrounding community.

AHC mission-related activities are associated with extra expenses, often manifested as higher clinical costs. Prior to the advent of managed care in the late 1980s and early 1990s, AHCs depended on the generation of clinical revenue in order to cross-subsidize their essential societal mandates. However, as restrictions on spending in competitive health markets have reduced margins from clinical services, ancillary economic, regulatory, and information technology demands have also emerged to threaten the important services performed by AHCs.

In an effort to assist these institutions, H.R. 4779 was introduced by Representative Dave Weldon (R-FL) to alleviate, in his words, “rising costs, inadequate funding, mounting regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of both qualified investigators and willing participants.”

Provisions of the Legislation/Impact on NIH

• Section 4 of the bill would have required the Director of the National Institutes of Health (NIH) to award clinical research support grants to eligible AHCs in order to defray the costs of human subjects protection requirements and develop methods to meet those requirements more efficiently and cost effectively. An eligible AHC was defined as “an academic institution that receives an annual average of not less than $20 million in grant funds from DOD, DVA, and DHHS, for basic, applied, or clinical biomedical or behavioral research in the fields of dentistry, medicine, and nursing; or a consortium of such academic institutions.” The bill would have authorized $50 million for each of the fiscal years (FYs) 2005 through 2009.
• Section 5 would have authorized the Director of NIH to award clinical research infrastructure grants to eligible AHCs. An AHC could have used the grant money only for infrastructure necessary to facilitate translational research, for the initial testing of human subjects, to address impediments to the expeditious application of new science, or to address the shortage of clinical trial participants. A total of $125 million would have been authorized for each of the FYs 2005 through 2009.
• Section 6 would have authorized the Secretary of Health and Human Services to award grants to no more than five eligible AHCs to establish partnerships between the center and health care providers for the conduct of clinical trials. The purpose of the grants would have been to demonstrate how AHCs can collaborate with the practicing health care community. The bill stipulated that the Secretary could not have made an award of more than $5 million. In order to carry out this provision, $25 million would have been authorized for FYs 2005 through 2009.

Status and Outlook

H.R. 4779 was introduced by Representative Weldon on July 8, 2004, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

S. 2924 was introduced by Senator Rick Santorum (R-PA) on October 7, 2004, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action occurred on this legislation during the 108th Congress.