110th Congress

Comprehensive Tuberculosis Elimination Act of 2007

H.R. 1532, S. 1551

Background

Tuberculosis (TB), a chronic bacterial infection caused by the microorganism Mycobacterium tuberculosis, continues to be a worldwide problem. One-third of the world’s population is infected, and there are approximately 8 million new cases of TB reported globally each year, with about 1.6 million deaths. Nearly 2 billion people, including about 10 to 15 million people in the United States, are infected with TB, and TB causes more deaths than any other infectious disease caused by a single microorganism. TB is spread through the air when an infected person coughs, sneezes, or talks. It usually infects the lungs; however, it can also damage other parts of the body. TB poses a particular problem for the 40 million people living with HIV; approximately one-third of these individuals are co-infected with TB, and globally TB is the leading cause of death among those with HIV. Adding to the burden that TB presents is the increase in the number of cases of TB that are resistant to several of the standard therapeutic drugs, known as multidrug-resistant (MDR) TB. Lately, there has also been an increase in the number of cases of extensively drug-resistant (XDR) TB, which is resistant to four or more standard drugs. As a result, research aimed at the diagnosis, treatment, and prevention of all forms of TB and the care of infected individuals continues to be of interest to Congress.

In keeping with the significant problems caused by the disease and the threat posed by MDR and XDR TB, the National Institutes of Health (NIH) continues to maintain a strong TB research portfolio, with an estimated funding level of $172 million in fiscal year (FY) 2007. The National Institute of Allergy and Infectious Diseases (NIAID) is the lead Institute for TB research at NIH. NIAID’s research program encompasses studies on the pathogenesis, epidemiology, and natural history of TB and basic and applied research to develop new ways to diagnose, treat, and prevent TB, as well as clinical and translational research. The Institute has a longstanding commitment to the development of better therapies for and vaccines against TB, and on June 6, 2007, it released its research agenda for MDR and XDR TB. In addition, significant emphasis on TB research is included in the Trans-NIH Plan for HIV-Related Research developed by the NIH Office of AIDS Research.

Provisions of the Legislation/Impact on NIH

H.R. 1532 would require the Director of the National Heart, Lung, and Blood Institute (NHLBI) to expand, intensify, and coordinate research and development and related activities of the Institute regarding TB and would authorize the Director of NHLBI to provide awards to faculty of schools of medicine and osteopathic medicine for curriculum development and awards to support the career development of clinically trained professionals committed to research on pulmonary infections and TB. The Director of NHLBI would also be authorized to provide awards to faculty of schools of medicine or osteopathic medicine for curriculum development to increase opportunities for individuals, including students, practicing physicians, and nurses, to gain skills in the prevention, management, and control of TB. The bill would also amend Section 447A of the Public Health Service Act to require NIAID to include the development of a TB vaccine in its related research activities. These activities would be carried out in accordance with the blueprint described in a 1998 report from a workshop convened by the Advisory Council for Elimination of Tuberculosis, the Director of NHLBI, and the Director of the National Vaccine Program. In addition, H.R. 1532 would require the Fogarty International Center (FIC) to expand, intensify, and coordinate its international activities with respect to TB research and training.

Provisions of the bill would establish a loan repayment program for TB and require the Secretary of Health and Human Services (HHS) to ensure that for FY 2008 and subsequent fiscal years a portion of the funds appropriated to carry out selected NIH Loan Repayment Programs (LRPs) is reserved for this newly created LRP.

As introduced, S. 1551 would amend the Public Health Service Act with respect to making progress toward the goal of eliminating TB. Specifically, the bill would require the Director of NIH, rather than the Director of NHLBI, to expand, intensify, and coordinate research and development and related activities regarding TB and would authorize the Director of NIH to provide awards to faculty of schools of medicine, osteopathic medicine, nursing, public health, and related fields for curriculum development and to support the career development of clinically trained professionals committed to research on pulmonary infections and TB. The bill would also amend Section 447A of the Public Health Service Act to require NIAID to include the development of a TB vaccine in its related research activities and would require FIC to expand, intensify, and coordinate its international activities with respect to TB research and training.

During committee markup of the bill, NIH-specific provisions were amended to authorize, rather than require, the Director of NIH to expand, intensify, and coordinate relevant research, and the authorization for TB academic awards, requirement regarding NIAID activities to develop a TB vaccine, and requirement that FIC expand its relevant international activities were removed. As in H.R. 1532, provisions of S. 1551 as introduced would require the Secretary of HHS to ensure that for FY 2008 and subsequent fiscal years a portion of the funds appropriated to carry out selected NIH LRPs is reserved for a newly created TB LRP. This requirement was also removed during committee markup.

Status and Outlook

H.R. 1532 was introduced by Representative Gene Green (D-TX) on March 15, 2007, and was referred to the House Committee on Energy and Commerce. The measure had two original cosponsors, Representatives Heather A. Wilson (R-NM) and Tammy Baldwin (D-WI). No further action has occurred on this legislation.

S. 1551 was introduced by Senator Sherrod Brown (D-OH) on June 5, 2007, and was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP). The measure had four original cosponsors, Senators Hillary Rodham Clinton (D-NY), Kay Bailey Hutchison (R-TX), Edward M. Kennedy (D-MA), and Patty Murray (D-WA). S. 1551 was marked up on November 14 and reported out of the Senate HELP Committee on December 18 without a written report. No further action has occurred on this legislation.

April 2008