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March 23, 2007

2007

March 23, 2007

TUBERCULOSIS

Global and Domestic TB Control Legislation Introduced in the House

Just in time for World TB Day on March 24th, legislation aimed at eliminating TB in the U.S. and globally has been introduced in the House of Representatives. The Comprehensive TB Elimination Act, H.R. 1532, sponsored by Reps. Green (D-TX), Wilson (R-NM) and Baldwin (D-WI), was introduced on March 15th, and the Stop TB Now Act, sponsored by Reps. Engel (D-NY), Wilson (R-NM) and Smith (D-WA), was introduced on March 19th.

Just in time for World TB Day on March 24th, legislation aimed at eliminating TB in the U.S. and globally has been introduced in the House of Representatives. The Comprehensive TB Elimination Act, H.R. 1532, sponsored by Reps. Green (D-TX), Wilson (R-NM) and Baldwin (D-WI), was introduced on March 15th, and the Stop TB Now Act, sponsored by Reps. Engel (D-NY), Wilson (R-NM) and Smith (D-WA), was introduced on March 19th.

Domestic TB Bill

The Comprehensive TB Elimination Act, H.R. 1532 will provide the US Public Health Service with the resources needed to eliminate TB in the US and play a leading role in eradicating the disease globally. It will give the Centers for Disease Control (CDC) authority to respond to international outbreaks of XDR-TB, increase funds for the Center's National Program for the Elimination of Tuberculosis and expand research on TB diagnostic and treatment tools at the National Institutes of Health (NIH) and CDC. Key provisions of the bill will:

  • Expand CDC sponsored research on the safety and efficacy of new drugs, diagnostics and vaccines, and studies of populations at risk for TB
  •  Authorize and expand CDC demonstration activities on TB elimination, including targeted efforts to prevent, detect and treat the disease among African Americans and foreign-born persons in the U.S.
  •  Expand research, including study of the relationship between TB and HIV/AIDS, and research training programs at the NIH
  •  Authorize funding for the "Blueprint Plan for TB Vaccine Development" at the National Institutes of Allergy and Infectious Diseases (NIAID)

International Bill
The Stop TB Now Act, H.R. 1567, implements the recommendations of the World Health Organization (WHO) plan for controlling tuberculosis globally and increases funding for global TB control at the U.S. Agency for International Development (USAID) and CDC. The bill will:

  • Enhance US technical assistance in responding to the global TB crisis
  • Support international TB control activities at the USAID and CDC, including expansion of directly observed treatment short-course (DOTS) coverage, strengthening of health systems, and promotion of the International Standards of TB Care
  • Increase US funding for international TB control

A Senate companion bill to the Comprehensive TB Elimination Act is being prepared for introduction soon and the ATS will alert members when it is introduced. The Senate version of the Stop TB Now Act is being sponsored by Sen. Boxer (D-CA) and she is expected to introduce it within the next few weeks.

The ATS played a key role in working with members of Congress to draft the legislation.  The ATS will continue it work with partner organizations to seek enactment of the two tuberculosis control bills this Congress.

House Foreign Affairs Committee Holds TB Hearings
This week, the House Africa and Global Health subcommittee, chaired by Rep. Donald Payne (D-NJ), held a hearing on the Stop TB Now Act and the global health threat of extensively drug-resistant (XDR) TB.  The hearing included testimony from CDC director Julie Gerberding MD, MPH, WHO STOP TB Program Director Mario Raviglione MD, USAID Global Health Assistant Administrator Kent Hill and U.S. Department of State Global AIDS Coordinator Mark Dybul.  Also testifying at the hearing was the STOP TB Now Act sponsor Representative Eliot Engel (D-NY).

PEDIATRIC LUNG HEALTH

Pediatric Medical Devices Legislation Reintroduced in the House
Legislation to speed the development of medical devices designed for children was introduced this week in the Senate by Sen. Dodd (D-CT) and in the House by Rep. Markey (D-MA). The bill, entitled the Pediatric Medical Device Safety and Improvement Act, S. 830 and H.R. 1494, offers incentives to manufacturers of medical devices for children, grants the Food and Drug Administration (FDA) authority to require post-market studies of devices to ensure their safety and efficacy, and enhances and coordinates research efforts at the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ) and the FDA.

Currently, many essential medical devices, such as mechanical ventilators, CPAP and BIPAP machine and other respiratory assistive devices are not designed or sized for children because the market for pediatric devices is smaller than the adult market. The lack of devices designed specifically for children limits treatment options for children with respiratory-related disease. 

In October 2004, the Food and Drug Administration (FDA) released a report that identified barriers to the development and approval of devices for children. The Institute of Medicine (IOM) then issued a July 2005 report on post-market surveillance of pediatric medical devices that found serious flaws in safety monitoring and recommended expanding the FDA's ability to require post-market studies of certain products and improving public access to information about these studies.  

The Senate Health, Education, Labor and Pensions Committee (HELP), chaired by Sen. Edward Kennedy (D-MA), plans to hold a March 27 hearing on pediatric medical devices and the need for additional testing of medications for children.

The ATS Health Policy Committee worked closely with the American Academy of Pediatrics to develop the legislation introduced by Sen. Kennedy.  The ATS will continue to work with partner organizations to secure enactment of the pediatric device legislation.

CLEAN AIR

Clean Air Scientific Advisory Committee Recommends Lower Ozone Standard
The Clean Air Scientific Advisory Committee (CASAC) at its March meeting unanimously recommended a tightening of the current EPA standard for exposure to ozone to a standard between 0.060 parts per million (ppm) and 0.070 ppm.  The current EPA standard is 0.080 ppm.

CASAC is an expert panel convened by EPA to provide technical assistance on reviewing air pollution research and provide recommendation to the EPA during the standard setting process.  In issuing its recommendation, CASAC explicitly rejected the idea of retaining the current standard of 0.080 ppm.  Maintaining the current standard was one of the options present by EPA staff. 

CLINICAL PRACTICE

Pulmonary Rehabilitation Legislation Picks Up More Cosponsors
Support for the pulmonary rehabilitation legislation (S. 329/H.R. 552) continues to grow in Congress, with 31new House cosponsors and 3 new Senators added in the past three weeks.  The bills, introduced by Senators Lincoln (D-AR) and Crapo (R-ID) and Representatives Lewis (D-GA) and Pickering (R-MS), would establish an explicit benefit category for pulmonary rehabilitation in the Medicare statute. 



Points of Contact

Gary Ewart Senior Director, Government Relations
Nuala Moore Senior Legislative Representative
Joe Kirby DC Office Administrator