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June 22, 2007

2007

June 22, 2007

Headline

President Bush Vetos Stem Cell Bill

On June 20, President Bush vetoed the stem cell research bill passed by the House of Representatives earlier this month. As he vetoed the legislation, the President issued an executive order aimed at encouraging federal support of research medically useful stem cells without destroying human embryos. There was no specific ban on this type of research so it is unclear what new research opportunities will be opened up with this order.

Senate supporters have pledged to hold a vote on the bill within the next month to attempt to override the President’s veto, but it is not clear whether the bill will secure the 67 Senate votes needed.

Research

Senate Subcommittee Provides Increase for NIH; House Approves Global TB Increase

On June 21, the Senate Appropriations Committee approved its FY2008 spending bill for health research and services programs. The bill includes a funding level of $29.9 billion for NIH, which is as an increase of $1 billion (3.5%) over the FY 2007 level, and $250 million over the level in the House Labor-HHS Subcommittee bill approved June 7.

While the bill includes a $1 billion increase for NIH - $200 million of that increase is re-directed to the Global Fund for HIV/AIDS, TB and Malaria. So the overall increase for NIH is actually $800 million.

The bill also includes a funding increase for the Centers for Disease Control and Prevention (CDC), although the specific amount has not yet been made public. The House Appropriations Committee is tentatively scheduled to consider its bill during the week of July 9.

Meanwhile, the House approved its Fiscal Year 2008 Foreign Operations Appropriations bill on June 21. The bill includes an amendment sponsored by Rep. Payne (D-NJ), that provides a $50 million funding increase for global TB funding. The funding is provided for U.S. Agency for International Development (USAID) global TB control activities, including combating extensively drug resistant (XDR)TB. The ATS will work to ensure that a similar amendment will be offered to the Senate Foreign Operations Appropriations bill, scheduled to be considered within the next few weeks.

Congress Mandates Posting of NIH-Funded Manuscripts

Included in the Senate funding bill is a provision that requires authors of NIH-funded manuscripts to post a copy of the final peer-reviewed manuscript in the National Library of Medicines PubMed Central database within 12 months of official publication of the manuscript. A similar provision was included in the House funding bill earlier this month.

The mandate applies to individual scientists and not to scientific journals.

The legislative mandate changes the current NIH policy that requests, but does not require, NIH investigators to share a copy of their published NIH-funded manuscripts with PubMed Central. NIH has stated it needs to build a data-base of NIH-funded manuscripts for assist its portfolio management and to better serve the scientific community. Noting the low compliance rates with current voluntary policy, NIH requested Congress to institute the mandatory policy.

Fearing copyright and subscription issues, the ATS and many other not-for-profit scientific organizations have opposed efforts to create a mandatory post requirement. To help find a middle ground, the ATS has been participating in a pilot program – call NIH Portfolio - with NIH, where all NIH-funded articles published in the ATS journals are deposited by the ATS in PubMed Central on behalf of the authors. By publishing in the ATS journals, authors were automatically in compliance with current voluntary policy. With the pending enactment of the mandatory policy, the status of the pilot program is unclear.

Clean Air

EPA Proposes New Standards for Ozone

This week, the Environmental Protection Agency (EPA) issued proposed rules for revising the National Ambient Air Quality Standards for ozone. EPA is proposing to tighten the existing standard of 0.08 ppm/8-hours to a new standard in the range of 0.075 to 0.070 ppm/8-hours. While announcing the proposed standard, EPA also indicated that EPA is accepting comments on a range of policy options – including retaining the existing standard of 0.08.

In commenting on the standard, ATS President David H. Ingbar, MD said, “The science is clear, ozone pollution is causing unnecessary, illnesses and death in America. The proposed EPA standards fall short of providing the protection needed to keep Americans safe from ozone air pollution.”

By failing to adopt a more stringent ozone standard, EPA is ignoring the strong scientific evidence that shows real harm being caused by ozone pollution at the current standard.

To assist the EPA in analyzing and interpreting the scientific data, the EPA convened a panel of experts called the Clean Air Scientific Advisory Committee. CASAC, which included members with academic and industry backgrounds, analyzed the available data. They unanimously concluded the current standard does not protect public health and recommended a standard between 0.060 and 0.070 ppm/-8-hours.

Tobacco

FDA Bill Gets 51st Cosponsor

Legislation giving the Food and Drug Administration authority to regulate tobacco passed an important legislative milestone this week by picking up its 51 cosponsor, Sen. Amy Klobuchar (D-MN). Reaching the 51 cosponsor mark means the legislation, if it gets to the Senate floor, would have enough votes for final passage. While still 9 votes short of the 60 vote filibuster-proof majority need to ensure consideration on the Senate floor, political support for the FDA bill continues to grow.

Parallel legislation has been introduced in the House of Representatives and has 181 cosponsors, close to the 218 votes needed to ensure passage in the House.

It is expected that Senate Health Education Labor and Pensions Committee will mark up the Senate bill this summer. Parallel action in the House is also expected this summer.

Clinical Practice

ATS Signs Letter in Support of Medicaid GME Funding

This week, the ATS joined over 30 organization in a letter to the Centers for Medicare and Medicaid Services (CMS) opposing the proposed policy to end federal Medicaid payments to support graduate medical education (GME) payments at teaching hospitals. In May, CMS issued a rule “clarification” that proposed eliminating Medicaid matching payments to support medical training activities. Prior to the proposed clarification, CMS had recognized and approved state support for GME payments. Implementation of the proposed clarification would result in significant cuts in funds for GME support.

Congress has responded, in part, to the clarification by issuing a 1-year moratorium on implementation of the rule. However, the medical community is pushing to have CMS retract the proposed clarification. The letter calls upon CMS to retract the proposed rule.



Points of Contact

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