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May 7, 2007

2007

May 7, 2007

RESEARCH

Senators Support Increased NIH Funding
Mirroring similar action in the House last week, 48 Senators (at press time) sent a “Dear Colleague” letter to Sen. Byrd, (D-WV), Chairman of the Senate Appropriations Committee and Sen. Cochran (R-MS) Ranking Member, this week in support of increased funding for the National Institutes of Health (NIH). Sens. Kennedy (D-MA), Hatch, (R-UT), Dodd (D-CT) and Burr (R-NC) sponsored the letter, which requests a 6.7% funding increase for NIH from FY2008 through FY2010.

In the letter, the sponsors state, “If we are to improve the health of Americans and improve the quality of their longer lives, Congress must make FY2008 the beginning of an annual commitment by the Congress to provide adequate funding for health research.”

ATS President John Heffner, MD, sent a letter to all Senators requesting their sign-on to the “Dear Colleague” letter. The ATS Washington Office will keep members informed of efforts to increase NIH funding for FY2008 and will alert members when their action is needed to support this.

PEDIATRIC LUNG HEALTH

Pediatric Medical Device and Drug Testing Legislation Advances in Senate
Legislation to speed the development of medical devices designed for children and increase the number of drugs tested and labeled for children moved closer to Senate passage this week. The measures are part of larger legislation reauthorizing the Prescription Drug Fee User Act (PDUFA) called the Food and Drug Administration Revitalization Act (FDARA), S. 1082.

The Pediatric Medical Device Safety and Improvement Act, S. 830, offers incentives to manufacturers of medical devices for children, requires post-market studies of devices to ensure their safety and efficacy, and coordinates research efforts at the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ) and the FDA. The Best Pharmaceuticals for Children Act (BPCA) reauthorization bill, S.1156, reauthorizes the FDA’s pediatric drug incentive program, which grants manufacturers of drugs being tested for children an additional six months of patent exclusivity. Since enactment of the BPCA and in the late 1990’s, pediatric clinical trials have been completed in over 130 drugs and 115 drug labels have been changed to incorporate new pediatric information. Prior to enactment of this legislation, most drugs were not being tested for use in children.

The ATS joined with the American Academy of Pediatrics in sending a letter to Sen. Dodd (D-CT), this week supporting both the pediatric drug testing and medical device bills in order to oppose any weakening amendments to the measures. The Senate is expected to vote on FDARA this week, paving the way for enactment of these important child health measures into law. The pediatric medical device bill, H.R. 1494, is being sponsored in the House by Rep. Markey (D-MA). The pediatric drug testing bill is expected to be introduced in the House by Rep. Eshoo (D-CA) within the next week. The ATS Washington Office will alert members when their action is needed to support these bills as they moves towards passage in the Senate and action in the House.

 



Points of Contact

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