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Submitted by G_Wiley on Mon, 10/10/2011 - 11:41

News

The Latest from Capitol Hill

Dale Dirks is NephCure's representative in Washington, DC. His office works with NephCure on a number of political initiatives, including the inaugural Advocacy Day. His office periodically gives NephCure and it's constituents updates on what's hot on Capitol Hill. Here's the latest...

Leading up to the September 30^th end of fiscal year (FY) 2011 and the October 1^st beginning of fiscal year 2012, Congress continues its struggle to move annual appropriations bills. Although legislators must approve a stop-gap measure (continuing resolution—or CR) before the end of next week to keep the government operating, it is not yet clear how it will be achieved. A bill to temporarily extend the current level of funding for most federal programs through November 18^th was passed this week by the House of Representatives but the Senate will likely reject it because of its provisions related to disaster relief.

The House Appropriations Committee and the full House of Representatives have suspended work on individual appropriations bills, and is likely preparing for a package which rolls all or most of the 12 funding bills into an omnibus bill that will be considered en block. The House leadership and the committee are finding it difficult to satisfy its more conservative members. The conservatives believe that the spending measures—even though they comply with the recent bipartisan debt ceiling deal—are too generous.

In the meantime, the Senate Appropriations Committee has been grinding through its individual measures and has considered several of its bills in the last few weeks. Of specific importance to the NephCure Foundation, the committee finished work on its fiscal year 2012 Labor-HHS-Education bill on September 21^st, and reported it to the full Senate. This bill will serve as the basis for the Senate’s negotiating position when legislators ultimately work to finalize the fiscal year FY 2012 appropriations process.

The FY 2012 Labor-HHS-Education appropriations bill reported by the Senate Appropriations Committee includes the following funding levels compared to FY 2011:

An overall discretionary funding level of $158 billion, a decrease of $308 million.
$30.5 billion for the National Institutes of Health, a decrease of $180 million.
$6.22 billion for the Health Resources and Services Administration, a decrease of $50 million.
$7.06 billion for the Centers for Disease Control and Prevention, an increase of $175 million.
$3.4 billion for the Substance Abuse and Mental Health Services Administration, a decrease of $27 million.
$372 million for the Agency for Healthcare Research and Quality, level funded.
$68.4 billion for the Department of Education, an increase of $80 million.

Of specific interest to the NephCure Foundation, the bill includes the following:

Centers for Disease Control and Prevention

$777.987 million for the National Center for Chronic Disease Prevention and Health Promotion, an increase of $4 million over the FY11 funding level, and $52.78 million above the president’s request.

$2.093 million for Chronic Kidney Disease, level with the FY11 funding level.

National Institutes of Health

$1.722 billion for the National Institute of Diabetes and Digestive and Kidney Diseases, a decrease of $20.179 million below the FY11 funding level, and $65.9 million below the president’s request. The Committee report accompanying the bill includes the following recommendation:

Glomerular Diseases.—The Committee recognizes the recent progress made in understanding glomerular diseases, such as focal segmental glomerulosclerosis [FSGS], including the discovery of specific genetic factors which make African Americans five times more likely to develop FSGS than Caucasians. The Committee urges NIDDK to continue to support research on glomerular diseases and collaborate with NIMHD to expand research on the impact these diseases have on minority populations.

$272.650 million for the National Institute on Minority Health and Health Disparities, an increase of $62.937 million over the FY11 funding level, and $58 million above the president’s request. The Committee report accompanying the bill includes the following recommendation:

Glomerular Diseases.—The Committee notes that African Americans are five times more likely to develop glomerular diseases, such as focal segmental glomerulosclerosis [FSGS], than Caucasians. The Committee urges NIMHD to collaborate with NIDDK on this important issue.

$582.326 million for the National Center for Advancing Translational Sciences (NCATS).

NCATS will house several programs that are currently administered by and/or funded through NCRR, NHGRI or OD. They include Clinical and Translational Science Awards [CTSAs], Therapeutics for Rare and Neglected Diseases [TRND], Rapid Access to Interventional Development, the Office of Rare Diseases Research [ORDR] and the NIH-FDA Regulatory Science Initiative.

$20 million for the Cures Acceleration Network.

In addition, the Committee includes $20,000,000 to create the Cures Acceleration Network [CAN], which was authorized in the Patient Protection and Affordable Care Act. The Committee believes this program offers exciting potential to help speed the translation and application of promising new treatments for diseases. CAN is authorized to make grants to biotech companies, universities and patient advocacy groups to target new discoveries that have shown potential at the laboratory level but have not advanced far enough to attract significant investments from the private sector. Specifically, CAN will focus on funding the development of “high need cures,” which are defined as drugs, biological products or medical devices that the NIH Director determines to be a priority “to diagnose, mitigate, prevent, or treat harm from any disease or condition, and for which the incentives of the commercial market are unlikely to result in its adequate or timely development.” CAN is also intended to reduce the barriers between laboratory discoveries and clinical trials for new therapies and facilitate FDA review for the high need cures funded by this initiative.

Two types of awards are authorized – grant awards and partnership awards, the latter of which require a $1 to $3 match. Up to 20 percent of the appropriated funds may be used to obligate funds through “other transactions,” which are funding agreements or mechanisms that are not grants, contracts, or cooperative agreements, and are intended to provide additional flexibility akin to that of the Department of Defense’s Defense Advanced Research Projects Agency [DARPA].

$1.439 billion for the Office of the Director, an increase of $272.1 million over the FY11 funding level, and $140.652 above the president’s request.

$537.811 million for the Common Fund, a decrease of $5.21 million below the FY11 funding level, and $19 million below the president’s request.

The committee report accompanying the bill includes the following recommendation:

Global Rare Diseases Patient Registry and Data Repository.—The Committee commends NIH for its plans to develop the Global Rare Diseases Patient Registry and Data Repository [GRDR]. The Committee understands that a pilot program of the GRDR will include the creation of an infrastructure for an Internet-based platform to aggregate de-identified patient data from existing and newly established rare diseases registries and the development of a web-based template to allow any patient group to establish its own patient registry. The purpose of this pilot program is to develop a resource for patient support organizations and the scientific community, academic centers and industry in the United States and globally to mine the de-identified, aggregate data for various medical research studies, including clinical trials. The Committee encourages NIH to consider Duchenne muscular dystrophy and glomerular disease for inclusion in the pilot program.