2012-04-19

ASH Committee on Government Affairs Visits Congress to Discuss Research Funding and Drug Shortages
Following its March 21 meeting in Washington, DC, the ASH Committee on Government Affairs visited more than 40 congressional offices to explain to Members of Congress and their staff the impact of potential cuts in funding to the National Institutes of Health (NIH) on research to find cures and treatments for patients with serious hematologic diseases. Committee members also discussed the topic of drug shortages with congressional offices. Read more.

ASH Submits Testimony to House and Senate Appropriations Committees: Asks for $32 Billion for NIH in FY 2013
On March 20, the Labor-HHS-Education Appropriations Subcommittee in the House of Representatives began hearings concerning fiscal year (FY) 2013 funding. NIH Director Dr. Francis Collins and officials from the various institutes and centers at NIH testified on behalf of the fiscal year (FY) 2013 budget request for NIH. ASH submitted written testimony to both the House and Senate Subcommittees in support of at least $32 billion in funding for NIH in FY 2013. Read more.

ASH Submits Comments to the Senate on Draft Prescription Drug Shortage Legislation; Supports Early Notification System
ASH submitted comments to the Senate Committee on Health, Education, Labor, and Pensions (HELP) on draft legislation concerning prescription drug shortages. The draft bill is similar to other congressional legislation ASH has endorsed and would create a mandatory "early warning system" that requires manufacturers to provide early notification to FDA of a discontinuance or "meaningful disruption" of drugs which are life-supporting, life-sustaining or used in the prevention of a debilitating disease or condition. ASH offered a number of recommendations to strengthen the legislation. Read more about ASH's comments and information about the status of additional hematologic drug shortages, ASH advocacy efforts, and resources for physicians dealing with shortages.

ASH Identifies Unmet Needs for Clinical Translation of Cell-Based Therapies
In response to the NIH Office of Strategic Coordination Request for Information "Defining Unmet Needs for Clinical Translation of Cell-Based Therapies," ASH has submitted comments urging the NIH to ensure that resources adequately meet the needs of basic discovery, translational and clinical applications of this evolving technology. ASH also recommended that the new Center for Regenerative Medicine should coordinate efforts that focus on studying both the potential efficacy and the safety of cell-based therapies, including patient-specific database registries for effectively tracking outcomes and adverse events of subjects receiving cellular reagents. In addition, efforts should be directed towards developing a consensus around the utility of animals and animal models to test efficacy and safety of cellular products.

Gary H. Gibbons, MD Selected to be Director of the National Heart, Lung, and Blood Institute
NIH Director Francis Collins, MD has announced the selection of Dr. Gary H. Gibbons to be the new Director of the National Heart, Lung, and Blood Institute (NHLBI). Dr. Gibbons is expected to join the NIH leadership team this summer. Until his arrival, Dr. Susan Shurin will continue to lead NHLBI as the Institute's Acting Director. She will then return to her position of Deputy Director of the Institute. Read more.

IOM Releases Report on Transforming U.S. Clinical Trials Enterprise
The Institute of Medicine (IOM) has released a prepublication workshop summary, "Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary," which summarizes a workshop hosted by the IOM's Forum on Drug Discovery, Development, and Translation. The workshop was part of a series that has been convened by the Forum since 2009 to consider challenges facing the U.S. clinical trials enterprise and to engage stakeholders in an open discussion of potentially transformative strategies to improve the efficiency and effectiveness of clinical trials.

Find the Latest on NIH Grants Policies and Activities in the NIH Extramural Nexus
The NIH Extramural Nexus provides regular updates on NIH grants policies and activities that impact the entire research community. Recent posts include information on NIH's new web-based tutorial on the revised financial conflict of interest regulations, information on the 2012 NIH regional seminars, and whether it matters where your grant application is reviewed. Read more.