Stem Cell Therapeutic and Research Reauthorization Act, HR 6081
H.R. 6081 is expected to be considered on the House floor on Wednesday, 9/29/10, under a suspension of the rules, requiring a 2/3’s majority vote to pass. Rep. C.W. Bill Young (R-FL) introduced H.R. 6081 on 8/9/10, and it was referred to the Committee on Energy and Commerce.
- H.R. 6081 would reauthorize the C.W. Bill Young Cell Transplantation Program, which includes the National Registry for adult donors of bone marrow, peripheral blood [adult] stem cells, and umbilical cord blood units, as well as the National Cord Blood Inventory (NCBI) for an additional 5 year period;
- The current authorization expires at the end of FY10.
In 2005, Congress approved the Stem Cell Therapeutic and Research Act of 2005, which facilitated the use of umbilical-cord-blood stem cells in biomedical research and in the treatment of disease. Cord-blood stem cells, collected from the placenta and umbilical cord after birth without doing harm to mother or child, have been used in the treatment of thousands of patients suffering from more than 60 different diseases, including leukemia, Fanconi anemia, sickle cell disease, and thalassemia.
- Researchers also believe cord-blood stem cells may have the capacity to be differentiated into other cell types, making them useful in the exploration of ethical stem cell therapies for regenerative medicine.
Specifically, H.R. 6081 would do the following:
- Remove the 150,000 cap on cord blood units to be made available for transplant;
- Extend the term of initial and contract extensions from three to five years, making it easier for banks to engage in long-term relationship building with birthing hospitals;
- Require cord blood banks to establish a plan for increasing cord blood unit collections and/or expand the number of collection sites with which they work;
- Require cord blood banks to provide a plan for becoming self-sufficient;
- Clarify the minimum timeframe for maintaining NCBI cord blood units on the National Registry;
- Correct the definition of “first-degree relative” to exclude a parent;
- Authorize $23 M to be appropriated for fiscal year 2011 through fiscal year 2014 and $20 million for fiscal year 2015 for the NCBI (when combined with the funding levels for the program, the overall bill does not increase federal spending);
- Allow Health Resources and Service Administration (HRSA) to allocate funds appropriated in the following year, as needed, for both the program and the NCBI;
- Update the annual reporting requirements for the program;
- Enhance the studies, demonstration programs, and outreach projects related to cord blood donation and collection to include exploring innovative technologies, novel approaches, and expanding the number of collection sites;
- Update the confidentiality language that applies to adult donors to make it consistent with the requirements for cord blood donors and existing federal and state privacy laws;
- Require a GAO report to review studies, demonstration programs, and outreach efforts for the purpose of increasing cord blood unit donation and collection for the NCBI to ensure high-quality and genetically diverse inventory of cord blood units