US Congress passes national CB program

By unanimous voice vote, the US Congress has finally passed legislation to create a national program of cord blood banking.  The provisions of this bill are summarized on this website under the news report of 24 May 2005.  The full text of H.R. 2520 and its Senate companion S.1317 can be read in the Congressional Record.

History of this legislation:

Thanks to lobbying by Dr. Pablo Rubinstein and the NY Blood Center, on 12 June 2003 (see old news reports) legislation was first proposed to establish a national program of public cord blood banks.  Dr. Rubinstein claimed that an inventory of 150,000 cord blood donations would be enough to supply the transplant needs of 90% of the American public.

On 24 July 2003, the House of Representatives introduced 2003 H.R. 2852, called the Cord Blood Stem Cell Act of 2003.  On 3 Oct 2003, the Senate introduced a companion bill 2003 S.1717.

Subsequently, this legislation became incredibly bogged down in rivalry between the NY Blood Center (NYBC) and the National Marrow Donor Program (NMDP), both of whom wished to control the national cord blood program.  The NY Blood Center even renamed their website "www.NationalCordBloodProgram.org".

To clarify these issues, on 23 Jan 2004 Congress commissioned an Institute of Medicine (IoM) study to make recommendations on the ideal structure of a national cord blood program.   The National Academy of Sciences proceded to assemble an IoM Committee and held a series of meetings on 2 June,  18-19 August,  29 Sept 2004, and 15 Dec 2004.

Meanwhile, between Jan 2003 and June 2004, the NY Blood Center and their ally Thermogenesis (Nasdaq: KOOL) spent $330,000 on lobbying, according to the US Senate Office of Public Records   (reported on this website Nov 2004).   Opponents of the NMDP managed to block the bill, H.R. 3034, which would re-authorize their budget.   During the same time period, the NMDP spent $860,000 on lobbying, according to the same data base.  In February and March of 2005, the NYBC lobbied Congress to introduce yet another set of Cord Blood Stem Cell Acts, H.R. 596 and S.681, which are replays of the 2003 legislation that triggered the IoM study.

Finally, the Institue of Medicine released their report, "Establishing a National Hematopoietic Stem Cell Bank Program", on 14 April 2005.  The IoM did not side with either the NYBC or the NMDP, but set a course down the middle.  The chapters of the IoM report are available on this website, linked to the news story of 14 April 2005. 

Consequently, on 24 May 2005, the NYBC and NMDP reached a compromise and the House of Representatives passed H.R. 2520, "The Stem Cell Therapeutic and Research Act of 2005".  The provisions of H.R. 2520 are itemized in the news report of 24 May 2005.  It reauthorizes the bone marrow budget of NMDP and establishes a cord blood program in parallel to the NMDP.  A companion bill, S.1317 was introduced to the Senate.

Fast forward to the present:

On 15 Dec 2005, the House Majority Leader submitted a "unanimous consent request" for the Stem Cell Therapeutic and Research Act of 2005.  After some debate, both H.R.2520 and S.1317 were passed on 16 Dec 2005 by voice vote.

Senate amendments to the original House bill:

Cord blood transplants are still not "licensed" by the FDA, but are given under an "investigational new drug" (IND) status.  In some cases, patients' insurance companies use this loophole to deny coverage for a CB transplant.  An amendment to H.R. 2520 requires the FDA to report on requirements for licensing cord blood units, within 90 days of the passage of the bill.

The Senate amendments also revise the existing Section 379 of the Public Health Services Act (42 U.S.C. 274k) to be consistent with the new requirements of H.R. 2520.   The bone marrow and cord blood programs will have parallel status and the umbrella organization above them will be called the C. W. BILL YOUNG CELL TRANSPLANTATION PROGRAM.

The Health Resources and Services Administration (HRSA) must release a Request for Proposal (RFP) for the initial establishment of the cord blood program.  In principle, all of the following may be competed:

1. Participating Cord Blood Banks
2. Bone Marrow Coordinating Center (this contract is currently held by the National Marrow Donor Program, or NMDP)
3. Cord Blood Coordinating Center
4. Single-Point of Patient Access (in case 2. and 3. are won by different organizations)
5. Outcomes DataBase
6. Office of Patient Advocacy

Starting in 2007, up to 5% of annual funds may be given to the Sibling Donor Cord Blood Program  at CHORI, as a demonstration program.

For the purposes of the program, a Qualified Cord Blood Bank is one that has the requisite accreditations, has established a confidential system of tracking donor ID and linkage to the mother, and encourages donation.

Funding for the program:

The actual funding of the program is dependent on the 2006 appropriations for the US Dept's of Labor, Health and Human Services, and Education.  This has not yet been approved. 

On 16 Dec 2005, Senator Harkin testified that his subcommittee had appropriated $19.8 million over the past two years for the National Cord Blood Stem Cell Banking Program.  For fiscal year 2006, he and Senator Specter have requested $9.9 million.  However,  the conference committee has cut that down to $4 million, "meaning 3,900 fewer units of cord blood will be collected"  (at a cost of $1025 each).  Moreover, when Dept of Defense appropriations are made, there may be an additional 1% cut for all other federal programs. 

To be continued....