The Food and Drug Administration is working with ABC and the blood community to promote the most efficient use of apheresis plasma from unpaid volunteer donors for further manufacturing into life-saving derivatives, according to Jay Epstein, MD, director of FDA's Office of Blood Research and Review (OBRR) in the Center for Biologics Evaluation and Research (CBER). An ABC delegation including President Dave Green, President-Elect Susan Rossmann, MD, PhD, Chief Medical Officer Louis Katz, MD, and myself, met at the FDA White Oak campus yesterday with OBRR representatives to discuss these plasma requirements and other topics of interest to ABC members. In addition to Dr. Epstein, key members of the OBRR leadership team participated in the meeting.
While the meeting's focus was ABC's request for flexibility in our ability to use apheresis plasma optimally for either transfusion or further manufacture, ABC also requested that FDA reconsider variant Creutzfeldt-Jakob disease deferral criteria and consider less burdensome options for quality control testing of apheresis components. Based on the discussion, ABC is cautiously optimistic that activity on these issues will be forthcoming. This get-together closely follows the Oct. 30 meeting between FDA officials and the blood community, represented by ABC, American Red Cross, AABB, and the American Plasma Users Coalition (A-PLUS) on the same topics (see ABC Newsletter, 11/7/14).
In other news from Washington, two ABC members have reported the insertion of problematic language within Veterans Affairs (VA) hospital contracts. Many ABC members have the privilege of serving veterans by providing blood products to VA hospitals across the US. Unfortunately, a clause referencing the Service Contract Act (SCA) has been inserted into two blood operator contracts in recent months.
In brief, the inclusion of SCA language requires the blood center to increase wages, benefits, and record keeping to the extent that the additional cost alone may exceed the value of the entire VA contract. With the option of increasing prices to cover the increase ($1,000 toilet seats, anyone?) or eating the negative margin, blood centers are opting to continue providing needed blood products to our brave men and women without a contract.
ABC is working on your behalf here in Washington to fix this problem. If you are experiencing any SCA activity with your VA contracts, in addition to working with your local VA contractor, please send a short note to ABC describing your situation to email@example.com with the subject line "VA," including the SCA language and the impact of compliance to your center. We are working diligently to facilitate a solution with the US Department of Veterans Affairs and it will help us to have additional information on the prevalence and impact of the problem.
Remember, Washington matters!
Christine Zambricki, DNAP, CRNA, FAAN, Chief Executive Officer;CZambricki@americasblood.org