Tissue Policy Group (TPG) Update
TPG October meeting focused on agenda for the next two years
During the TPG in-person meeting in October, the focus will be determining the Congressional outreach agenda for the next two years. A key component of that agenda will likely be the advancement of policies related to how the Food and Drug Administration (FDA or Agency) responds after the 36-month enforcement discretion period ends.
While the FDA clarified in its December 2017 update to the final guidance document that the 36-month enforcement discretion applies to both allografts and autografts, the TPG remains concerned with how the FDA intends to assist tissue banks at the close of the enforcement period. Specifically, the TPG requests that the Agency convey to tissue banks the overall process it will follow subsequent to the close of the enforcement discretion period, which is slated to end in November 2020.
As part of that plan, the AATB urges the FDA to focus on three key processes: (1) provide a non-punitive way to allow tissue banks to come into compliance, (2) clearly delineate the products or claims which are of concern to the Agency, and (3) detail the process by which patients have continued access to products while tissue banks come into compliance. Our legislative agenda will likely include a plan to ensure Congressional oversight or outreach to ensure the Agency considers these processes.
California State legislation affecting HCT/Ps updated
Last year, the state of California passed a bill (SB 512), which would, among other things, require a licensed health care practitioner who performs a stem cell therapy to communicate to his or her patient specified information regarding the provision of stem cell therapies. Unfortunately, due to drafting issues, all 361 HCT/Ps were inadvertently covered within those requirements. This year, the AATB is working to correct that error. In late February, SB 1495 was introduced, which would make the necessary corrections. After the appropriate volleying of the bill between the House and Senate, the Governor signed the bill on September 14. It will go into effect as of January 1, 2019.
FDA issues report on HCT/P deviation report
Recently, the FDA Center for Biologics Evaluation and Research issued its FY17 deviation report. Focusing solely on 361 HCT/Ps, the report breaks down deviation reports into two categories – cellular and tissue. For both cellular and tissue HCT/Ps, the largest number of reports focused on receipt, pre-distribution, shipment, and distribution. However, the second leading cause of reports differed. For cellular HCT/Ps, the second leading cause for a deviation report related to processing and processing controls; for tissue HCT/Ps, donor eligibility.
AATB pleased with the AHRMM LUC Working Group final deliverable
For over a year, AATB has been participating in the Association for Healthcare Resource and Materials Management (AAHRM) Learning UDI Community (LUC) Workgroup, focused on medical devices containing HCT/Ps. Recently, the workgroup finalized and posted its educational document. The final document does not clearly indicate that any of the three issuing agencies should be solely used for HCT/Ps, despite the initial conversations that were leaning in that direction. AATB applauds the LUC’s efforts to appropriately capture HCT/Ps within the UDI and to retain all three options (e.g., HIBCC, ICCBBA’s ISBT-128, and GS1) for labeling these products.
AATB seeks further clarity from the VA
In July, the Senate confirmed Robert Wilkie as Veterans Affairs (VA) secretary. President Trump nominated Robert Wilkie, who is a Pentagon undersecretary, to lead the department after removing former VA Secretary David Shulkin. Previously, Wilkie's nomination was advanced by the Senate Veterans’ Affairs committee on a voice vote. Independent Sen. Bernie Sanders of Vermont, who was not in the room, requested to be recorded as a "no" vote. In preparation for his confirmation, last week, the Department asked Dr. Richard Stone to temporarily take over the reins of the Veterans Health Administration, shifting the previous administrator, Dr. Carolyn Clancy, to another position within the VA.
As part of Wilkie's confirmation process, Sen. Isakson, Chairman of the Senate Veterans' Affairs Committee, at the prompting of AATB and the AATB TPG, requested that the VA provide information to him regarding a recent VA solicitation which would limit the VA’s purchase of certain tissue products to those labeled with ICCBBA's ISBT-128. On September 12, the VA responded to this information, and the TPG will be discussing how best to follow up with the response.
Initial question: My understanding is that the VA recently opened a solicitation related to human tissue products, which would require that all products be labeled with ICCBBA’s ISBT-128. The Food and Drug Administration allows human tissue to be labeled with ISBT-128, as well as two other accredited issuing agencies. I have heard concerns that the VA’s proposal to limit its vendors to one labeling system could limit the types of tissue available to veterans. The tissue industry uses all three labeling systems, so limiting the VA’s options to just one will exclude many potential vendors, thus limiting choices for our veterans. Tissue is often required for critical procedures such as ACL reconstruction, treatment of burns (e.g., dermis, amnion), and bone reconstruction after trauma. Why is the VA limiting its labeling options in this manner? What has been the feedback from the tissue industry on this limitation? Can you keep me apprised of the implementation of this new policy, especially as it relates to access to all tissue products?
VA’s response: A has not limited labeling, but has rather set a preferred business requirement for ISBT-128 labeled human product as it covers the business requirements for tracking human tissue with a single distinct unique identifier. The coding standards GS-1 and the Health Industry Business Communications Council are not distinct and require lengthy, inefficient record chains to be maintained within VA to ensure quality product is supplied for patient care and to protect against fraud. VA would prefer to pay manufacturers for ISBT-128 labeled product similar to what has been proven to provide precise tracking of blood and corneas, protecting against the fraud and improper collections that have occurred recently within the human tissue industry. VA has the right to set business requirements and to promote efficient use of tax payer dollars as part of its fiduciary responsibility. VA has engaged extensively with tissue manufacturers.
AATB weighs in on pandemic legislation
Recently, the U.S. House of Representatives passed legislation to strengthen our nation’s response to natural and man-made public health emergencies. The Senate is poised to pass the legislation as well. Recognizing the value of tissue banks in assisting with certain disasters, AATB and the AATB TPG requested minor changes in the House and Senate legislation to appropriately acknowledge the contributions of tissue banks. Both the House and Senate drafts include the requested language. As such, while they still need to work out other differences in the two key bills, we fully expect the requested changes to be in the final law.