Nationwide "blitz" by FDA regulatory office finds no significant problems in tissue recovery companies

Transplant News,  July, 2007  by Jim Warren

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A nationwide "blitz" of more than 150 US tissue recovery companies conducted by federal regulators from October 2006 through March 2007 found there are no significant industry wide problems in the recovery of hums tissues used for transplantation.

The blitz, which was conducted by the US Food and Drug Administration's Office of Regulatory Affairs (ORA) in response to recent scandals involving tissue processing companies, targeted companies that recover human tissues, including tendons, ligaments, bone and other musculoskeletal tissue. The FDA was forced to shut down two tissue processing companies in 2006 - Biomedical Tissue Services (BTS) of New Jersey, and Donor Referral Services (DRS) of Raleigh, NC.

The report was issued by FDA's Human Tissue Task Force (HTTF), an intro-agency group assembled in August 2006 to evaluate the effectiveness of the agency's tissue regulations.

Based on data from the blitz, HTTF reported that nearly all 153 recovery companies evaluated were in substantial compliance with FDA's comprehensive risk-based tissue regulation that went into effect in 2005. While some deviations from the regulations were identified, no major inaccuracies or deficiencies were found that could put tissue recipients at risk.

"The results, particularly of the blitz, show that FDA's new tissue regulations help keep human tissue safe," said Jessie Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research (CBER). "The work of the HTTF and FDA has provided valuable information about tissue recovery firms, our status on tissue safety, and important steps that should be taken to enhance the safeguards already in place."

Goodman told the Associated Press the blitz of inspections came after he read press reports last year on how little government oversight there was of the industry.

Despite the overall positive findings, the HTTF issued several recommendations on how to enhance tissue safety activities. FDA said it plans to use the information to better understand and oversee industry practices and to develop or revise guidance documents, regulations and inspection strategies.

There are more than 2,000 active cell and tissue establishments registered with the FDA. This year the agency said it intends to conduct an additional 484 inspections. The task force recommended that all tissue establishments performing manufacturing steps considered to represent the highest potential risk for disease transmission be inspected every two years and all other establishments every three years.

"The recommendations of the task force will help us provide greater assurance of tissue safety," ORA Associate Commissioner Margaret O K Glavin said. "The collaboration between CBER and the Office of Regulatory Affairs through the HTTF is a model that served us particularly well and will be continued."

The other HTTF recommendations include:

*Inspection and Compliance Activities: All high-risk tissue establishments should be inspected every two yeasr; all other establishments should be inspected every three years; establishments committing violations should be promptly reinspected; and there should be a prompt compliance/enforcement review, support, and action against establishments committing violations.

*Partnering, Leveraging, Education and Outreach: FDA is not the only entity with an interest in tissue safety. Federal and state partners, industry associations, and the industry itself have important responsibilities in protecting and advancing public health by having a safe supply of tissue available. The ORA is continuing to survey several key states to determine appropriate contacts, authorities and interest in partnership opportunities. A model partnership agreement to be used with the states is being developed with the most likely beneficiaries being states with the most highly developed regulatory programs in existence. Upon identification of appropriate opportunities, ORA will fund or seek funding for the agreements.

The FDA will sponsor a workshop on tissue processing and microbiology for industry, implanting surgeons and academia to explore public and private partnerships and to develop and share best practices for reducing the risk of disease transmission.

*Adverse Reaction Reporting and Analysis: Coordinate with the Centers for Disease Control and Prevention (CDC) regarding the proposed Transplantation Transmission Sentinel Network (TTSN) to assure that the TTSN complements FDA's existing surveillance system. Expand the MedSun Cell/Tissue Pilot Project. Over 30 hospitals currently contribute to the tissue module of this passive safety surveillance program. Expand collaborations with the CDC and other agencies for the design and implementation of active safety surveillance and other enhanced approaches.

FDA received expert advice that is being used to refine the activities of the agency's multidisciplinary Tissue Safety Team, formed in 2004 to evaluate adverse reaction reports and other tissue safety issues. CBER has further strengthened its communications with the CDC. FDA also intends to expand its use of voluntary adverse reaction reporting.