Human Tissue Task Force recommends biennial inspection for high-risk HCT/Ps.(Inspections)

FDA could conduct up to 484 inspections of makers of high-risk human cells, tissues, and cellular and tissue-based products (HCT/Ps), under fiscal 2007 resources, thus providing coverage to about 1/4 of the estimated 2,000 establishments of this type in the U.S.

According to the Center for Biologics report of its Human Tissue Task Force (HTTF) Report, FDA was recommended to conduct biennial inspection coverage of all establishments, triennial inspection coverage of other registered establishments, prompt re-inspection of violative establishments, and prompt compliance/enforcement review, support, and action against violative establishments.

The report also covered partnering, leveraging, education and outreach. It stated: "FDA is not the only entity with an interest in tissue safety. Federal and state partners, industry associations, and the industry itself have important roles and responsibilities in protecting and advancing public health by having a safe supply of tissue available."

The report recommended that partnering, leveraging, education, and outreach activities, could expand, but such expansion would require additional resources. Such activities could enable: improvements to our communication network with state and federal regulatory partners, sharing of information, and greater knowledge of industry operations and clinical practices. Additional resources could also allow enhanced communication with academic and professional organizations.

HTTF is a collaborative effort among those FDA components involved in tissue safety, including CBER, the FDA Office of Regulatory Affairs and the Office of the Commissioner. It was established in August 2006 as part of FDA's efforts to evaluate and, where needed, strengthen its risk-based system for regulating human cells, tissues, and cellular and tissue-based products which went into effect in the early part of 2005.

The task force is chaired by David Elder, Director, Office of Enforcement, ORA, and Celia Witten, M.D., Director, Office of Cellular Tissue and Gene Therapies, CBER.

The primary goal of the HTTF was to assess challenges that had occurred in implementation of the new system and to identify any additional steps needed to further protect the public health by preventing the transmission of communicable disease while assuring the availability of safe products.

In the area of adverse event reporting and analysis the HTTF found that the following recommendations could be implemented with current resources:

* Enhancing the investigation, classification, analysis and trending of adverse reaction reports;

* Continuing interactions with outside experts to provide scientific input and assistance for improving our processes in adverse reaction classification, review and analysis;

* Coordinating with CDC regarding the proposed Transplantation Transmission Sentinel Network (TTSN) project to assure that the TTSN complements FDA's existing surveillance system; and

* Sponsoring a workshop on tissue processing, inviting health care providers, scientists and industry to share knowledge and experiences regarding technologies and methods to enhance tissue safety. With additional resources,

these recommendations could be implemented:

* Expanding MedSun Cell/Tissue Pilot Project. Over 30 hospitals currently contribute to the tissue module of this passive safety surveillance program. Additional facilities continue to express interest. CBER assists CDRH and its contractor in the orientation program for newly participating facilities;

* Assuring successful IT system development and data migration for the replacement of the current adverse reports database with a professionally developed Oracle-based system; and

* Expanding collaborations with CDC and other agencies for the design and implementation of active tissue safety surveillance and other enhanced approaches. Two key potential collaborations with CDC would include the Transplantation Transmission Sentinel Network (TTSN) and the National Healthcare Safety Network (NHSN, formerly the NNIS).

Regarding the science of tissue safety, the report recommended that CBER "should initiate a tissue microbiology program through recruitment and support of a scientist with suitable expertise who will devote his/her effort to tissue safety."

The report added: "As this program is developed, it should be part of the CBER managed research program, and planning and implementation would be accomplished with academic and industry input and collaboration to leverage and enhance existing resources. The microbiologic expertise and capacity should also be structured to be useful to other program components, for example blood and vaccines. Achieving these goals fully will require additional time, planning, and human and financial resources."

By Joseph Pickett Managing Editor

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