Why is this initiative necessary?
The number of human tissue transplants has increased from approximately 350,000 in 1990, to more than 1,000,000 annually, and this number will likely increase in the future. A single donor may yield more than 100 tissue products. Consequently, many individuals are at risk when communicable disease risk assessments and controls are inadequate.
FDA is implementing a new, risk-based approach to assure the safety of the human cells, tissues, and cellular and tissue-based products (HCT/Ps) involved in these human tissue transplants. This initiative will allow FDA to address issues related to safety and effectiveness of a rapidly growing industry.
Over the past decade, advancing technology and improved techniques have expanded the therapeutic uses of bioengineered and innovative cells and tissues. However, the clinical safety and effectiveness of many of these advances must be addressed. Tissue transplants have recently caused multiple cases of bacterial and fungal infections, sometimes resulting in severe illness and death. In addition, emerging infectious disease transmission from donors remains a concern. Tissues may also become contaminated while they are recovered and processed. To ensure the safety of HCT/Ps, FDA must carefully assess new tissue technologies, ensure industry compliance with regulatory standards, conduct adverse event analysis and respond to outbreaks of infection associated with HCT/Ps.
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How does this initiative support Executive Branch public health priorities?
The activities in this initiative directly support the Secretary's vision for transforming health care. New HCT/P products hold the potential of providing important therapies for cancer, AIDS, Parkinson's disease, hemophilia, anemia, diabetes, and other serious conditions. Many of these products are also critical to our preparedness for war and terrorism. Therefore, the initiative also supports the Administration priority of securing the homeland.
What are the risks of not proceeding with the initiative?
Without this initiative, the American public risks an increase in preventable transmission of new and emerging infectious diseases. Efforts to prevent and detect dangerous microbial contaminants during tissue manufacturing will also stall. This will undermine the confidence of patient and medical providers in the products and practices of the tissue industry, and limit innovation and the availability of promising new products.
What activities will these funds support?
FDA is requesting resources to implement the new risk-based comprehensive approach for assuring the safety of HCT/Ps. These funds will support:
- Detection, analysis and response to actual or potential disease transmission.
- Improved IT systems and procedures to support investigation, analysis and follow-up on adverse reaction reports.
- Outreach to industry and education for the medical community and the public about human tissue safety.
- Research, review and pre-licensure inspections for products that require Investigative New Drug and Biologic License Applications
- Training of FDA investigators and staff.
- High quality inspections and compliance activities for manufacturing and processing facilities.
What results will FDA achieve?
With these resources, FDA will:
- Conduct 75 additional tissue inspections and thereby significantly increase coverage among the approximately 2,000 registered firms.
- Ensure that tissue establishments demonstrate clinical safety and efficacy of their products and that there is appropriate review of HCT/Ps.
- Prevent injuries and death by rapidly detecting, analyzing and responding to adverse events involving tissue contamination.
- Rapidly review, track, and analyze tissue deviation reports submitted to the Agency by HCT/P manufacturers.
- Develop and issue program and policy documents for tissue inspections and imported tissue, as well as new regulatory procedures for compliance actions.
- Develop and issue guidance for industry on a broad array of topics related to donor eligibility and good tissue practices.
 FDA's human tissues program covers transplantable tissues to include bone, skin, corneas, tendons, ligaments, and heart valves. FDA's regulatory program does not include certain bone marrow or whole organs for transplant. Whole organ transplants involve the replacement of organs--the kidneys, liver, heart, lungs, pancreas, or intestine. These are managed under separate programs in the Health Resources and Services Administration of the Department of Health and Human Services.