U.S. Food and Drug Administration
Performance Plan
2002
To ensure the safety of the nation's blood supply and human tissues for transplantation.
| Maintain the percentage of plasma fractionator establishments in compliance with CGMPs at 80%. |
Blood: FDA is responsible for the safety of the United States' blood supply. The blood supply is critical to the nation's health care system, and the United States has the safest blood supply in the world. Each year approximately 14 million units are drawn from volunteer donors for use in more than 3.5 million Americans.
The AIDS epidemic in the mid-1980s prompted a critical concern about blood safety, which was exacerbated by the subsequent identification of other blood hazards (such as Hepatitis A, B, and C and transmissible spongiform encephalopathies, including "mad cow" disease).
Tissues: All human tissue and tissue-related products have the potential to transmit communicable disease, and FDA believes every reasonable effort should be made to prevent the transmission of disease, while ensuring the continued availability of safe human tissue products. Of particular concern are HIV, Hepatitis B, and Hepatitis C. Due to reports of unsafe practices in select numbers of tissue banks, FDA issued an interim rule that required certain minimum infectious disease screening and testing standards and provided for the inspection of tissue banks and the destruction of unsafe human tissue.
FDA announced Reinventing the Regulation of Human Tissue and A Proposed Approach to the Regulation of Cellular and Tissue-based Products in February 1997. This risk-based, tiered regulatory framework addressed fragmented policies and regulations for tissues and cellular products and linked the level of regulation to the level of risk involved.
Blood: The blood safety system established by FDA consists of five-layers that begin at the blood collection center and encompasses the manufacturers and distributors of blood products. These are: 1) Donor screening to determine suitable donors; 2) Testing for blood-borne agents such as HIV, hepatitis, and HTLV-I; 3) Requiring blood establishments to keep a current list of deferred donors; 4) Quarantining blood products until the products have been thoroughly tested and the donation records have been verified; and 5) Requiring blood establishments to investigate any breaches of these safeguards and to correct any system deficiencies that are found.
In the United States today, licensed establishments include more than 1,000 donor centers that collect, process and distribute blood and blood products in interstate commerce under federal regulations. FDA investigators across the country conduct inspections of all licensed blood establishments each year. During the inspection, investigators monitor donor screening; blood testing, labeling, storage, and handling; and record keeping and other manufacturing practices.
FDA initiated a Blood Action Plan in July 1997 to increase the effectiveness of its scientific and regulatory actions, and to ensure greater coordination with other federal agencies.
The Blood Action Plan involves several initiatives: updating and reinventing the blood regulations; addressing emerging infectious diseases; ensuring compliance of plasma fractionation establishments; blood donor/recipient notification and lookback; and FDA emergency recalls affecting blood safety response procedures.
Tissues: In consultation with the tissue industry, FDA proposed implementation of a four-tiered approach to tissue regulation:
1. Communicable disease controls. The Agency would set screening and testing requirements and recommendations, but in many cases would not require individuals to file information with the Agency. All uses of tissues (except removing and re-implanting tissue in the same patient) would be subject to some infectious disease controls.
2. Handling and processing. All uses of tissue products (except removing and reimplanting tissue in the same patient) would be subject to handling and processing controls to prevent contamination.
3. Clinical safety and effectiveness. Tissue products that are manipulated such that their biological characteristics or relevant functions are altered, would be subject to more comprehensive regulatory requirements than other tissue products, including submissions of clinical trial data demonstrating safety and effectiveness.
4. Registration and listing. The Agency would require that all tissue product processing facilities register with the Agency and list their products via a simple electronic system.
Blood: The blood supply is essential to the nation's health care system. History has shown that emerging infectious diseases such as HIV/AIDS can be transmitted through blood transfusions. Unknown or emerging agents that may not be inactivated or removed during processing pose the greatest threat to the blood supply. If we fail to successfully regulate blood, the public health consequences could be alarming.
Tissues: Failure to fully implement the Tissue Action Plan increases the chances of the transmission of infectious diseases through tissue products.
Blood: To date, FDA has:
FDA has been successful in many areas in the Blood program; however, there is still work to be done. FDA needs to establish a process for identifying and reacting to the constantly changing new threats to the blood supply, such as Creutzfeldt-Jakob Disease ("mad cow" disease).
FDA still needs to:
Tissues: FDA published the proposed rule, Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products: Inspection and Enforcement, on January 8, 2001. On January 19, 2001, FDA published the final rule, Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing.
FDA still needs to: