Open Public Meeting - Human Bone Allograft
August 2, 2000 - Slide Presentation
Overview of the History of FDA Regulation of Bone as a Tissue
Antonio Pereira, M.D.
Medical Officer
Human Tissue Program
CBER, FDA
CBER-Important Dates
1902 - Biologics Control Act
requires the purity and safety of serums, vaccines and similar products
CBER-Important Dates
1944 - PHS Act
- Section 351(a): a biological product as "any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man"
- Section 361(a): "regulations.necessary to prevent the introduction, transmission or spread of communicable diseases."
CBER-Important Dates
- 1972 - Regulations of Biologics is transferred from the National Institute of Health to the Food and Drug Administration
- 1987 - The Center for Biologics Evaluation and Research (CBER) is formed after reorganization of the Center for Drug Evaluation and Research (CDER)
Human Tissue Regulation - 1990
- 1990's reports to the CDC about transmission of HIV through fresh frozen bone transplants
- 1991 Public Health Work Group recommended Federal development and publications of standards or guidance on donor screening, testing and tracking procedures to prevent transmission of infectious disease
Human Tissue Regulation - 1993
- Reports of importation of human tissue not properly screened and tested for HIV and Hepatitis
- Hearing on appropriate oversight for human tissue banking before the U.S. Senate Subcommittee on Regulation, Business Opportunities and Technology of the Committee on Small Business, held on October 15, 1993
Recommendations
- Persons involved in human tissue banking advocated that legislation setting forth regulatory requirements for human tissue banking be passed
- Public Health Work Group recommended Federal agencies proceed as "expeditiously as possible" to reduce the risk of transmission of infectious disease by human tissue transplantation
Interim Rule: Human Tissue Intended for Transplantation
- Published on December 14, 1993 and effective immediately
- Required screening and testing for HIV and Hepatitis B and C of all human tissue intended for transplantation
- Under Authority of section 361 for the prevention of spread of communicable disease
- Included "conventional" banked tissue, i.e., skin, bone, and eye
- Excluded vascularized organs, human milk, reproductive tissue and bone marrow
- Excluded products regulated as drugs, biological or medical devices
- Focused on the prevention of transmission of communicable disease
Interim Rule
"Tissues that are processed or stored only in ways to prevent transmission of infectious disease and to preserve clinical usefulness will be covered by the regulation"
"Tissues whose structure or functional characteristics have not been changed through processing or other techniques would be covered by the regulation"
Final Rule - 21 CFR Part 1270
- Published on July 29, 1997 after review of comments and public meetings/workshops
- Defined Human Tissue as: any tissue derived from a human body that,
- is intended for transplantation to another human for the diagnosis, cure, mitigation, treatment, or prevention of disease
- is recovered, processed, stored or distributed by methods that do not change tissue function or characteristics
Bone Allografts - (as of August 2, 2000)
- Fall within the scope of the Final Rule on Human Tissue Intended for Transplantation
- Provided that:
- are not processed by methods that change tissue function or characteristics
- are not regulated as drugs, biologics or devices
- are not combinations of bone allografts with a product regulated as a drug, biological or device
Proposed Approach for the Regulation of Human Cellular and Tissue-Based Products
- Tiered approach based on Public Health Risk
- Degree of manipulation and homologous use (amongst others ) will determine degree of regulation needed to assure safety and efficacy of human bone allografts products
" I wholly disapprove of what you say- and will defend to the death your right to say it"
Voltaire (?)
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