CBER Presentation
FDA and Tissue Regulation
Celia Witten, Ph.D., M.D.
Office Director, OCTGT, CBER, FDA
World Health Organization
June 7-9, 2006
Geneva, Switzerland
PATIENT SAFETY: EVERYONE'S GOAL
Outline
- Development of FDA Regulations and Guidance
- Working with Professional Organizations
LEGAL FRAMEWORK
- Constitution
- Statutes
- Regulations
- Guidance
STATUTES
- Public Health Service Act
- licensing provisions
- prevent communicable disease
- Federal Food, Drug and Cosmetic Act
- Other Statutes
- e.g. Administrative Procedure Act
- Federal Advisory Committee Act
RULEMAKING AND POLICY: BASIS FOR REGULATORY DECISIONS
- Rule-" an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy"
- Has binding effect
- We create rules under statutory authorities (PHS Act and FDC Act)
GOOD GUIDANCE PRACTICES
(Title 21 Code of Federal Regulations (CFR) 10.115(a))
- GGP's are FDA's policies and procedures for developing, issuing, and using guidance documents
- Purpose-to make our procedures clear to public
- Regulated persons may chose an alternative approach that complies with laws and regulations
GOOD GUIDANCE PRACTICES
What is a Guidance Document? (21 CFR 10.115(b))
- A document prepared for FDA Staff, applicants/sponsors, and public that:
- Describes FDA's interpretation of or policy on a regulatory issue; or
- Relates to
- The design, production, labeling, promotion, manufacturing, and testing of regulated products;
- The processing, content, and evaluation or approval of submissions; and
- Inspection and enforcement policies
Tissue Rules
- 21 CFR Part 1270 - Human Tissue Intended for Transplantation
- 21 CFR Part 1271- Human Cells, Tissues, and Cellular and Tissue-Based Products
TISSUE GUIDANCE
- Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P's) - 11/30/2005
- Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P's) 11/12/2004
- Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation 3/8/2002
- Draft Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 5/20/2004
- Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 6/14/2002
FDA is only one piece of the puzzle...
FDA / PROFESSIONAL ORGANIZATIONS
- Public input and dialogue on FDA regulations and guidance
- Professional standards
- Can be referred in a guidance
- How to comply with regulations
- Areas not addressed by regulations or guidance
FDA/Professional Organizations: Communication
- Liaison Meetings
- Dissemination of FDA Policy
- Communication by industry of issues of concern
- Educational Programs
- Public workshops
- Participation at Public Advisory Committee Meetings
EXAMPLES
- EBAA/AATB - Q's and A's on GTP's
- FDA liaison membership on committees (AATB Standards Committee, Medical Advisory Committee, Reproductive Council, EBAA Medical Advisory Committee)
- Participation in District Office Inspectors Training
- ISCT/FDA workshop on Somatic Cell Therapy
- Workshop participation (examples)
- Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair (8/2000)
- Unrelated Allogeneic Cord Blood Banking and Transplantation Forum (8/2000)
- FDA Liaison to Unified Donor History Questionnaire Task Group
CONTACT INFORMATION
Celia Witten, PH.D., M.D.
Office Director, OCTGT
CBER/FDA
1401 Rockville Pike (HFM 700)
Suite 200N
Rockville, MD 20852-1448
301-827-5102