CBER Presentation

Printable Version

FDA Update: Regulation of Reproductive Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps)

ASRM Annual Meeting
10/22-26/2006

Jackie Neidinger, BS, CTBS
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research (CBER), FDA

Applicable FDA Requirements

  • Registration and listing if the establishment performs any manufacturing function and doesn't fit any of the 1271.15 exemptions
  • Donor eligibility (DE) required for donors of semen and oocytes if anonymous or directed
  • Good Tissue Practices - only
    • 1271.150(c) manufacturing arrangements
    • 1271.155 exemptions and alternatives
  • Inspections and enforcement

Registration and Listing

  • 606 establishments list reproductive HCT/Ps
    • 2322 total HCT/P establishments
  • Semen - 72 registered that list semen
  • Oocytes - 13 registered that only list oocytes
  • Embryos - 481 list embryos (IVF clinics)

Annual Registration

  • Required every year in December
    • This year - in November:
    • If you registered by mail/FAX annual forms will be mailed
    • If you registered electronically - you will only be reminded by email. Make sure your reporting official's email address is correct and not blocked
  • Public query on the web www.fda.gov/cber/tiss.htm

Donor Eligibility Determination

  • Required for anonymous/directed donors
  • Procedures/records required
  • Summary of records must accompany the HCT/P
  • Required testing within specific time periods from recovery
  • Required screening
    • Current donor medical history interview
    • Current physical assessment

Donor Eligibility - Semen

  • Anonymous

    • 6 month quarantine (cryopreserved)
    • Negative (re-)test/screen before release
    • Test within 7 days before initial recovery

  • Directed/known

    • No quarantine
    • Recent screen
    • Test within 7 days before recovery
    • If test/screen positive the donor is ineligible
      • still can be used with physician notification and labeling

Donor Eligibility - Oocytes

  • Anonymous

    • Recent negative screening
    • Test negative within 30 days before recovery

  • Directed/Known

    • Recent screening
    • Tested within 30 days before recovery
    • If test/screen positive the donor is ineligible
      • still can be used with physician notification and labeling

Donor Eligibility - Embryos

  • Not required for use by sexually intimate partners
  • Not required if excess embryos intended for sexually intimate partners are subsequently cryopreserved and then donated
  • Required for gamete donors intended to form embryo for use in gestational carrier

Embryo Donation

  • Cryopreserved excess embryos intended for use by a sexually intimate couple or individual can be donated

    • Anonymous or directed
      • Couple or individual
      • Gestational carrier
    • Test/screen recommended at time of donation
    • Special labeling required

  • If a qualified 3rd party donor is used - embryos can still be donated

Relevant GTP's

  • Manufacturing arrangements

    • Ensure that an establishment that performs a step in manufacture for you (under contact, agreement, or other arrangement) is in compliance (testing lab) with applicable requirements
    • Guidance published - September 2006

  • Exemptions and Alternatives

    • From DE or GTP requirements
    • Must be consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases

Other Issues

  • Failure to register
    • 95 repro
    • 368 total
  • Improper testing of donors
    • Use of diagnostic tests rather than donor screening tests
    • NAT testing using pooled samples rather than individual test samples
  • Distribution of gametes from donors residing in countries where there is a CJD/vCJD risk identified

In Progress

  • Final Donor Eligibility Guidance
  • Draft GTP Guidance
  • Guidance on Testing Using Pooled Samples or Diagnostic Tests
  • Finalization of Interim Final Rule of 5/25/05
  • For Published Documents: http://www.fda.gov/cber/tissue/docs.htm

CONTACT INFORMATION

Jackie Neidinger, BS, CTBS
Human Tissues and Reproduction Branch
Division of Human Tissues, OCTGT
CBER/FDA
1401 Rockville Pike (HFM 775)
Rockville, MD 20852-1448

Jackie.Neidinger@fda.hhs.gov
301-827-6038

 
Updated: December 11, 2006