Revealed Documents Show the FDA Purchasing Aborted Fetal Parts for Research on ‘Humanized Mice’

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In a set of 165 documents obtained and released by Judicial Watch [1] [2], there is frequent talk about the purchasing of fetal tissue by the FDA for a specific need:

“The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is conducting a research program to evaluate the usefulness of humanized mice (HM) for regulatory purposes. The HM are created by surgical implantation of human tissue into mice that have multiple genetic mutations that block the development of the mouse immune system at a very early stage. The absence of the mouse immune system allows the human tissues to grow and develop into functional human tissues. As part of this process DARS needs to repeatedly acquire the proper type of tissues. In order for the humanization to proceed correctly we need to obtain fetal tissue with a specific set of specialized characteristics.”

Emails With FDA Obtained via FOIA

The FDA had a set of requirements for this tissue:

  • “Age range 16-24 weeks
  • Liver and thymus tissue from the same donor unless liver only is requested.
  • Tissue must be fresh and never frozen.
  • No tissues where the mother is known to be positive for HIV or for Hepatitis A, B, or C viruses.
  • No known chromosomal abnormalities.
  • Testing for HIV, Hepatitis B & C will be completed on maternal blood for all
  • tissues procured and results provided when available.”

The FDA ended the contract in 2018, saying: 

“[T]he Government is not sufficiently assured that the human tissue provided to the Government to humanize the immune systems of mice will comply with the prohibitions set forth under 42 U.S.C. § 289g-2. [T]he Government has concerns with the sufficiency of the sole-source justification.” Referenced Sources:
[1]Original Documents
[2] Judicial Watch Report