FDA Paid for Human Fetal Parts for Use In ‘Humanized Mice’ Creation

(Washington, DC) – Judicial Watch announced today it received 165 pages of records from the Food and Drug Administration (FDA) showing the FDA between 2012 and 2018 entered into eight contracts worth $96,370 with Advanced Bioscience Resources (ABR) to acquire “fresh and never frozen” tissue from 1st and 2nd trimester aborted fetuses for use in creating “humanized mice” for ongoing research.

ABR is a non-profit firm which has been the subject of criminal referrals from House and Senate committees investigating whether Planned Parenthood or any other entity was illegally profiting from the handling of fetal tissue from aborted babies.

Federal law regulates the purchase and acceptance of human fetal tissue for research purposes. It is unlawful to knowingly transfer fetal tissue for profit.

Judicial Watch filed the lawsuit in the United States District Court for the District of Columbia (Judicial Watch v. U.S. Department Health and Human Services (No. 1:19-cv-00876)) after HHS failed to respond adequately to a September 28, 2018, FOIA request seeking:

1. All contracts and related documentation between FDA and Advanced Biosciences Resources (ABR) for the provision of human fetal tissue to be used in humanized mice research.
2. All records reflecting the disbursement of funds to ABR for the provision of human fetal tissue to be used in humanized mice research.
3. All guidelines and procedural documents provided to ABR by FDA relating to the acquisition and extraction of human fetal tissue for its provision to the FDA for humanized mice research.
4. All communications between FDA officials and employees and representatives of ABR related to the provision by ABR to the FDA of human fetal tissue for the purpose of humanized mice research.

The new production of records shows a June 28, 2017, email exchange with the subject line “FDA RFQ” (Request for Quotation) between a redacted FDA contract specialist and an ABR official named Ms. Larton, in which the FDA official tells the ABR official, “I am tasked with the purchase of tissues suitable for HM [humanized mice] research. I would like to request a quote. Please review the Statement of Work and quote your pricing as outlined.” She then includes a table for 16 “Human Fetal Tissue – Liver”, 16 “Human Fetal Tissue – Thymus”, 16 HIV, HepA, HepB, HepC tests, and shipping and delivery. The Statement of Work notes:

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.

Among the specific characteristics are that the tissue be “Age range 16-24 weeks” and “Tissue must be fresh and never frozen.” An ABR official responds, saying “Your quote is attached.

In a June 12, 2017, email thread related to a “contract closeout” of a $24,500 contract between the FDA and Advanced Bioscience Resources (ABR) in a project titled “Human Tissue”. An FDA official emails an ABR official asking to “confirm all the items/services requested under this order were delivered and all payments processed, so that I may close out this contract…. Our records indicate funds in the amount of $15,090.00 to be de-obligated as a result of this closeout.” A screen shot of a database (called UFMS) print-out indicates a “Matched Amount” of $9,410. The difference between the “matched amount” and the contract value is $15,090. An ABR official responds on June 26, 2017, saying, “I confirm there are no outstanding invoices or [redacted] P.O. #HHSF223201510746P, and it is my understanding that there are no pending requests for tissue procurements on this P.O. at this time.”

In an email thread beginning July 14, 2017, an FDA contracting specialist advises ABR that “In order to properly document pricing, I require some documentation of your prices as offered to the public.” They ask for either redacted invoices or “a place on your website that lists prices”. An ABR representative responds:

We do not have a website, and we don’t allow ‘the public’ to request tissue. It is only sent to verified researchers who have applied and have been approved to receive tissue.

As we are not selling items, we do not have prices. We assess fees for our services. The only document provided then to qualified recipients would be our Fees For Services Schedule. I ‘ve attached another copy of our current Fee Schedule for your reference. We’re a small non-profit company, and the fees are the same for everyone.

I hope this fulfills your requirement. We’ve done business with the F.D.A. for many years and we’ve not experienced such rigorous procedures for the production of purchase orders. Will this process be necessary for each P.O. created now?

The “Fees for Services Schedule” provided by ABR lists “Fetal Cadaverous Specimen Procurement” that includes pricing for “2nd trimester specimen (13 – 24 weeks)” and “1st trimester specimen (8 – 12 weeks),” with the pricing amounts redacted. Under a section titled “Special Processing/Preservation” are fees for “Specimen ‘cleaning’”, “Snap freezing (LN2)”, “Passive freezing (dry ice)” and “Foreign shipments.”

A July 25, 2018, FDA “Order for Supplies or Services” to ABR called for the purchase of “humanized mice” for the period July 26, 2018, to July 25, 2019, for a contract amount of $15,900. The contract called for the provision of 15 sets of second trimester livers and thymuses, along with associated “HIV/HA/HB blood testing,” and shipping.

In a September 17, 2018, email from the FDA to ABR notifying ABR of the “Closeout” of for “Tissue procurement for humanized mice”, the FDA notes the contract value was $9,900, and that remaining funds for the purchase order existed of $2,430. The FDA asks ABR to “confirm if all the items/services requested under this order were delivered so that I may close out this contract.” The responding ABR official notes that although the FDA said that no invoices were submitted under the purchase order, and the ABR official adds that the FDA acknowledged that “there is a $7,470 difference between the noted Contract Value of $9,900 and REMAINING FUNDS of $2,430.” ABR further advises they would submit nine invoices under the contract, all of which were paid.

On September 24, 2018, the FDA terminated a contract with ABR to provide fetal tissue, 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.” The letter adds that “[T]he Government has concerns with the sufficiency of the sole-source justification.”

The law 42 USC 289g-2 involves “Prohibitions regarding human fetal tissue.”

HHS said in a statement on September 24, 2018, it was “conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations.”

“These documents are a horror show,” said Judicial Watch President Tom Fitton. “These records show that the FDA was trafficking in human fetal parts. Incredibly, there continues to be a push to reopen these monstrous experiments!”

In February, Judicial Watch uncovered 676 pages of records from NIH showing that the agency paid thousands of dollars to California-based ABR to purchase organs from aborted human fetuses to create “humanized mice” for HIV research.

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