Biologics

HHS Cancels FDA Fetal Tissue Contract

HHS says it has canceled an FDA contract with Advanced Bioscience Resources to provide human fetal tissue used to develop drug testing protocols. In a brief statement, the department said it was “not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.”

The agency says it is conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations. It also has opened what it terms a “comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.”

HHS says it is continuing to review whether adequate alternatives exist to the use of human fetal tissue in HHS-funded research, and will ensure that efforts to develop such alternatives are funded and accelerated.

BioSpace reports online that the HHS action follows concerns raised by a number of House members about Advanced Biosciences Research’s practice of selling the tissue. Some 85 members reportedly signed a letter to FDA commissioner Scott Gottlieb saying the company could have violated the law by “selling the body parts of children” for a profit. In their letter, the legislators told Congress the company said it acquired the fetal tissue from abortion clinics by paying $60 per aborted fetus and then selling the tissue to researchers for $325 per specimen.

FDA reportedly used the tissue in animal testing, implanting it into mice that lacked immune systems to give them “human-like” immune systems so the mice could be used to evaluate the safety and efficacy of various drugs.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome