FARM ANIMAL THAT PRODUCES HUMAN DRUGS

This case study was presented by the Office of Science and Technology Policy (U.S.A.) and it includes the following parameters:

Description of proposed organism/product and its use

Relevant regulatory agencies, regulatory authority and legal measures

Hazard identification and risk assessment

Information and data

Mitigation and management considerations: approvals and conditions on research, development, production, distribution, marketing, use and disposal

Monitoring and consideration of new information

Enforcement and compliance

Public involvement and transparency

One of the missions of OSTP is to ''Build strong partnerships among Federal, State, and local governments, other countries, and the scientific community''. It is a distinct possibility that the policies enforced today by the U.S. will be imposed on a global level tomorrow. As known public science comities in many countries have a decorative role, their decisions are made in the classic style of formal plagiarism. This case study will probably be the face of things to come for the rest of the world.

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CASE STUDY No. IV
FARM ANIMAL (GOAT) THAT PRODUCES HUMAN DRUGS

Overview

This case study examines in a general way the proposed use of genetically engineered animals to produce protein biologics for use in human therapy, referred to herein as “human biologics,” “human proteins,” or “transgenic proteins,” including the disposition of those animals. The case study uses the example of a goat engineered to express a human protein in its milk. The protein is then extracted and purified for therapeutic use in humans. While there are products under review, because no such product has completed the Food and Drug Administration (FDA) regulatory process, this case study is relatively general.

PDF of the case study

Link to the OSTP