Monetizing a Systematic Process for Biotech Products


    On July 2, 2015, the US Office of Science and Technology Policy of the Office of the President issued a memorandum to initiate a process to coordinate, update and bring up to date the federal regulatory system governing biotechnology products. The Process structured in the OSTP memo will affect the way the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the U.S.

    Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA) and various agencies control biotechnology products. The OSTP first issued a Coordinated Structure (CF) for Regulation of Biotechnology in 1986 and updated the CF in 1992. The 1986 CF laid the foundation for a systematic effort among agencies to balance regulation with innovation, while the updated 1992 CF took a risk-based approach to regulation, focusing on the environmental and ecological aspects of introducing biotechnology products into the environment

    Since the 1992 update, major advances in biotechnology, involving the progression of recombinant DNA technology and development of synthetic biology structures, have necessitated additional regulations.

    These types of regulations, yet, have led to uncertainty in agency jurisdiction and lack of issues with the process highlighted in the memorandum. As it stands out, the memorandum focuses on the biotech products, such as products built and produced through genetic engineering or in vitro manipulation, yet not human drugs or medical service.


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