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BIO Submits Comments in Response to the OSTP's RFI on the Coordinated Framework for the Regulation of Biotechnology Products

September 16, 2016

November 13, 2015


Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Submitted Electronically via Federal eRulemaking Portal (

Re: Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology.

Dear Sir or Madam:

The Biotechnology Industry Organization (BIO) is pleased to submit these comments in response to the Notice of a Request for Information, published by the National Science and Technology Council, Science and Technology Policy Office1. BIO is the world's largest biotechnology trade association, representing more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. Our members are involved in the research and development of healthcare, agricultural, food, industrial and environmental biotechnology products, and BIO represents the majority of the biotechnology product developers in North America. Accordingly, BIO is especially interested in the Administration’s efforts to

  • clarify the roles and responsibilities described in the Coordinated Framework for the Regulation of Biotechnology Products2; and
  • develop a long-term strategy for the regulation of biotechnology products.

BIO supports the objectives of this initiative, as articulated in the 2 July 2015 memorandum from the Executive Office of the President (EOP), i.e., to

  • ensure public confidence in the regulatory system, and
  • prevent unnecessary barriers to innovation, while continuing to protect health and the environment.

BIO agrees that the time is right for a review of the Coordinated Framework. The agencies now have 30 years of experience reviewing information and data submitted for field trials and commercial approvals, conducting risk assessments, reviewing independent safety studies published in peer-reviewed journals, and evaluating the performance of products that were commercialized. Their diligence has made it possible for BIO members to develop products that have improved the productivity of plant and animal agriculture while decreasing their environmental impacts, enhanced food safety and quality, increased the use of renewable resources and decreased manufacturing costs and energy use. The availability of biotechnology-derived products has not only afforded consumers opportunities to weigh their benefits, it has also allowed regulators and developers to confirm their safety to human health, animal health and the environment. Finally advances in science and technology have provided insights into molecular biology and genetics that have led to a much greater understanding of the genomes of all organisms. That understanding is an essential lens through which the products of genetic engineering should be viewed.

BIO members greatly appreciate this Administration’s efforts to “encourage regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies or creating trade barriers,” and our members are encouraged to hear that the Administration will apply these same principles to this review of the regulatory framework and systems that regulate the products of biotechnology.

Download Full Comments Below
BIO Comments Coordinated Framework Clarification
Read BIO's Comments Here in their Entirety
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