/>iAfter launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and it also completed work on a National Strategy for Modernizing the Regulatory System for Biotechnology Products. Together, these documents clarify the authority that Federal administrative agencies have to regulate certain products of biotechnology and they establish goals to ensure the proper use of those authorities in the future.
First, the Working Group’s proposed Update to the Coordinated Framework outlines the specific roles that FDA, USDA, and EPA serve to regulate biotechnology-derived products and the ways in which the agencies work together when those roles overlap. The Coordinated Framework, as noted in the Administration’s corresponding blog post, presents this information in three forms:
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“graphics that illustrate agency-specific overviews of regulatory roles;
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case studies that demonstrate how a product developer might navigate the regulatory framework; and
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a comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.”
The Administration is soliciting public comment on its proposed Update. The deadline for submitting comments will be forty days after the Update is published in the Federal Register.
Second, the Working Group’s National Strategy dovetails with the Coordinated Framework, by listing a number of objectives related to the agencies’ use of their regulatory authorities. It groups these objectives under three overarching goals: “increasing transparency, increasing predictability and efficiency, and supporting the science that underpins the regulatory system.”
EPA, FDA, and USDA have agreed to report annually to the White House on their progress in meeting these three goals for at least the next five years. In addition, sometime soon, the Working Group plans to release a study on the future of biotechnology, the one item remaining on the group’s to-do list announced at its inception last year.
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