Tomorrow is the deadline to submit comments on the Update to the Coordinated Framework for the Regulation of Biotechnology. The Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) regarding regulation of biotechnology products.
In September of this year, the Obama administration issued their Update to the Coordinated Framework document to modernize the regulatory system for biotechnology products. The administration asked those agencies to “clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process; develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and commission an expert analysis of the future landscape of biotechnology products.”
Essentially, the document represents the Obama administration’s yearlong review of the biotech approval process, and, as summarized by Politico, “calls for the agencies to work with industry to streamline approvals, help small businesses that want to develop biotech products, increase the transparency of the approval process and periodically check for new technologies that could fall outside of the regulatory system.”
Per the White House blog, the administration seeks feedback from significant stakeholders, including companies, universities and research institutes, trade associations, scientific societies, and individual citizens. Interested parties may leave comments here.