Regulatory Developments

Biotechnology: Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9

February 29, 2016

The second public meeting on the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products" will be held March 9, 2016, from 9:30 a.m. to 1:00 p.m. (CT) in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. According to the U.S. Environmental Protection Agency (EPA), the March 9, 2016, meeting will illustrate the current federal roles and responsibilities regarding biotechnology products. EPA's web page regarding the second public meeting includes links to associated documents. EPA will post the meeting agenda on the web page prior to the meeting.

Background

The July 2, 2015, memorandum was jointly issued by the Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality, and directs EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology, and describes the federal regulatory policy intended to ensure the safety of biotechnology products. The Administration's initiative has three key components. First, the Administration will update the Coordinated Framework, after accepting public comment, to clarify the "roles and responsibilities" of the federal agencies that now regulate the products of biotechnology: EPA, FDA, and USDA. It is hoped that this process will clarify which biotechnology product areas are within the authority and responsibility of each Agency, and will better outline how the Agencies can work together to regulate products that fall within the respective jurisdictional scope of each Agency. Second, the Administration will commission an external, independent analysis of the future landscape of biotechnology products. The Administration has asked that the National Academies of Sciences, Engineering, and Medicine (The Academies) conduct such an analysis. Candidates for inclusion on The Academies' panel were solicited in January 2016. Third, the Administration will formulate a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology. This component is essential and holds considerable promise in developing a game plan for achieving success.

The first public engagement session took place on October 30, 2015, at the FDA's White Oak Campus in Silver Spring, Maryland. Opening remarks were given by John Holdren, Ph.D., Assistant to the President for Science and Technology and Director of OSTP. Roberto Barbero, Ph.D., Assistant Director for Biological Innovation at OSTP, gave an overview on what OSTP is doing and how, as well as the principles that have led up to OSTP's current efforts. Representatives from USDA's Animal and Plant Health Inspection Service, EPA, and FDA also delivered statements on the federal regulation of biotechnology products. Interested parties in attendance included a number of non-governmental organizations that spoke out against the use of biotechnology, academic institutions that were supportive of continued research, and industry participants that were supportive of reasonable risk-based regulation to oversee biotechnology's continued growth. A transcript from the meeting is available online.

More information regarding the Coordinated Framework is available in our October 6, 2015, memorandum OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and in our July 6, 2015, memorandum White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology.

Commentary

The Administration's efforts to modernize the Coordinated Framework are essential, laudable, and timely. It is imperative that stakeholders participate actively and effectively in sharing their experiences under the Coordinated Framework with the Administration. The forthcoming public meeting in Dallas is an excellent opportunity to communicate both successes and less successful experiences with the government's regulation of products of biotechnology. There is only one remaining public meeting opportunity after Dallas. After the third and final meeting, the Administration will assess all the comments provided in response to the public meetings, and then will seek the public's comments on its thoughts on modernizing the Coordinated Framework. Stakeholders are urged to attend or participate virtually in the public meeting, and to help develop a more timely, efficient, and current governance framework for products of biotechnology.


 
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