White House Calls for Modernization of Biotechnology Regulations

August 04, 2015
Post by No items found.

Biotechnological innovation is potentially subject to a variety of governmental regulations. For example, therapeutics for disease treatment or prevention in humans are subject to review and approval by the Food and Drug Administration (FDA). Innovations relating to crops or livestock may be subject to the Department of Agriculture (USDA). However, the regulations promulgated by these governmental agencies are all based on a Coordinated Framework established by the Office of Science and Technology Policy, which was last updated in 1992. Recognizing that the Coordinated Framework, and the regulations based thereon, are in need of a significant update, the White House issued a memorandum on July 2, 2015, initiating "a process to modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system.‚¬ 

Among the stated goals of the initiative are clarifying the roles and responsibilities of the various agencies that regulate the products of biotechnology, including which biotechnology product areas are within the authority and responsibility of each agency, and how the various agencies interact within biotechnology areas.

Given the enormous amount of innovation that has occurred since the last update to the Common Framework in 1992, this initiative has the potential to bring the numerous governmental regulations in the biotechnology sector into closer alignment with scientific reality.  In addition, the initiative specifically calls for input from the public, providing an opportunity for those involved in biotechnology innovation to help shape the future of regulations in this area.

The full memorandum is available here.

Post Categories

Comments (0)
Post a Comment

Captcha Image
Return to the Filewrapper Blog

Search Posts


The attorneys of McKee, Voorhees & Sease, P.L.C. designed this blog as an informational and educational resource about intellectual property law for our clients, other attorneys, and the public as a whole. Our goal is to provide cutting-edge information about recent developments in intellectual property law, including relevant case law updates, proposed legislation, and intellectual property law in the news.


McKee, Voorhees & Sease, P.L.C. provides this blog for general informational purposes only. By using this blog, you agree that the information on this blog does not constitute legal or other professional advice and no attorney-client or other relationship is created between you and McKee, Voorhees & Sease, P.L.C. Do not consider this blog to be a substitute for obtaining legal advice from a qualified, licensed attorney. While we try to revise this blog on a regular basis, it may not reflect the most current legal developments. We consciously refrain from expressing opinions on this blog and instead, offer it as a form of information and education, however if there appears an expression of opinion, realize that those views are indicative of the individual and not of the firm as a whole.

Sign Up For Our Newsletter

Enter your name and email address to receive the latest news and updates from us and our attorneys.

Subscribe to: MVS Newsletter

Subscribe to: Filewrapper® Blog Updates

  I have read and agree to the terms and conditions of McKee, Vorhees & Sease, P.L.C.