Friday, September 16, 2016

Governing Biotechnology

As noted last year by Lexvivo ("Recoordinated Framework", July 2, 2015), the United States federal government has been considering how to update its policy on biotechnology regulation.  On September 16, 2016, the White House released a draft revision of the "Coordinated Framework for the Regulation of Biotechnology" (commonly known as the "Coordinated Framework").  (Thank you to the brilliant Brian Mannix for alerting me about the draft's release.)  The original policy, in force since June 26, 1986, can be found here.  The draft new policy, entitled "Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology", can be found here.  The White House described its reformulated biotechnology regulatory policy as follows:
[It] sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. In the [draft new policy], the Federal agencies demonstrate their sustained commitment to ensure the safety of future products of biotechnology, increase public confidence in the regulatory system, and prevent unnecessary barriers to future innovation and competitiveness.
Biotechnology has evolved rapidly and radically over the past three decades, so a comprehensive review of the policies that oversees its regulation would seem overdue, especially in light of signal innovations like de novo gene synthesis and in toto genome editing.  Let's hope that this proposed recoordination of policy on that most complex of technologies avoids tripping over its own feet.