BIO Supports Efforts to Modernize Biotech Reg Process

Regulation System Must Encourage – not Hinder – Innovation

Washington, D.C. (July 2, 2015) – The Biotechnology Industry Organization (BIO) welcomes the release of a White House memo regarding the regulation of biotechnology-derived products.

“BIO commends the White House for recognizing that coordination between the agencies that oversee the approval of biotech products – the U.S. Departments of Agriculture, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency – must be a priority to encourage innovation by improving transparency, timeliness and predictability of the regulatory system,” said Matt O’Mara, acting vice president of BIO’s Food & Agriculture Section. 

The three agencies each have regulatory authorities under the U.S. Coordinated Framework for the Regulation of Biotechnology.  Established as a formal policy in 1986, the Coordinated Framework ensures the health and environmental safety of biotechnology-derived products and, as such, has provided the scientific bedrock on which biotechnology innovation has flourished in the United States over the past three decades. 

The Coordinated Framework has come under criticism in recent years for impeding the timely approval of much-needed and long-reviewed biotech products.  USDA, however, has since implemented new processes to address the issue.  And similar efforts across all three agencies would prove increasingly beneficial, BIO says.

“BIO supports a regulatory system that is timely, predictable, based upon the best available science, and incorporates 20+ years of experience with the technology,” says O’Mara. “We look forward to reviewing the proposal in more detail and working with the administration on this moving forward.”