Manufacturing Today - November/December 2016 - 13

LYNN L. BERGESON | COLUMN BY

Future of Biotech

white house proposes an update to
the coordinated framework

> A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA and USDA
for the oversight of an array of
biotechnology product areas.

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P RO F I TA B I L I T Y

M A N U FA C T U R I N G

AH
S R EXPO 2016

L E A N

S U S TA I N A B I L I T Y

SERVICE

In July 2015, the White House 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 issued a memorandum directing the U.S. Environmental Protection Agency (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. Last updated in 1992 and first rolled out in 1986,
the Coordinated Framework outlines
a comprehensive federal regulatory
policy for products of biotechnology.
The memorandum directs the federal agencies to develop a long-term
strategy to ensure that the regulatory
system for biotechnology products
is prepared for future products, and
commissions an expert analysis of
the future landscape of biotechnology products. On Oct. 6, 2015, OSTP
issued a request for information to
solicit relevant data and information,
including case studies that may assist
in the development of the proposed

update to the Coordinated Framework for the Regulation of Biotechnology. The administration also held
three public engagement sessions.
The White House states that the
proposed update to the Coordinated
Framework "offers the public a complete picture of a robust and flexible
regulatory structure that provides
appropriate oversight for all products
of modern biotechnology." Within
that regulatory structure, the federal agencies "maintain high standards
that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and
efficient regulatory practices." To
help product developers and the public understand what the regulatory
pathway for biotechnology products
might look like, the proposed update
presents information about agency
roles and responsibilities in several
forms, including:
> Graphics that illustrate agency-specific overviews of regulatory roles;
> Case studies that show how a
product developer might navigate
regulatory framework; and

According to the White House, the
National Strategy 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 National Strategy, the federal
agencies demonstrate their sustained
commitment to ensuring the safety
of future biotechnology products,
increasing public confidence in the
regulatory system, and preventing
unnecessary barriers to future innovation and competitiveness.
The National Strategy highlights
many existing and new activities at
EPA, FDA and USDA, including the
following key commitments:
> EPA, FDA and USDA will review
existing communication tools
and, as appropriate, may revise
existing or develop new user-friendly sources of regulatory
information for product developers and the general public;
> EPA, FDA and USDA are emphasizing their commitments to interagency communication and
collaboration to make timely
decisions on regulatory jurisdiction for biotechnology products
and to optimize the review and
use of scientific data for regulatory assessments;

SPACE TECH EXPO

Updating the
Coordinated Framework

National Strategy

C ANADA MANUFACTURING

On Sept. 22, 2016, the White House issued a notice seeking comment on two documents intended to modernize federal regulation
of biotechnology products: a proposed update to the Coordinated
Framework for the Regulation of Biotechnology and a National
Strategy for Modernizing the Regulatory System for Biotechnology
Products. The notice is much anticipated for manufacturers producing or using products of biotechnology. This article discusses
the documents and their importance to U.S. manufacturers.

NOVEMBER/DECEMBER 2016 manufacturing-today.com

13


http://manufacturing-today.com

Table of Contents for the Digital Edition of Manufacturing Today - November/December 2016

Table Of Contents
Manufacturing Today - November/December 2016 - Cover1
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Manufacturing Today - November/December 2016 - Cover3
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