Codex Tsunami: FDA's Friedman
Made No Bones About It.....
How Soon People Forget..... Information provided by John Hammell
IAHF
January 5, 2005
On July 7, 1997 Acting FDA Commissioner
Robert A. Friedman stated the following in a speech before the
Senate Labor Committee:
FDA and the Global Marketplace:
International Harmonization
The regulatory framework administered by the Food and Drug
Administration (FDA) to provide public health and safety
protection to American consumers is a model that many
countries strive to emulate. At the same time, FDA recognizes
that we operate in an increasingly more global, more
interdependent market environment, and that American consumers
can realize significant public health and economic benefits
from efforts by FDA to share information, explore
opportunities to collaborate on assessments and product
reviews, and harmonize standards with its foreign
counterparts. Growing demands on FDA's resources to assure the
safety and efficacy of greater numbers of increasingly more
complex products produced both here and abroad, absolutely
mandate that FDA seek ways in which it can share its
regulatory workload while maintaining public health protection
for American consumers. Science driven harmonization can
curtail duplication and thereby significantly reduce the cost
of new drug development, in terms of the risks to which
patients are exposed, the experimentation with animals, the
regulatory costs to government and the cost to industry.
For many years, FDA has actively engaged in the kinds of
information exchange that lay the foundation for the
development and maintenance of high international standards,
and pave the way for harmonization activities. We have entered
into numerous Memoranda of Understanding (MOU) with other
governments to ensure that their products intended for export
to the United States adhere to our strict standards of health
and safety protection. We also participate in limited and
focused education and training initiatives that instruct
others in how to conduct their activities so that products
shipped to the U.S. will be in accord with U.S. requirements.
We exert leadership in a number of international
standard-setting organizations.
FDA has been a strong supporter of, and participant in, the
Codex Alimentarius Commission (Codex). Codex is an
international standards-setting organization for food safety
composed of national governments from more than 150 countries.
The work of Codex is increasingly important with the
recognition of Codex as the relevant international
standards-setting body for food safety in the Agreement on the
Application of Sanitary and Phytosanitary Measures (SPS)
resulting from the Uruguay Round of multilateral trade
negotiations.
Since its inception, Codex has developed in excess of 200
Commodity Standards, more than 40 codes and guidelines, about
2,500 pesticide/commodity maximum limits, and has reviewed the
safety of over 500 food additives and contaminants. FDA,
through its participation on most Codex Committees, provides
scientific and regulatory expertise and forcefully presents
U.S. views at the committee meetings.
FDA plans to amend its regulations and procedures for
consideration of standards adopted by Codex. This action is
being taken to provide for the systematic review of the Codex
Standards in order to enhance consumer protection, promote
international harmonization and fulfill obligations of the
United States under international agreements.
In recent years, we have put considerable effort into the work
of the International Conference on Harmonization (ICH),
working closely with our regulatory counterparts in Japan and
the European Union, as well as the three areas' organizations
representing the major research and development pharmaceutical
companies (e.g., the Pharmaceutical Research and
Manufacturer's Association (PhRMA)). The goal of ICH is to
harmonize across all three regions the requirements for data
submitted to support safety, efficacy and quality
determinations in new drug applications, and to develop
guidelines for the industry based on the harmonized
requirements. The past six years of effort have produced over
40 new harmonized guidelines, and another 20 are in various
stages of development and review. The ICH effort is one of the
best examples of a forward-thinking Agency that is willing to
work not only with its regulatory counterparts, but with the
regulated industry as well, to develop guidelines harmonized
to the highest standards while also eliminating costly
duplication of effort. Similar efforts are underway in the
areas of medical devices and veterinary drugs.
Additionally, for the past three years we have been involved
in negotiations to give limited recognition to inspections of
drug and device facilities by European Union authorities and
to expand the third party device review to include European
Union notified bodies. A successful agreement has the
potential to save resources for both sides, however, FDA must
be satisfied that such an agreement would not compromise our
responsibility for protecting American consumers.
I began this presentation outlining the Agency's
accomplishments for two reasons: first, to demonstrate through
concrete example that this Agency understands the importance
of change. We have tried to be as responsive as possible to
concerns expressed by Congress, consumers, and the industry
and have undertaken reforms in response to these external
criticisms. But change also has been driven by the Agency's
own commitment to efficiently and effectively accomplish its
mission. Five years ago few believed that we would be
approving drugs in twelve months or less. Not only have we
reached that goal, but we are now working cooperatively with
industry to develop more open, cooperative and productive
inspection procedures, and to restructure the regulation of
tissue-based therapies to match regulation to risk. In each of
these areas, and many others, we listen to the criticisms,
engaged all of the stakeholders in defining the problem and
worked with them on devising solutions that preserved and
enhanced critical public health protections.
