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United States Pharmacopeia
Dr. Patrick Gallagher

ATTACHMENT 2: LETTER FROM ROGER L. WILLIAMS, M. D. TO
DR. PATRICK GALLAGHER, MAY 19, 2010

May 19, 2010

Dr. Patrick Gallagher

Director

National Institute of Standards and Technology
100 Bureau Drive, Stop 1000

Gaithersburg, MD 20899-1000

Dear Dr. Gallagher:

Speaking on behalf of the United States Pharmacopeial Convention
(USP), | thank you for attending the USP Convention in April. It was nice
to meet you at our networking break. Bill Koch and Mat Heyman have
been keeping me updated on recent discussions with Dr. Willie May and
others at the National Institute of Standards and Technology (NIST) which
hopefully will lead to mutually beneficial interactions on specific areas
where our organizations have complementary roles. In fact, | understand
that a team of NIST and USP staff are meeting this week.

| would also like to congratulate you on the recent creation of the
Subcommittee on Standards under the National Science and Technology
Council's Committee on Technology. We support this important initiative
to further integrate privately-adopted standards into the federal
government. We believe this will play a beneficial role in furthering public
health, science, and commerce.

As you know based on your participation at our Convention meeting last
month, USP is a volunteer driven, not-for-profit, science-based standards-
setting organization founded in 1820 by eleven physicians. USP’s mission
is to improve the health of people around the world through public
standards and related programs that help ensure the quality, safety, and
benefit of medicines and foods. USP public standards are set by more
than 700 expert volunteers from around the world, who give freely of their
time and talent to produce the United States Pharmacopeia—National
Formulary (USP-NF) — official compendia for drugs recognized in federal
law. USP works with the Food and Drug Administration (FDA), which
enforces these standards. We also provide the reference standards,
carefully measured chemical and physical samples, which are key tools
used to help ensure adherence to written standards and quality assurance
requirements.

USP’s primary oversight body is the USP Convention itself, which meets
at five-year intervals. The Convention has over 500 member groups,

5


United States Pharmacopeia | 4
Dr. Patrick Gallagher

I. USP-FDA Quarterly Meetings

Since March 2006 USP and FDA leadership have met quarterly to discuss
compendial and other topics of mutual interest and to promote
collaboration between the organizations. The FDA delegation is led by
Helen Winkle, Director, Office of Pharmaceutical Science, Center for Drug
Evaluation and Research. Ms. Winkle represents the Standards Working
Group, which is an agency-wide group that addresses how FDA works
with standards-setting bodies.

Several working groups have emanated from the Quarterly meeting,
including the Melamine Working Group, and two new groups, the
Compounding Working Group and the Monograph Modernization Working
Group. These working groups come together to assure that there is
agency and USP alignment in the development and revision of key
compendial standards. A model for this activity, although it was not
considered to be a Working Group per se, was the initial work that USP
did, at FDA’s request, on the modernization of the heparin monographs.

lll. | Office of the Commissioner and Other Interactions

In addition, USP has had various meetings with the Commissioner and her
deputies, as circumstances warrant and permit.

USP has had multiple meetings with the Center for Food Safety and
Applied Nutrition (CFSAN) and FDA's Office of International Programs.
USP and FDA have significantly improved awareness and mutual efforts
across the globe as a result of new relationships and communications we
established with FDA's Office of International Programs staff in
headquarters as well as in China, India, Europe, and Latin America and
the Caribbean.


United States Pharmacopeia | 6
Dr. Patrick Gallagher

including governmental bodies, and individual members. This makes USP
a unique group committed to assuring the quality and benefit of drugs and
food.

While USP sets standards for drugs and pharmaceutical ingredients,
technically, these standards largely fall outside of the category of voluntary
consensus standards. Although the process used by USP to develop
them is similar in many ways to that of voluntary consensus standard
setting organizations, the standards are not considered voluntary because
compliance is mandated under the Federal Food, Drug and Cosmetic Act.
For this reason the Office of Management and Budget's Circular No. A-
119 explicitly mentions USP-NF as an example of a non-voluntary
standard—but this is not necessarily the case for all USP standards. We
have also been exploring ways that parts of our standards-setting process
might be adopted to a voluntary consensus-standards-setting model.

In addition to its standards for drugs, USP creates standards for dietary
supplements and food ingredients. Dietary supplement standards are
published as part of the USP-NF, which also contain USP's drug
standards. USP's standards for food ingredients are published in the
Food Chemicals Codex, which USP acquired from the National Research
Council and Institute of Medicine and has now updated to a Seventh
Edition. For the most part, conformance to USP's dietary supplement and
FCC standards is not required by law, and thus they can be considered
voluntary. These standards, if complied with, help assure the safety and
quality of dietary supplements, dietary supplement ingredients and food
ingredients.

If you would like more information please contact me or USP's Director of
Government Affairs, Ben Firschein, baf@usp.org, (301) 816-8235.

Sincerely,

Muth

Roger L. Williams, M.D.
Chief Executive Officer



US, Phormacopeia
The Standard of Quality

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wernusp.org

January 14, 2011

Dr. Patrick Gallagher, Director

National Institute of Standards and Technology
100 Bureau Drive, Stop 1000

Gaithersburg, MD 20899-1000

Re: Request for Information, National Institute of Standards and Technology,
Department of Commerce, Docket Number 0909100442-0563-02, submitted to
SOS _RFI@nist.gov

Dear Dr. Gallagher:

The United States Pharmacopeial Convention (USP) thanks you for the
opportunity to comment on Federal agencies’ participation in standards and
conformity assessment activities and programs. Specifically, you ask what
methods of engagement are used by Federal agencies to participate in private-
sector-led standards development, how transparent is each method, how
effective methods are, and how methods can be improved.

As a private not-for-profit volunteer-led standards-setting organization, USP
appreciates the importance of initiatives to increase the uptake of private
standards into the federal government. We recognize the significant mission of
the National Technology Transfer and Advancement Act and the work of the
Sub-Committee on Standards under the National Science and Technology
Council's Committee of Technology.

USP wishes to comment on the many positive standards-setting interactions we
have had with the Food and Drug Administration (FDA). Those interactions are
highlighted below and in Attachment 1. Opportunities exist for enhanced
cooperation, as we are discussing with the FDA. The adoption of national public
standards is of great importance as we work to enhance the safety net and
protect the public; we therefore appreciate the FDA and its unique public health
mission.

We previously described to you our standards-setting programs (Attachment 2).
While USP standards for drugs and pharmaceutical ingredients are recognized in
law and therefore largely fall outside of the category of voluntary consensus
standards, the open, transparent, and highly participatory process used to
develop them is similar in many ways to that of voluntary consensus standard
setting organizations. It involves close cooperation with the FDA and
stakeholders, since our drug quality standards are enforceable by that agency.

Conversely, conformance to USP's dietary supplement and food ingredient
standards is not generally required by law—and they are thus voluntary. They
adhere to the same open processes and stakeholder input as with our drug
quality standards. Nevertheless, FDA references USP dietary supplement
standards in a number of areas related to nutrition and also cites USP food
ingredient standards in over 200 regulations. We have encouraged FDA to
update references to the most recent version of these standards in USP’s Food
Chemicals Codex (FCC), recently published in a Seventh Edition.


United States Pharmacopeia
Dr. Patrick Gallagher

We are working to ensure that as soon as standards need to be added or updated, we can do
so and they are taken up by FDA—a more or less automatic process for drugs, and an
emerging one for food ingredients as we experiment with food additive petitions and other
mechanisms.

USP is largely dependent on industry to provide it with the information and candidate materials
needed to create up-to-date standards. We therefore appreciate FDA's continued interest in
collaborating with USP to encourage industry to work closely with us to update standards—
heparin and glycerin are recent success stories.

We noted the Commissioner's comments at the USP Convention in April 2010 highlighting the
need for continued cooperation between FDA and USP in support of up-to-date public
standards. She said: “Together, we have tackled a variety of important projects. We have
collaborated on scientific standards for drugs, medical devices, and other products; created a
Reference Standards program as well as standards for insulin and antibiotics; and established
reporting programs for drugs and medical devices. But there is still a great deal of work to be
done.” The Commissioner also remarked, “In the coming years, we would like to share
information about ways to help manufacturers make and market safe dietary supplements. We
would also work together to develop methods to detect contaminants, including
pharmaceuticals, in dietary supplements and foods.”

Among the resolutions adopted by Convention delegates at that meeting was Resolution 3,
which calls on USP to strengthen its relationship with the FDA
(http:/Awww.usp.org/aboutUSP/resolutions. html).

We believe FDA can play an even more pivotal role in encouraging industry to work with USP to
develop the new methods needed to update monographs. In addition, we are exploring with
FDA ways it can provide input earlier in the process and furnish more complete information that
will allow modernization proposals to be finalized more quickly, and we have developed working
groups and other activities. These efforts by USP and its volunteers do not cost taxpayer
dollars and they save the government needed resources while improving the safety net.
They are a model for additional public-private partnerships in an era of scarce resources.

Thank you for the opportunity to comment.

Sincerely,

(Mute —

Roger L. Williams, M.D.
Chief Executive Officer
Attachment

2


United States Pharmacopeia | 3
Dr. Patrick Gallagher

ATTACHMENT 1: SUMMARY OF FDA-USP INTERACTIONS

I. Compendial Interactions with the Food and Drug
Administration

As the regulatory authority for drugs and many foods in the United States,
the Food and Drug Administration (FDA) is a major stakeholder in USP's
activities. Traditionally, USP and FDA have worked together to develop
standards and to ensure their appropriate implementation, primarily
through the FDA Compendial Affairs Office. Paul Seo, Ph.D., serves as
FDA's Director of Compendial Operations. Dr. Seo coordinates FDA's
representation on USP Expert Committees and Expert Panels as well as
FDA's comments on USP's standards proposals. He also coordinates
responses to day-to-day questions posed by USP’s scientific liaisons
regarding the FDA approval status. There currently are 66 FDA liaisons
who are assigned to USP’s 20 Expert Committees. USP anticipates that
the number of FDA Liaisons will grow as Expert Panels are formed
throughout the cycle.

In addition, FDA representatives participate in USP Workshops, Annual
Meetings, Stakeholder Forums, Project Teams, and other special topic
meetings.

At the beginning of the 2005-2010 cycle, FDA employees served both as
members of and FDA Liaisons to USP’s Expert Committees and Advisory
Panels. In 2007, as a result of FDA's revision to its Staff Manual Guide
(SMG), FDA employees serving as members of USP Expert

Committees and Advisory Panels transitioned to FDA Liaisons and
assumed an advisory, non-voting role on USP’s Expert Committees. This
transition arose from USP’s long-standing policy that members of the
Council of Experts participate in based on their expertise and not the
organization they represent, which was no longer possible for FDA under
the SMG (which required FDA employees to serve solely as FDA
representatives).

A new CRADA between USP and FDA's Office of Regulatory Affairs
(which is pending approval at FDA) has as one of its objectives the
development of new methods for monograph modernization. We
recognize that FDA's laboratory resources, like USP’s, are limited, but
believe that by coordinating our efforts, more can be accomplished in a
shorter amount of time.