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Report from Washington D.C. Metro Area No.2 June 2010

Nobuo UEMURA        06/25/2010



  In mid-February I moved to the United States Pharmacopeia (USP) secretariat office as a visiting scientist of USP General Chapter team from Japan and a liaison official of MHLW/PMDA ("Ministry of Health, Labour and Welfare" and "Pharmaceuticals and Medical Devices Agency").

  This is the second report on the USP and FDA issues. However this report is my personal views and opinions, and it does not necessarily represent the formal position of MHLW, PMDA, FDA and USP.


1. 2010 USP Convention Meeting

  The USP Convention member meeting, organized by representatives from various organizations, guide and facilitate USP's work through discussions, voting on resolutions and Bylaw, and electing the member of trustees and the Council of Experts.

USP Convention is prescribed in the Constitution and its Bylaw, and it has about 500 member organizations including US Colleges and Schools of Medicine, US Colleges and Schools of Pharmacy, State Medical Societies, State Pharmacy Associations, National and State Professional and Scientific Organizations, Governmental Bodies, Health Science and Other Foreign Organizations and Pharmacopeias, Consumer Organizations and Individuals Representing Public Interests, Domestic, Foreign and International Manufactures, Trade and Affiliated Associations.

  From 2010 Convention Japan's Ministry of Health Labour and Welfare/Pharmaceuticals and Medical Devices Agency becomes a member as foreign pharmacopeia. The government bodies include FDA each Centers, National Institute of standards and Technology (NIST), National Institutes of Health (NIH) and others. Also representatives of Canada, Australia, Russia, Brazil and China are invited.

  During the USP Convention Meeting at the April 21-24, 2010, while USP's activities in 2005-2010 revision cycle were reported, delegates from USP member organizations adopted the resolutions toward the new 2010-2015 cycle strategic plan, approved new Bylaws, and elected Council of Experts, Officers and Trustees. (2010-2015 Resolution is in the box bellow.)

  This report explains the USP's recent and future activities based on the information at the Convention.

2. Report of the Council of Experts (activities in the 2005-2010 revision cycle)

  USP's activities under the Council of Experts, which are main activities based on the scientific expertise, are classified by 9 major categories in the report, as follows;
    1) Overview of the Council of Experts
    2) United States Pharmacopeia
    3) National Formulary
    4) Dietary supplement Compendium
    5) Food Chemical Codex
    6) Pharmacists' Pharmacopeia
    7) Reference Standards
    8) International Health
    9) Stakeholder Forum

Also the reports of U.S. Pharmacopeia and National Formulary are divided by 5 groups, as follows;
    1) Nomenclature Expert Committee
    2) Small Molecules Collaborative Group and Expert Committee.
    3) Biologics and Biotechnology Collaborative Group and Expert Committee.
    4) General Chapters Collaborative Group and Expert Committee.
    5) Excipients Collaborative Group and Expert Committee.

Key initiative and Expert Committee Activities in 2005-2010

1) Nomenclature Expert Committee

The Nomenclature Expert Committee changed the Monograph Naming Policy for Salt Drug Substances to express the strength of the product or preparation in terms of the active moiety.

The nomenclature Expert Committee also worked to prospectively name hundreds of drug products for which USP does not yet have monographs.

2) Small Molecules Collaborative Group and Expert Committee.

Collaborative Group of Small Molecules (well-characterized drug substances that do not require a potency test) managed 10 Expert Committees; 1)Antibiotics, 2)Antivirals and Antimicrobials, 3)Cardiovascular, 4)Cough, Cold and Analgesics, 5)Gastrointestinal, Renal and Endocrine, 6)Ophthalmics, Oncology and Dermatology, 7)Psychiatrics and Psychoactives, 8)Pulmonary and Steroids, 9)Radiopharmaceuticals and Magnetic Imaging Agents, 10)Veterinary Medicine.

This group developed more than 250 new monographs and revised more than 540 ones, while modernizing monographs by replacing tests and methodologies, ex replacement of antibiotics microbial assays with HPLC procedures.

This group also developed the Pending Monographs of approved drugs for prompting new monograph submissions, Non-US Monographs for drugs used in the treatment of HIV/AIDS, malaria, and tuberculosis. In addition, this group forwarded new monographs to be included in the Perspective Harmonization pilot study with the European Pharmacopoeia.

3) Biologics and Biotechnology Collaborative Group and Expert Committee.

Collaborative Group of Biologics and Biotechnology (less well-characterized moieties requiring a potency test) managed 4 Expert Committees, such as 1)Blood and Blood Products, 2)Cell, Gene and Tissue Therapies, 3) Proteins and Polysaccharides, 4)Vaccines and Virology, and 25 ad hoc Advisory Panels.

This group developed 16 new and 18 revised monographs, and 14 new and 5 revised General Chapters.

This group started initiatives on Horizontal Standards, for example, general chapter for materials in the manufacturing of monoclonal antibodies and for Biological Potency Tests.

This group also accelerated modernization and revision of the monographs for un-fractionated heparin after the formation of a heparin advisory Panel in 2006, and employed relating USP Workshops and surveys.

4) General Chapters Collaborative Group and Expert Committee.

Collaborative Group of General Chapters managed 10 Expert Committees; 1)General Chapters, 2)Biopharmaceutics, 3)General Toxicology and Medical Device Biocompatibility, 4)Microbiology and Sterility Assurance, 5)Packaging and Storage, 6)Parenteral Products, 7)Pharmaceutical Dosage Forms, 8)Aerosols, 9)Pharmaceutical Waters, 10)Statistics.

This group developed 27 new and 58 revised General Chapters.

This group aligned the General Chapter for "Residual solvents" with corresponding FDA guidance based on the ICH Q3C(R4), proposed new General Chapters for "Elemental Impurities Limits and Procedures" and "Heavy Metals", proposed revision to "Pharmaceutical Dosage Forms", and updated "Good storage and Shipping Practices" being consistent with ICH Q10-Pharmaceutical Quality System.

5) Excipients Collaborative Group and EXPERT COMMITTEE.

Collaborative Group of Excipients managed 3 Expert Committees for Monographs and General Chapters.

This group developed 28 new and 122 revised monographs, and 6 new and 4 revised General Chapters.

This group revised and strengthened the monograph for Glycerin at the request of FDA, including a 0.10% limit of diethylene glycol (DEG) and ethylene glycol (EG).

This revision provides source information for reference standards of DEG and EG.


  Adopted by the USP Convention membership on April 24, 2010.

      Grandfather Constitutionally-Named Organizations
USP resolves that all organizations that were named in the USP Constitution prior to the adoption of the Amended and Restated Bylaws shall automatically become Voting Organizational Members of the Convention under the new Bylaws. These organizations shall continue to be members until they resign or are removed for cause in accordance with the Amended and Restated Bylaws.

      Strengthen Focus on Core Compendial Activities
USP resolves to strengthen its focus on core compendial activities, working collaboratively with academia, industry, regulators and other stakeholders, and utilizing a robust quality management system within USP and its Council of Experts, to ensure relevant, timely and accurate public standards.

      Strengthen USP's Relationship with the U.S. Food and Drug Administration
USP resolves to strengthen its relationship with the Food and Drug Administration (FDA), and work with FDA and other public and private stakeholders to explore mechanisms to enable USP to provide and maintain up-to-date national standards for legally marketed drugs and excipients in the United States.

      Support and Advance Global Public Health Initiatives
Working in consultation and collaboration with national, regional and global stakeholders, USP resolves to assess the feasibility and advisability of advancing global public health initiatives. Where advisable and feasible, USP should seek to expand its resources for these initiatives, building on identified needs and existing opportunities, in order to support its international activities while preserving and fulfilling its role under US law.

      Strengthen and Expand Harmonization Efforts
USP resolves to strengthen and expand its efforts to work with pharmacopeias, industry, academia, regulators, international organizations and other stakeholders around the world to develop harmonized global standards.

      Continue and Expand Commitment to Quality Standards for Food Ingredients
Working in consultation and collaboration with academia, industry, regulators, and other stakeholders, USP resolves to continue and expand its commitment to quality standards for food ingredients, working to strengthen the role of Food Chemicals Codex (FCC) as a global compendium for food ingredients, increasing the number of documentary standards and reference materials based on identified needs, and exploring the feasibility and advisability of expanding the scope of FCC.

      Promote Availability, Use and Recognition of Quality Standards for Dietary Supplements
Working in consultation and collaboration with academia, industry, regulators, and other stakeholders, USP resolves to continue its commitment to provide quality standards for dietary supplements, including strengthening the role of USP standards for dietary supplements products and ingredients and promoting the use and awareness of such standards.

      Develop, Maintain and Promote Adoption of Quality Standards for Compounded Medicines
USP resolves to continue its commitment to standards for compounding, working with the compounding community, regulatory authorities and other stakeholders to develop and maintain optimal process and preparation standards, and promote adoption of such standards by compounding professionals and regulatory authorities.

      Explore Development of Quality Standards of Value to Practitioners and the Public
USP resolves to explore the feasibility and advisability of assisting practitioner groups and other stakeholders to develop quality standards of value to practitioners and the public.

3. FDA Advisory Committee (No.2)

Following the previous report, this article explains the FDA advisory committee.

FDA's 49 Advisory Committee and Panel provide the outer experts' opinions onto the issues relating to 1) approval of new drugs/medical devices, 2)safety of the existing products and safety measures by FDA, 3)other FDA's activities.

The advisory committee intended to discuss approval of new drug/medical device application does not simply vote on the approvability of premarket approval application (NDA/PMA) at the final stage of reviewing, but vote on the safety and effectiveness of the product and its risk versus benefit, during the scientific and in-depth discussion on data and information. This process policy was announced by CDRH on April 26, but CDER has already been taking these procedures on questioning to and voting by the committee.

For example, FDA prepared these 3 questions on voting;

1) Considering the totality of the data, has Product XXX demonstrated substantial evidence of efficacy for the indication of ***?

2) Is the safety profile for Product XXX for the indication of *** to support approval?

3) Do the efficacy and safety data provide substantial evidence to support the approval of Product XXX for the indication of ***?

FDA can provide some additional questions to the Committee to discuss the further points to consider in advance to the voting questions.

These committee procedures will allow FDA to make effective and transparent management of the committee meeting under the increased reviewing workload for new drug/medical device applications.

On the other hand, during the advisory committee intended to  hear experts' opinions on the safety measures of the existing products by FDA, and on the other FDA's activities, FDA explain the background, history and summary of FDA's measures and establishes some questions in order to hear the discussion among the committee experts. In some cases of meeting agenda the additional reports by the relating industries are presented to the committee.

In these cases FDA mostly provide "questions for discussion" or "discussion points" to the committee, and hear the committee members' comments expressed from their own expertise and point of view. FDA consider these comments afterward to take further actions on these matters.

4. Consolidation of FDA at the White Oak

  Why the FDA is scheduled to move into the site at White Oak, named for the Maryland State Tree, in the city of Silver Spring from Rockville and its vicinity? Why the FDA White Oak Campus is neighboring to the Naval Center? In order to answer these questions, this report explains the background of FDA consolidation and moving.

  While the Naval Surface Warfare Center with 662-acre military compound in White Oak was closing, the plan of consolidation of the FDA's previously scattered offices and laboratories and moving onto the former military site was designed.

  General Services Administration(GSA), the agency that owns and leases property for federal governments' buildings and offices, could make better use of real estate possessed by Navy and reduce the expenditure of FDA rental fee for space at 27 separate buildings and offices, especially laboratory space.

  In 1944 the federal government acquired the site at White Oak as the Naval Ordnance Laboratory, and then the facility later combined was renamed the Naval Surface Warfare Center. In 1995, as one of major reshuffling and shuttering of federal military bases, the White Oak warfare center was ordered closed. The Navy considered selling their property, but residents and officials wanted to keep it in federal use. It coincided with a plan to consolidate the FDA at another location in a suburb of Washington DC. Under pressure from Congress, the GSA agreed to consolidate and move the FDA to White Oak located approximately 5 miles north of Washington D.C., demolishing the old structures except for the former Naval Ordnance Laboratory, and to construct the new buildings in 130-acres site along the New Hampshire Avenue.

  The $1.15 Billion project of the FDA's consolidation is also expected to become the anchor of a new biotech hub just outside the Capital Beltway. The project includes 14 new buildings  interconnected with pedestrian bridges and pathways, and up to now 10 new buildings have been completed (No.1,2,21,22,51,62,64,66,31,32). The FDA began moving to White Oak Campus in 2003. At this time (year 2010), CDER is in Building No.21,22,51, CDRH in Building No.66, Laboratories in Building No.62,64, OC(Office of Commissioner) and ORA in Building No.1,31,32. Building No.2 is a Central Shared Use Building. The other buildings are under construction, and CBER will move by 2013. About 5500 FDA employees are now stationed in White Oak working, and the final total could ultimately grow to 8900.

  The GSA mainly requests to fund the FDA consolidation at White Oak in the Presidents FY budget. Residents and neighborhood activists argued that FDA consolidation means jobs for the people in this area and government-run research campus would spur other biotech and medical related development; for example, the Center for Science and Technology, county government-sponsored office park, and medical institution (hospital) with cardiac care center. The budget for FDA consolidation project is supported by them. (More than $137 million is included for the consolidation in FY2010 Financial Services Appropriations Bill)

  One of the most important consolidation merit mentioned among FDA staff members is that each employee in CDER or CDRH can easily face to face talk to other employee in different sections at the same or neighboring buildings.

  FDA rent the GSA-owned or GSA-leased space for facilities such as buildings at the White Oak Campus, and a part of the charges is covered by the User Fees. In addition to the scope of the Master Plan which is now 70% complete, FDA is working with GSA to secure GSA funding for facilities to support FDA's new Center for Tobacco Products at White Oak.

5. The United States Public Health Service Commissioned Corps  (PHSCC)

  Among the staff members working in the FDA, there are officers wearing the uniforms similar to the United States Navy with special devices, buttons and insignia reflect their specific service. They are commissioned officers of the United States Public Health Service Commissioned Corps  (PHSCC); so called one of the uniformed services. They serve on the frontlines in the Nation's fight against disease and poor health conditions.

  The seven uniformed services of the United States are : 1. United States Army(USA), 2. United States Marine Corps(USMC), 3. United States Navy(USN), 4. United States Air Force(USAF), 5. United States Coast Guard(USCG), 6. United States Public Health Service Commissioned Corps(PHSCC), 7. National Oceanic and Atmospheric Administration Commissioned Corps(NOAA Corps).

  The Army, Marine Corps, Navy and Air Force are administratively headed by United States Department of defense(DOD), the Coast Guard is by Department of Homeland Security(DHS), the Public Health Service Commissioned Corps is by Department of Health and Human services(HHS), and NOAA Corps is by Department of Commerce.

  The beginning of the PHSCC in its history was the creation of network of marine hospitals in 1798. They engaged in the Spanish-American War, World War I and II, and Emergency Response, such as California earthquake in 1994, attacks on September 11 in 2001, Hurricane Katrina in 2005, Haiti earthquake in 2010 etc.

  The mission of the PHSCC is "to protect, promote and advance the health and safety of the Nation, usually working in the HHS and other federal uniformed services and agencies, in the following ways; to help provide healthcare, to prevent and control disease, to improve the mental health, to ensure that drugs and medical devices are safe and effective, and food is safe, to conduct biomedical and health services research, and to work with other agencies on global health problems and their solutions.

  The PHSCC is an elite team of more than 6000 public health professionals, including :

  Physician, Dentist, Nurse, Pharmacist, Dietitian, Engineer, environmental health officers, Mental Health Specialist, Health Service Officers, Scientist/Researcher, Therapist, Veterinarian. (12 professional categories)

  PHSCC has own requirement for individuals to join the PHSCC according to the professional categories to serve within the federal agencies. It is different from the general employment by HHS.

  On the other hand, Commissioned Corps benefits include:

- Competitive starting pay that increases with promotions and years of service,
- Thirty days of paid vacation per year, beginning the first year,
- Tax-free housing and meal allowances
- Health care and dental care at no cost, and low-cost health care for family,
- A retirement plan
- Low-cost life insurance
- Access to military base lodging, recreational facilities,
- Shopping privileges at military base grocery and department store, etc.

  Can you imagine that the medical officers of the Ministry of Defense or Quarantine officers of the Japanese government are working in the Ministry of Health (MHLW) wearing their own uniform in the Kasumigaseki office building?

- To be Continued -

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Report from Washington D.C. Metro Area No.2 June 2010