USP Board of Trustees Decisions
2013
Board Notes–Winter 2013
The USP Board of Trustees met at USP on February 10, 2013 in conjunction with the Mid-Cycle Governance Meeting in Carefree, AZ. This was the eleventh meeting of the 2010–2015 Board during this cycle. The joint meeting provided an outstanding opportunity for the Board to meet with all of the other volunteer bodies (Council of the Convention, Council of Experts, Convention Governance Committee) to report on activities from the first half of the cycle as well as coordinate the paths taken by each group leading to the 2015 Convention Meeting. In an effort to provide greater transparency to USP’s volunteer bodies, the first half of the Board meeting was open to observers.
Strategic Planning
The Board presented its revised Strategic Plan for comment by the Council of the Convention (CoC), Council of Experts (CoE) and Convention Governance Committee (CGC) members. A final Plan incorporating the comments of these groups is expected to be approved by the Board in May 2013 and available for public dissemination by the end of the fiscal year.
USP Foundation
Following initial discussions at the November meeting and subsequent discussions by the Operations and Governance Committees, the Board reviewed and approved an implementation plan for creating a foundation. The concept of a foundation envisions donor funding of public health activities outside of USP’s standards-setting arena. Further discussion will take place in upcoming meetings in order to approve organizational documents and other necessary actions with the goal of advancing funding for the new foundation in the FY’14 budget.
New Expert Committee
Management proposed a new Therapeutic Information and Formulary Support Expert Committee to develop the next version of the Medicare Model Guidelines and support other emerging practitioner-related information and decision making activities. This Expert Committee has been endorsed by the Council of Experts Executive Committee and was approved by the Board. The Expert Committee is expected to be formed in early March with meetings to begin in April or May.
Board Committee Activities
In a teleconference held prior to the Board meeting, the Audit Committee reviewed the annual IRS 990 Form submission and endorsed it, and the Board subsequently approved the submission unanimously. The Committee also reviewed the quarterly compliance report with the full Board, noting that no matters require further Board action at this time.
The Governance Committee reviewed removal recommendations from the Council of the Convention (CoC) of member organizations that have not named a delegate within the allotted time period. The CoC conducted repeated outreach efforts to encourage organizations to appoint delegates, however, two organizations failed to respond. The Committee and Board approved the removal. Each organization may re-apply for membership if so desired.
The Operations Committee reviewed and recommended some mid-year budget changes based on improved revenue which can be redeployed into existing and recently approved programs. The net effect of the revisions is minimal and maintains compliance with bond covenants and strategic reserve policy. No change was requested to the approved Success Sharing Plan metrics.
The Policy and Advocacy Committee conducted a teleconference to discuss the new Congress, emerging legislation, and the continued collaborative relationship with FDA.
The Executive Committee reported to the Board on its continuing work with senior leadership and an outside search firm to advance the CEO recruitment process.
Board Notes–Fall 2012
The USP Board of Trustees met at USP on November 4–5, 2012. This was the tenth meeting of the 2010–2015 Board during this cycle.
Strategic Planning
After important discussions regarding USP’s strategic direction and initiatives, the Board reviewed proposed changes to the Strategic Plan. A final Plan is expected to be presented to staff and volunteers by the end of the fiscal year.
International Activities
The Board discussed the continuing development of the Center for Pharmaceutical Analysis and Training (CePAT) in Ghana. An update was also provided on the status of the China site expansion, which is progressing positively.
Board Committee Activities
The Audit Committee reviewed the FY’12 financial audit conducted by Grant Thornton prior to the November 5, 2012 Board Meeting and recommended its acceptance by the Board. The Board unanimously accepted the audit report.
The Governance Committee conducted the annual Board Chair nomination and election process in advance of the November Board meeting. The Board unanimously re-elected Dr. Duane Kirking to a one-year term.
The Policy and Advocacy Committee conducted an informative meeting to discuss compounding, especially as it relates to the recent meningitis outbreak. As always, USP will provide neutral scientific expertise to Congress, press and the public on this and other topics. The Committee also discussed USP’s continuing interactions with FDA regarding monograph modernization, biologics, and other topics.
Board Notes–Summer 2012
The USP Board of Trustees met via WebEx on August 15, 2012. This was the ninth meeting of the 2010–2015 Board during this cycle and the second conducted as an electronic meeting.
Center for Pharmaceutical Analysis and Training (CePAT) Implementation
Following upon the Board’s May 2012 endorsement of the development of CePAT in Ghana, the Board approved a management proposal for a phased implementation approach. In Phase 1starting now, USP will establish a training facility in leased space in a building on the University of Ghana campus. This facility would support laboratory training for regulators and manufacturers in Ghana and other countries of the region as part of USP’s Global Health Impact Program (GHIP) headed by Patrick Lukulay. In Phase 2, USP might seek a commitment from the University for land for development of a larger, more permanent facility.
China Site Expansion Activities
Management provided an update to the Board regarding the expansion of the USP–China site. Although the site expansion is proceeding on schedule, there are unanticipated additional costs and additional funding is necessary to complete the project. The additional costs will be funded primarily through additional debt from JP Morgan (which will not change the interest rate or other terms of the loan), with the remainder funded through withdrawal from USP’s reserves. The existing bond covenants related to liquidity and debt service will still be comfortably met even with the additional debt financing.
The Board approved the increased borrowing and withdrawal from reserves for the USP–China site expansion, as well as the expenses associated with the Phase 1 CePAT site.
Board Committee Activities
The Audit Committee reviewed the quarterly compliance report and found no items for which further action was needed by the Board.
Management, on behalf of the Policy and Advocacy Committee chair, presented an update on USP’s policy statements on standards, continuing FDA interactions, and USP’s involvement with evolving legislation related to food safety and user fee programs.
The Governance Committee reviewed recommendations from the CEO and Convention President regarding appointments to the Council of the Convention. The Board approved the three appointments, which will increase representation from the government agencies section of USP’s membership as well as increase global representation on the Council. The Governance Committee also reviewed the timeline for the annual Board Chair election, which will be held prior to the November meeting. Finally, the Governance Committee discussed the possibility of appointing an additional member to the Board, and the potential areas of expertise which might be sought in a new Board member. The Board approved a management search for a final At Large Trustee for consideration first by the Governance Committee and then by the Board for appointment at its November 2012 meeting. The new Trustee is expected to attend the Midcycle Governance Meeting in February 2013 after staff orientation.
Board Notes–Spring 2012
USP's Trustees met at USP Headquarters on May 6–7, 2012. This was the eights meeting of the 2010–2015 Board during this cycle and preceded the May 17, 2012 Board Executive Committee retreat which began the Board's strategic planning process. The meeting also set the stage for Board approval of the final FY'13 budget. The following is a summary of the discussions and actions from the meeting.
Organizational Updates and Fiscal Year Planning
The Board received updates from staff on the continued progress of USP’s Science and Standards Division (SSD) and International Sites and Standards Division (ISSD). These divisions had reorganized earlier this calendar year. Management also provided updates on the current status and future planning (FY’13 and beyond) for all divisions within the organization in order to frame the preliminary budget for FY’13, which will be approved in June.
New Convention Members Approved
A total of 13 new and 2 returning organizations were approved by the Board for membership; among them, government agencies, an academic institution and several manufacturing and trade associations.
Board Committee Activities
- The Audit Committee reviewed the quarterly compliance report and found no items for which further action was needed by the Board.
- The Policy and Advocacy Committee discussed the status of user fee legislation, which is expected to conclude soon and will likely not be an item of additional focus until after the November election and resulting transitions. The Committee also reviewed and expressed support for a document summarizing USP’s key policies which USP intends to post on its web site.
- The Governance Committee reviewed recommendations from the Council of the Convention (CoC) for new Convention member organizations and forwarded its recommendation for approval to the full Board. The Governance Committee also reviewed the results of its periodic self-evaluation to ensure effective Board operations, and made recommendations to the full Board on items for follow-up.
Board Notes–Winter 2012
The USP’s Board of Trustees met at USP Headquarters on February 12–13, 2012. This was the seventh meeting of the 2010–2015 Board during this cycle. The following is a summary of the discussions and actions that occurred at the Board meeting.
Organizational Updates
Management provided updates on recent organizational structure changes, including changes in the Science and Standards Division to better coordinate and manage development of documentary and reference standards. Updates were also given on compendial activities and continued globalization as well as various initiatives such as diagnostics, spectral libraries, pharmacopeial education, and global comparator products (US Reference Listed Drugs). In connection with compendial activities, management explained current gaps in the compendia created by missing and out of date monographs and how the Medicines Compendium (MC) monographs might assist in updating USP–NF. The Board stressed the importance of filling these gaps, particularly in response to FDA requests.
Global Health Impact Programs and Development Activities
The Board received an update on the evolution of global health programs under the leadership of Patrick Lukulay, VP of Global Health Impact Programs. Trustees considered a proposal to establish a Center for Pharmaceutical Analysis and Training (CePAT) to serve Sub-Saharan Africa, and endorsed USP’s pursuit of philanthropic funding, under the leadership of Reema Jweied-Guegal, VP of Development.
Budget Revision and Success Sharing Plan Adjustments
The Board received and approved management’s revised mid-year budget that reallocated expenses to fund new staff and other expenditures in a variety of areas, including: new project management and executive secretariat staff to support the Science and Standards Division and the Council of Experts; expansion of laboratories and staff internationally to support the MC as well as modernization of USP–NF monographs; additional staff for the USAID PQM program; and increased IT staffing and expenditures.
Lease of Adjacent Building
The Board approved management’s request to enter into a lease of approximately 29,000 square feet in the building located at 12725 Twinbrook Parkway. Management noted that with the additional headcount requested in the budget revision, USP would need additional office and laboratory space to support USP’s continued expansion, until a new building can be constructed on the adjacent vacant land.
Bond Refinancing
The Board approved USP’s entering into a long-term direct placement arrangement with JP Morgan, under which the tax exempt bonds issued to fund the construction of the headquarters building will be held directly by JP Morgan and USP will pay interest at a fixed rate. This arrangement eliminates risks associated with USP’s current bond financing with Bank of America, including bank credit risk, renewal risk, and interest rate risk.
Other Board Committee Activities
The Audit Committee and Grant-Thornton reviewed the IRS 990 filing submitted for the previous year and the committee submitted it to the Board for final approval with no recommended changes. The Board unanimously approved the filing. The Audit Committee also reviewed the quarterly compliance report and found no items for which further action was needed by the Board.
The Governance Committee began its process of periodic self-evaluation to ensure effective Board operations. The Governance Committee also recommended the Board take the following actions based on requests from the President and Council of the Convention: provide advice and consent to add 7 new members to the Council of Convention (CoC); approve recent changes to the CoC’s Rules and Procedures; and approve removal of 61 organizations from the Convention membership for cause based upon their failure to name a delegate within the stated 12-month period. The Governance Committee noted that the 61 organizations consisted primarily of medical schools and state medical associations, which traditionally have not had a high level of participation in the Convention.
Board Notes–Fall 2011
The USP’s Board of Trustees met at USP Headquarters on November 6–7, 2011. This was the sixth meeting of the 2010–2015 Board during this cycle. The following is a summary of the summary of the discussions and actions from the meeting.
Chair Election
By a unanimous vote, the Board re-elected Duane Kirking as Chair for an additional one-year term. The announcement was made during the meeting by Dr. Marilyn Speedie, Chair of the Board Governance Committee which oversaw the nomination and election process.
Organizational Updates
The Board received updates on a number of topics, including recent changes to the organizational structure. The Board also met Dr. Praveen Tyle, USP’s new Chief Science Officer and greeted Dr. V. Srini Srinivasan, who leads USP’s non-US sites and is responsible for the USP Medicines Compendium (MC). Management also presented preliminary five-year financial projections and discussed the factors influencing USP’s future growth and accomplishments.
Site Expansion
The Board approved Management’s proposal to expand the USP–China site. The expansion would significantly increase USP’s currently constrained laboratory capabilities and allow for further pursuit of activities related to the MC and a potential Center of Excellence for Foods in China. Management also received approval to acquire a 3.46 acre parcel of land adjacent to the USP-India site for future expansion.
Spectral Libraries
The Board approved additional funds for work on the spectral libraries initiative based on the successful pilot project implemented under the leadership of Ed Zhao. These funds will be used to support the next phase of this initiative, which is the development of the infrastructure to house spectral libraries.
Additional Expert Committees to Support the Medicines Compendium (MC)
The Board also approved the creation of additional Expert Committees to support work in publishing monographs in the USP MC. The formation of these committees, in addition to the current Expert committee supporting the MC in India, will provide representation by experts in other regions for the development of standards for articles marketed outside of the United States.
International Travel
The Board received positive feedback from Trustees and staff who attended the September inauguration of the expanded USP–India site. Board members Dr. Duane Kirking, Dr. Rene’ Bravo, Mr. Tom Temple and Dr. Gail Wilensky attended on behalf of USP. Mr. Tom Menighan was also able to attend some of the USP events (even though he was representing the American Pharmacists Association at the FIP Annual Meeting in Hyderabad).
Committee Decisions
The Board unanimously accepted the Audit Committee’s final financial audit report for FY ’11. The audit resulted in no findings for which any action or response from management was necessary. The Board also approved the committee’s recommendation to add guidelines to the existing Whistleblower Policy that will enhance the process for reporting and investigating whistleblower concerns.
The Governance Committee reviewed recommendations from the Council of the Convention for new Convention member organizations. A total of 28 organizations, including government, standards setting, academia, trade association, and public interest organizations, were approved by the Board for membership.
The Board conducted two informal sessions—one on practitioner opportunities and another on Board engagement in policy and advocacy. Following these discussions, the Board recommended strengthened outreach to understand practitioner and patient challenges where USP could contribute and concluded that the current Policy and Advocacy Committee should continue as a means of generating key topics for further Board consideration.
Board Notes–Summer 2011
The members of USP’s Board of Trustees met by webconference on August 23, 2011. This was the fifth meeting of the 2010–2015 Board during this cycle. The following is a summary of the discussions and actions from the meeting.
Organizational Updates
The Board received updates on several of organizational topics, including the composition and demographics of the Council of Experts, and changes to the staff organizational structure. Management also provided an update regarding the development of a plan for expansion of the China site. This proposed expansion will be discussed in detail at the November 2011 Board meeting.
Upcoming India Inauguration
USP Management provided an overview of the activities planned for the India site inauguration. Board members Dr. Duane Kirking, Dr. Rene’ Bravo, Mr. Tom Temple and Dr. Gail Wilensky will attend the inauguration and International Pharmaceutical Federation (FIP) meetings in Hyderabad, and Mr. Tom Menighan will represent his own organization (American Pharmacists Association) at FIP meetings and attend USP celebrations as his schedule allows.
Board Notes–Spring 2011
USP’s Board of Trustees met at USP Headquarters on May 22–23, 2011. This was the fourth meeting of the 2010–2015 Board and its Committees during this cycle. The following is a summary of the discussions and actions from the meeting.
Board Appointments
The Board appointed four new trustees to serve until 2015. Two of the new trustees will replace resigning Board members: At-Large Trustee Frank J. Sasinowski, M.S., M.P.H., J.D. and Medical Sciences Trustee Lisa A. Cooper, M.D., M.P.H. The Board appointed two additional trustees to provide leadership in newly evolving areas for the organization. The Bylaws give the Board authority to fill vacancies and add up to three At-Large Trustees during the cycle. USP’s four newest trustees are:
- Medical Sciences Trustee
- Michael D. Maves M.D., M.B.A., Executive Vice President and CEO of the American Medical Association and a speaker at the 2010 Convention
- At-Large Trustees
- Robert L. Buchanan, Ph.D.,Professor and Director, Center for Food Safety and Security Systems, University of Maryland
- Thomas E. Menighan, B.S.Pharm., M.B.A., Sc.D., FAPhA, Executive Vice President and CEO of the American Pharmacists Association and a speaker at the 2010 Convention
- Jeffrey L. Sturchio, Ph.D., President and CEO of the Global Health Council
Preliminary Budget
The Board reviewed and endorsed the preliminary budget for FY’12. Although official approval will not take place until June, the Board carefully considers the budget each spring in order to identify any additional items for consideration before the beginning of the fiscal year.
Strategic Planning and Joint Governance Activities
The Board approved minor revisions to the 2005–2010 Strategic Plan and endorsed the Plan. The Board also endorsed a mid-cycle (2013) joint meeting of USP’s governing bodies to discuss and provide input on further Strategic Plan revisions. The groups also will review progress on Convention resolutions, Council of Experts work plans, and look ahead to possible activities for the 2015 Convention and the 2015–2020 cycle.
Board Committees
The Audit Committee reviewed compliance activities for the past quarter and also met with representatives from Grant Thornton to prepare for the annual financial audit. The Governance Committee finalized its recommendations for Board member appointments and recommended the addition of the Grocery Manufacturers Association as a new member of the Council of the Convention.
Under the globalization plan endorsed by the Board, USP is considering establishing Centers of Excellence at its international sites that could provide products and services to meet local and regional public health needs. USP also recently launched its Technical Assistance Program, which provides reference standards at reduced or no cost to official medicines control laboratories in developing countries. Recognizing that USP’s traditional financing model (the sale of books and reference standards) is not available to support these international public health activities, the Board discussed the possible creation of a mechanism for obtaining development funds to support these activities.
Board Notes–Winter 2011
The members of USP’s Board of Trustees met at USP Headquarters in Rockville, MD, on December 5, 2010 and February 13–14, 2011. These were the second and third meetings of the 2010–2015 Board and its committees during this cycle. The following is a summary of the discussions and actions that occurred at the December and February Board meetings.
Globalization
The Board and management discussed USP’s expanding global presence, including international sites, cooperative agreements, annual meetings and outreach activities around the world. The Board unanimously approved a resolution endorsing globalization plans, with the understanding that specific actions and financial expenditures to implement the plan will come to the Board for approval as part of the annual budget or other specific requests.
Creation of a New Council of Experts Committee
As an extension of the existing non-US monographs initiative, USP is planning to develop an online compendium of monographs for articles marketed outside of the United States. The USP Medicines Compendium (MC), will be supported by a newly established committee of the Council of Experts. The MC Monograph Development Expert Committee will be made up of members of the scientific community in India working with staff liaisons and laboratory staff at the USP–India site. It will follow the Rules and Procedures of the USP Council of Experts. The Board approved the formation of this new Expert Committee on the recommendation of the Chair of the Council of Experts and following a consultation with the Council’s Executive Committee, as required by Article VII, Section 4 of USP’s Bylaws.
Purchase of Land Adjacent to India Site
The Board approved the purchase of a parcel of land in the IKP Knowledge Park, adjacent to the USP–India site in Hyderabad, India. The acquisition of this land was based on the value of the land investment, although no specific plans are in place for expansion beyond the construction of USP–India's new building.
Rules and Procedures Approval, New Council of the Convention Members
The Board approved the Rules and Procedures of the Council of Experts and the Council of the Convention. The Board also approved two new Council of the Convention members—AARP and the National Organization for Rare Disorders—to provide additional consumer expertise to this group.
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