USP Convention to Reshape Organizational Structure and Goals

April 15, 2010
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Pharmacopeial Convention will hold its governance meeting next week in Washington, DC.

Next week, the US Pharmacopeial Convention (USP) will hold its governance meeting-which takes place every five years-in Washington, DC. Convention delegates will meet to set and revise the organization's policy and operational direction for the coming five years.

One agenda item for the meeting, which will take place April 21–24, is electing new members to the USP Board of Trustees. The Board will guide USP’s work between 2010 and 2015. Among the nominees are Timothy R. Franson and Douglas E. Rollins for president; John E. Courtney and Amy Porter for treasurer; and Duane M. Kirking, John W. Mauger, Mario Rocci, Jr., and Marilyn K. Speedie for trustee representing the pharmaceutical sciences.

The USP Resolutions Committee is expected to present nine resolutions to the delegates for adoption. Resolutions 2 and 3 call for strengthening the organization’s compendial role, including increasing and improving collaboration with the US Food and Drug Administration. “While USP and the agency have worked well together to respond to recent public-health crises, a closer, more forward-looking collaboration with FDA is needed to improve and expand the standards in the USP-NF,” states the proposed resolution. Goals would include closely and jointly scrutinizing USP monographs with the aim of anticipating and preventing public-health crises. Resolution 3 also suggests the establishment of a pilot program with FDA’s Office of Generic Drugs to focus on reducing abbreviated new drug application backlogs.

Resolution 5 focuses on increasing international harmonization and provides reference to a 2008 Pharmaceutical Technologyarticle on the ideal pharmacopeia. The full proposed resolutions are described on the USP website.

Delegates also will discuss proposed changes to the USP bylaws, including structural changes to USP committees and voting membership. One proposal recommends keeping only four of seven convention committees: the Council of the Convention committee, a new Governance committee, a Nominating Committee for Officers and Trustees, and a Nominating Committee for Council of Experts. Another proposal calls for reducing the number of trustees. All of the Constitution and Bylaws committee's proposed changes can be found on the USP website.

The four-day convention and symposium will feature speakers from the US Food and Drug Administration, including Commissioner Margaret Hamburg, the CEOs of the American Medial Association and American Pharmacists Association, and the director of the National Institutes of Health. Distinguished professors presenting at the event will include the University of Maryland’s Rita R. Colwell, the 2010 Stockholm Water Prize winner, and Johns Hopkins University’s Peter C. Agre, a Nobel laureate in chemistry.

Pharmaceutical Technology will publish a report about the convention in its May 2010 issue.