Insider Solutions: A New Direction for USP?

With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.
Nov 02, 2009
Volume 33, Issue 11

Susan J. Schniepp
The United States Pharmacopeia (USP) held its Annual Scientific Meeting in Toronto in September. At the meeting, USP released a series of whitepapers (all seven are available at that discuss the role the pharmacopeia's public standards play in an "era of healthcare crisis and reform" (1, 2).

(Stockbyte/GETTY IMAGES)
USP's Council of the Convention (CoC) assembled the whitepapers. Established in 2005 to facilitate and educate United States Pharmacopeial Convention (USPC) representatives, CoC is responsible for examining the purpose, role, and composition of USPC membership, including voting procedures. These responsibilities are critical to defining a revision cycle. A revision cycle is defined as the five-year period between conventions in which the Expert Committees set standards (i.e., develop and revise monographs and general chapters) of the USPC. Convention representatives are responsible for selecting USP committee chairs and voting on the resolutions that will define USP's strategic direction. The 2010 convention will take place Apr. 21–24, 2010, in Washington, DC, and the 2010–2015 revision cycle will commence on July 1, 2010.

A bit of history

Envisioned as a liaison between USP's Council of Experts, scientific staff, and convention members, CoC also holds responsibility for reviewing with key stakeholders the progress on resolutions adopted at annual meetings. These annual interactions are expected to result in a more educated membership that is prepared to deal with the complex issues facing USP when all parties meet at the convention every five years. USPC meets every five years to set the goals, objectives, and direction for USP during the upcoming revision cycle.

USP was founded in 1820, long before the pharmaceutical industry came into existence. At that time, medicines were prepared by pharmacists, making them the pharmaceutical manufacturers of the day. Because of this and other historical developments, USPC membership is based heavily in the pharmacy community. The pharmaceutical industry is represented in USPC by trade organizations such as the Generic Pharmaceutical Association, the Parenteral Drug Association, and the Pharmaceutical Research and Manufacturers of America. Each member organization sends a representative to the convention, where he or she is expected to vote on changes to the USP Constitution and bylaws, select (by vote) the members of the Board of Trustees as well as the Council of Experts Chairs, conduct business meetings, debate, and vote on resolutions.

The upcoming convention

Fast forward to September 2009 when CoC released seven whitepapers at the USP Annual Scientific meeting. The seven papers address areas of interest for USP (e.g., food ingredients and dietary supplements), but three are of special interest to the pharmaceutical industry, as summarized below.

Whitepaper: "USP's Role in Setting Enforceable Quality Standards for Medicines." The content of this CoC whitepaper discusses USP's ongoing mission to establish standards for all pharmaceutical products approved for sale in the US. According to this paper, USP's monograph universe consists of 5720 articles. Of these 5720 products, 1960 (34%) do not have monographs and 583 (10%) have monographs that do not meet current standards and need to be updated. The paper justifies the out-of-date monographs by stating that, "USP has no way to compel information and receipt of candidate materials to support a public monograph." The paper further indicates that the US Food and Drug Administration's Freedom of Information Act prevents USP from obtaining the necessary information to establish monographs from companies' new drug and abbreviated new drug applications. The paper explains some of the efforts undertaken to establish missing monographs, including establishing performance-based monographs (3) and developing monographs from existing sources outside the US. In addition, CoC explores USP's potential role in supply-chain management to prevent economically motivated adulteration through the convention's standards-development process.

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