Inside USP: Positioned for Growth

In a unique gathering that occurs once every five years, the diverse membership of the US Pharmacopeial Convention (USP) gathered for three days in late April to chart a course for the organization for the next cycle—2010 to 2015. A host of issues were debated, and decisions were made that will impact industry and compounding professionals as well as regulatory agencies, patients, and practitioners in the coming years.

Roger L. Williams

Chief among these issues was the passage of a series of resolutions to guide the organization's work, and the election of a new Council of Experts—the individuals responsible for developing the quality standards for pharmaceuticals published in the United States Pharmacopeia–National Formulary (USP–NF), in addition to USP's other compendia. The convention also elected a new USP Board of Trustees and concluded major changes to the organization's fundamental rules, now termed USP's Bylaws. A group of leading health experts spoke to the critical nature of the work of USP, particularly in light of the rapid internationalization of the pharmaceutical industry.

The USP membership dates back to 1820, and has long served as a distinctive event that brings together top minds from different areas—schools of medicine and pharmacy, regulatory agencies, manufacturer and related trade associations, consumer organizations, and many others. This year, the meeting had a real international feel as USP hosted official observers from around the world. This is a fitting evolution for the event, reflecting the reality of today's rapidly globalizing world, in which medicines and their ingredients as well as foods and their ingredients are sourced heavily from overseas. This globalization, of course, has brought both opportunities and challenges—an area that US Food and Drug Administration Commissioner Margaret Hamburg discussed in her remarks to the USP membership.

Dr. Hamburg noted that new approaches are essential to ensuring that medicines and foods consumed by Americans every day are safe and quality-assured, particularly because FDA is unable to inspect all imported goods as they come across the border. She pointed to a staggering statistic: an estimated 20 million shipments of FDA-regulated imports are expected to come into the US this year from more than 150 countries. Just 10 years ago, that number was closer to 6 million. This is an area where partnerships such as those between FDA and USP are key, she said. Dr. Hamburg referred to three joint initiatives in which FDA and USP have agreed to expand efforts to promote the safety, efficacy, quality, and performance of current and new drugs, as outlined below.

First, physical reference-standard candidates that are controlled substances will be jointly assessed. Second, in efforts to combat economic adulteration, FDA and USP will exchange information on hand-held device applications designed to screen drugs for adulteration or contamination and explore ways to integrate the requirements of those new technologies into USP's documentary standards. Third, FDA will assist in the development and modernization of USP monographs, leading to enhanced tests and assays to better assess and characterize drug ingredients and products—the medicines that practitioners and patients use in everyday life.

Speaking about modernizing monographs, Dr. Hamburg cited the heparin adulteration episode of 2007–2008, which underscored the fact that such modernization is one of the most pressing areas for FDA and USP to work together. Dr. Hamburg stated that the incident

"can be used as a model for how to move forward proactively to modify monographs in a way that they identify counterfeited or intentionally adulterated products before they enter the healthcare system. Now, we must jointly identify drug ingredients and products that would benefit from an up-to-date monograph ... starting with those that have the greatest impact on public health."

Of course, this is an issue of critical importance to industry.

Dr. Hamburg's remarks preceded a vote by USP delegates on a series of resolutions that will guide the organization for the next five years. One resolution aims to strengthen USP's relationship with FDA, by working with the agency 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 US. Other adopted resolutions are of interest to the pharmaceutical industry as well. One involves strengthening USP's focus on core compendial activities by working collaboratively with academia, industry, regulators and other stakeholders, and by using a robust quality management system within USP and its Council of Experts, to ensure relevant, timely, and accurate public standards. Another focuses on strengthening and expanding harmonization efforts by working with pharmacopoeias, industry, academia, regulators, international organizations, and other stakeholders to develop global standards. Additional resolutions focused on issues such as standards for compounded medicines, dietary supplements, and food ingredients.

Other important work relevant to industry included the election of the USP Council of Experts, which will be responsible for establishing the standards for medicines, dietary supplements, and food ingredients of USP during the next cycle. These standards help ensure the identity, as well as the strength, quality, and purity of products and ingredients in the US and in countries where USP standards are used. Members of the Council of Experts serve as the chairs of 20 individual USP Expert Committees, which focus on standards development in specialized areas such as small-molecule medicines, biologics and biotechnology, and general chapters. The independent, scientific experts who are responsible for developing new and revising existing quality standards to reflect modern, relevant and up-to-date science are truly the backbone of USP.

The 2010 meeting continued the tradition of collaboration that is the very foundation of the event (and of USP). Overall, the nine resolutions—all adopted—further reinforced the need for cooperation in light of modern challenges by calling on USP to work with industry and others to promulgate the best possible standards for medicines and ingredients. As in the past, USP will continue to seek the expertise of industry through participation in Expert Committees, acquisition of new standards, and other activities. The organization looks forward to another five years of working together to advance public health through quality medicines.

Full information about the convention, including resolutions, key reports and presentations, and a list of the Council of Experts' members, is available at www.usp.org/meetings/convention/.

Roger L. Williams is chief executive officer of the US Pharmacopeial Convention in Rockville, MD, rlw@usp.org.