Roger L. Williams
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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.
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.
