AAMC Reporter: April 2008

Viewpoint: "Setting the Standards of the Drug Industry"

Roger L. Williams, M.D., Executive Vice President and Chief Executive Officer, United States Pharmacopeial Convention

Would you be surprised to learn that public standards for drugs in the United States—quality standards for strength, purity, packaging, and labeling—are not developed by the Food and Drug Administration (FDA)? I have another surprise. The organization that creates these and other public standards—the United States Pharmacopeial (USP) Convention—is your organization.

Because many people are not familiar with the USP Convention, I am grateful for this opportunity to explain a bit to the AAMC audience about who we (you) are and what we (you) do. I'll start with a word about myself. I am CEO of the organization and also chair of our standards setting body, the council of experts. The first person to lead USP was a physician, Lyman Spalding, and so am I, trained as an internist and clinical pharmacologist. We are both a bit unusual—the intervening 13 leaders came more from the world of pharmacy and pharmaceutical sciences.

USP was founded in 1820 by physicians concerned about the quality of American medicines. The principal product of the USP Convention, then and now, is the United States Pharmacopeia (USP), going into its 32nd revision.

USP contains monographs for drugs—both ingredients and products—to support end product testing. In 1906 and again in 1938, Congress joined USP to FDA via the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act, and in other ways as well. This public-private partnership between USP and FDA does not exist in other countries, where pharmacopeias are usually part of the government. Despite this link in law—and in many state and international laws as well—the USP Convention remains a volunteer-driven, not-for-profit independent body, just as it was in 1820. Volunteers from AAMC and many other organizations lead USP's governance and standards-setting activities, and practitioners continue to make up the majority of USP's membership.

Through the contributions of practitioners and other volunteers, the USP Convention works to protect American physicians, patients, and consumers by helping to assure the integrity of the U.S. drug supply. Manufacturers regularly remove substandard medicines from the U.S. market to avoid possible incidents of adulteration—that is, the medicine as tested does not conform to USP's standards. These decisions are part of a series of risk-based safety nets that include ethical manufacturers, sound regulatory oversight, adherence to good manufacturing and distribution practices, testing to private and public requirements, and the availability of national standards from USP.

Safety nets can fail, however, and in recent months news stories of contaminated foods and medicines have shaken us all. In response to the rise of off-shore manufacturing (up to 80 percent of U.S. drug substances come from overseas), USP has established office and laboratory facilities in the countries with the largest volume of pharmaceutical manufacturing and export—India, China, and Brazil. USP is "on the ground" in these countries, working with their regulatory bodies and industry to improve the quality of ingredients and finished pharmaceutical products for their societies and for ours as well. USP is welcomed by these countries' governments and industry as an important ally.

Just like the medical profession and the people of the United States, the USP Convention has changed over the years. We now have a staff of 600 and more than 1,500 volunteers. In addition to the pharmaceutical standards published in the USP, we set standards for excipients in the National Formulary and also provide standards for food ingredients and dietary supplements, in the Food Chemicals Codex and a dietary supplement section of USP. And under your direction we do many other things.

For example, USP plays key roles in naming medications and setting standards for their packaging. And we have large medication error databases that help inform our standards. Medication errors arise from many factors, including sound-alike, look-alike drug names. A recent report on this was mailed early in March to each medical school dean and USP Convention delegate. Through our unique heritage, practitioners in the USP Convention have a special right. They can set the standards for the medicines they use in their everyday lives and practices. Such a special right easily could be lost, and in fact for many reasons, public standards do not exist for many of the medicines used today. Instead, there are only private standards created by FDA working with manufacturers, which may be updated only rarely. Also, there are emerging policies that reduce testing of medicines to any standards, either public or private.

Do you care that you are losing your right? If so, I urge you to become involved in the convention—get to know us and learn more about what we (you) do on behalf of your patients and consumers. And you have a very special opportunity in 2010 to send a delegate to the 24th USP Convention, just as your predecessors have done since 1820. Your delegate will get to elect USP's new volunteer leadership and tell me what direction USP should head in over the next five years. And with some luck, I will be there to welcome him or her with the greatest thanks and appreciation.

For more information, please visit the United States Pharmacopeial Convention Web site.

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