One World, One Name
by Isaac Wilson
August 2007
The goals of fostering public understanding and safety compel pharmaceutical companies to take care when naming nonproprietary drugs.
So what’s in a name? In the pharmaceutical world, the answer is: quite a lot. Although the process of giving trade names to pharmaceutical products is generally based on marketing principles—involving copious amounts of research and focus group testing—the process for giving a product a nonproprietary name that can be used worldwide is a much more complex and regimented process. And with an increasing number of new therapeutics in development, assigning unique and informative names to drug candidates is a critical step to ensure that the drug is prescribed, dispensed and taken properly once its released to the public.
The U.S. Food and Drug Administration (FDA) requires manufacturers to obtain a unique nonproprietary name for any drug that eventually will be marketed in the United States. Typically filed in the earlier stages of development, and only when an investigational new drug application already is on file at the FDA, applications for nonproprietary names are managed by the United States Adopted Name Council (USAN), an organization tri-sponsored by the American Medical Association, the United States Pharmacopeial Convention and the American Pharmacists Association.
According to Stephanie Shubat, director of the USAN program and secretary to the USAN Council, in Chicago, Ill., USA, the USAN began in 1961 as a way to distinguish drugs from one another without using trade names. “Our goal is for drugs to have one name throughout the entire world,” Shubat says. And although only responsible for drugs marketed in the United States, the USAN Council collaborates regularly with the International Nonproprietary Names program (INN), the World Health Organization sponsored group responsible for facilitating the selection and adoption of generic medication names globally. “Our relationship with the INN has expanded over the past few years due to the globalization of the pharmaceutical industry and the fact that it has become a smaller world in so many ways,” Shubat says.
Upon reviewing an application from a manufacturer, the USAN matches the chemical with an appropriate naming stem, and also takes into account factors such as the drug’s structural and molecular formula, and its pharmacological action. “These names have to convey information, so in a way they’re almost more difficult to come up than trade names,” Shubat says. “There are some guidelines, of course, and three-quarters of the name could be predetermined, but we have to pick the right one and we have to know what the drug is intended for and what it does.” Shubat says that the USAN reviews about 140 applications a year, and the group has adopted more than 800 names since 2000.
Once the USAN staff conducts some preliminary research to determine an appropriate name, the proposed name is sent to the five-member USAN Council who must unanimously approve the proposed name. Should the council recommend the proposed name, the USAN program sends an application to the INN for global acceptance. According to Shubat, around half of all applications submitted to the INN are sponsored by the USAN program, which offers a great benefit to the drug’s manufacturer. “The name has been thoroughly researched and companies know that any name they receive from the USAN will be pretty close to what they will get in the end,” she says. “[The USAN] recommendation carries a lot of weight, and both the INN and the drug manufacturers know that.” Shubat is also quick to point out that the USAN program won’t adopt a name unless it’s gone through the INN process.
Although the USAN has various naming schemes—for traditional small molecule drugs, monoclonal antibodies, gene therapy products and cellular therapy—the process can be tricky. “We’re creating a new language,” Shubat says. “And as more and more stems are created, it becomes harder to distinguish because they can’t be the same as others.” What is particularly challenging is naming the increasing number of bioengineered and recombinant derived products. “Monoclonals are so loaded with information that it’s hard to simplify the name down to four or five syllables,” Shubat says. “That scheme asks for the source, the target and the [monoclonal] ending. They [can] become very wordy and very long.” Nonetheless, the same technological advances that are helping to create these drugs also helps to constantly refine the nonproprietary naming schemes, she says. “We now have more knowledge about how these chemicals actually work and our newer stems actually reflect that knowledge.”
Quite simply, the aim of both the USAN and the INN naming programs is to communicate effectively with clinicians to ensure public safety and avoid obvious conflicts. “We’re trying to avoid as many medication errors as possible, and one name used consistently throughout the world will help achieve that,” Shubat says.
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