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Posted 14 August 2014 | By Alexander Gaffney, RAC,
US regulators are giving the pharmaceutical industry more time to weigh in on a draft guidance released in May 2014 that seeks to establish how new drug products are given their "brand" names.
The proprietary name for a drug is its "brand" name. For example, the erectile dysfunction drug sildenafil is marketed by Pfizer under the brand name "Viagra." In many cases, the brand name is easier to understand and recall for consumers and healthcare providers alike.
However, because brand names are generally shorter than the established non-proprietary name for a drug, it can be easier to get them confused with one another.
One example of this confusion was highlighted in the New England Journal of Medicine in May 2013, where researchers noted that many drugs approved in the last few years have started with the letters ”X” and “Z,” potentially confusing patients. To name a few from the last few years: Xofigo, Xtandi, Xarelto, Xalkori, Xgeva, Zaltrap, Zytiga, Zelboraf, Zioptan, and Zometa.
FDA regulators try to reduce the potential for confusion by approving final trade names submitted by companies, assessing them for similarity to other names. For example, if a company requested a proprietary name of "Simplus," but a similar drug was named "Simplos," regulators would almost certainly reject it based on the potential for mix-ups and errors.
In May 2014, FDA issued a new draft guidance document, Best Practices in Developing Proprietary Names for Drugs, intended to establish the process by which companies should name their drugs in order to prevent confusion between the new drug and other existing drugs.
Among the key points included in the guidance:
In addition, FDA said it would formally recommend that sponsors conduct real-world "simulation studies" to eliminate potential errors (such as confusion caused by messily-written prescriptions) and computational analysis of drug name similarity (known as POCA) to further eliminate potential similarities. (More on the guidance here.)
But now, after several months and requests for additional time, FDA has announced that it will give companies more time in which to comment on the draft guidance before it is considered for implementation.
Boehringer Ingelheim, the Consumer Healthcare Products Association (CHPA) and Procter & Gamble had all requested additional time to comment, according to FDA records.
Companies will now have an additional 30 days—until 15 September 2014—to comment on the guidance.
Federal Register Notice
Tags: Proprietary Name, Non-Proprietary Name, Guidance, Draft Guidance, Extension, Comment Period, Drug Naming Guidance
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