From Steve Dubansky, MD, SVP, Medical Director, Palio

In 1999 the Institute of Medicine published a report entitled To Error is Human: Building a Safer Health System. The report cited two major studies stating that from 44,000 to 98,000 patients die in hospitals each year as a result of preventable medicine-related errors. Moving with its usual alacrity, the government ordered the FDA to fix the problem in 2007. Congress, realizing the urgency, passed a law asking the FDA to offer a solution by September 30, 2010.

Yet, as noted by Stephen Barlas in P&T in October 2010, “…the FDA to date has no guidance, much less regulations, on the naming of drugs. Typically, when a drug company applies for approval of a new product, the FDA uses techniques such as human factors development and failure modes and effects analysis to determine whether the name is acceptable.”

Presently the agency and their agencies assure themselves that new drugs avoid drug names that have orthographic or phonologic similarities to drugs already on the market. Physicians have notoriously bad handwriting, and I assume that either we mumble more than the average person, or pharmacists on the other end of the line have a higher than normal prevalence of hearing loss.

The FDA reviews about 400 drug names a year and rejects about one third of them. The institute for Safe Medical Practices in conjunction with the Joint Commission publishes a LONG list of look-alikes or sound-alikes. Examples listed (http://www.ismp.org/) include:

In addition to look-alikes and sound-alikes, the agency now proscribes using names that imply efficacy (Paingona, Snotclyr) and dosing interval (Onlyonceawik). They will reject drug names that are misleading, including names that suggest the name of one or more but not all of the drug’s ingredients, or names that imply the drug is superior to a competitor. It wasn’t always this way: Lopressor (lower blood pressure), Coreg (help regulate heart rhythm) come to mind.

In Act II, Scene II of Romeo and Juliet, Juliette Capulet says to Romeo Montague, “Deny thy father and refuse thy name.” She suggests it because their love is more powerful than the feuding between the Montagues and Capulets. She follows with, “What’s in a name? That which we call a rose by any other name would smell as sweet.” She’s simply saying she loves Romeo and the Montague name is of little concern to her. For Juliette, a name is an artificial and meaningless convention, not nearly as important as the individual who bears it. For too many pharmaceutical companies, the names of their products are now becoming similar meaningless appellations.

There are appropriate restrictions on naming, but it seems as if the FDA has totally emasculated efforts to allow creative and meaningful product names. Some brands do seem aptly named (Femara has an obviously womanly tone) and Sonata (I can hardly say it without dozing off). But while many names are aptly named, many others are awfully named. You know what brands I’m speaking about. Their names seem to have been made up by a computer or a random drawing from a scrabble box, often nothing more than an incomprehensible and/or unpronounceable olio of letters.

Many might say that their names are integrally connected to the success of this or that blockbuster brand. I say “Phooey.” Brands are blockbusters most often because they are novel, first-in-class products in disease states with a real need and a high prevalence, or they have real (or perceived) advantages over their competitors. But a name that actually tells you something about the drug certainly can’t hurt sales. Lipitor, a #1 selling statin from start to patent expiration this year, wasn’t first to market, but it had great data and a name that surely implied “lipid” to any physician.

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