Searching for marketability and safety
What’s in a name? Would a drug by any other name work as well?
Certainly, experts agree. But a poor choice of name could affect the marketability of the drug, its safe use, and even Food and Drug Administration (FDA) approval. With the stakes so high, naming drugs has become an elaborate process.
Developing a competitive drug name involves target audience market research and trademark and linguistic screening, said James L. Dettore, president and CEO of Brand Institute Inc. in Miami. The company is one of the largest developers of brand names and identities in the country. Dettore estimates that approximately 60 percent of his company’s business comes from pharmaceutical companies.
“You’re hoping to come up with something that’s catchy and memorable and will stick in people’s minds,” said John Siegfried, MD, deputy vice president for science and regulatory affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA). “It’s no different than naming cereals or naming motor oils. You want something that’s going to have public appeal and yet gives some indication of the usefulness of the product so there will be name recognition.”
But short, catchy names that consumers remember don’t always make pharmacists’ jobs easier. “It’s getting more difficult now because it appears that it’s getting harder and harder to come up with something unique. Because of that, we seem to be getting drugs that are very easily confused,” said Craig Bell, RPh, a manager at Armstrong Pharmacy in San Antonio. He said that Warner-Lambert’s new insulin enhancer Rezulin (troglitazone) has the same name as an anti-acne lotion that was on the market about 20 years ago but is no longer available.
Other product names may be similar enough to cause confusion, particularly with phone orders or hastily scrawled prescriptions. “When they go to using UPC [universal product codes] on bottles and things like that to ensure that misfills are not going to occur, you know that there are a lot of drugs that look and sound very similar to each other,” Bell said.
Sometimes the confusion is more than just a nuisance. Though drug manufacturers say that safety is a top priority in choosing a name, similarities in trade names can lead to medication errors. The FDA ordered Merck & Co. Inc. to change the name of its gastrointestinal drug Losec (omeprazole) because it kept getting confused with the Hoechst-Roussel antihypertensive medication Lasix (furosemide), causing adverse reactions in patients. So Losec became Prilosec.
According to a 1993 medication error study by the Physician Insurers Association of America, communication problems in prescription writing accounted for 11.3 percent of all medical errors in the claims studied, more than any other factor. To minimize such errors, the FDA established the Labeling and Nomenclature Committee (LNC) in 1990 to review proposed trade names. In addition to preventing similarities in drug names to improve safety, the LNC strives to block manufacturers from using fanciful or misleading names.
William Purvis, director of the FDA’s advertising and promotional labeling staff, was part of the LNC when it reviewed Pharmacia & Upjohn’s submission for the baldness treatment minoxidil under the name Regaine, its international trade name. He and others at the FDA thought the name was misleading because hair gains attained by using the product were lost when use was discontinued. “So Regaine is suggestive of a promise that you’re going to get something back that you lost, when in fact, you’ll only keep it as long as you use it,” Purvis said. The manufacturer appealed the decision to reject the name and lost. The drug’s name was changed to Rogaine in the United States.
Since its formation, the LNC has reviewed more than 600 drug names. Initially, only about one-third of drug name submissions were accepted. Now, proposed brand names are accepted more regularly as manufacturers learn what the FDA will approve. “I would estimate that [in the past year] somewhere between 70 and 75 percent of the names are acceptable, with about 15 to 20 percent being acceptable with concerns, and the remaining 5 to 10 percent being unacceptable,” Purvis said.
Often drug manufacturers seek help from companies like Brand Institute. Dettore said that his company generally starts with brainstorming to choose a product name. Ideas come not only from the pharmaceutical company, but from physicians, pharmacists, nurses, and consumers, and from Brandchat, an Internet chatroom run by Brand Institute. “We also have our own creative team that takes those ideas and fine-tunes them into names that are more appropriate for that specific product in that specific market,” Dettore said.
He said that the most effective names in the pharmaceutical industry are generally 10 letters or less and three or fewer syllables. “In most cases, companies are now leaning away from names that are compound-driven and derived,” Dettore said. Sometimes they go with a name that suggests the benefits of the drug or site of action, he said. Other times, they select a completely arbitrary name, a blank canvas on which they can create a marketing campaign.
Once a name is chosen, the scrutiny begins. Trademark attorneys search for conflicts with existing products. Linguistics experts screen more than a dozen languages for negative connotations and pronunciations of the name. Others test the name for recall, preferences among potential users, and possible misinterpretations.
“We’re the only one in the industry who has a methodology for [testing for] prescribing and dispensing medication errors, whereby we actually test names on their viability of how well pharmacists can interpret and spell those handwritten scrips [from physicians] or telephone orders,” Dettore said.
The whole process usually takes two to three months, although it depends on the client, Dettore said. Brand Institute only had four weeks to work on Redux (dexfenfluramine), including market research, creative development, trademark research, and linguistic screening, he said.
Costs can range from $50 to $100,000 for developing a drug name, not including legal fees, Dettore said. Siegfried thought that estimate was low, but agreed that the cost of naming a drug is a small percentage of the total expenditure of developing a drug, which he said can run to several hundred million dollars.
As scientific as the process of naming drugs has become, it’s still a roll of the dice. “There are no absolutes as to a totally safe name in the way it’s constructed,” Dettore said.