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Branding agency experts share what to know when it comes to legal, regulatory, and creative approaches in the complex drug-naming process, with its potential to shape a campaign’s success.
There was a Saturday Night Live skit a few years back in which a woman named “Lyrica” Williams was suing Merck for intellectual property theft, not only because of her own first name but also for her daughter “Seasonique Boniva’s” first and middle names. It’s not uncommon for the average person, or the gifted comedy writer, to wonder why on earth a drug is called what it’s called.
When prompted, people can usually come up with a few drug brand names that stand out in the realm of public consciousness for one reason or another. One of the first names that leaps to mind is Viagra. It’s all a bit subjective because different words, syllables, letter strings, and phonetic properties can elicit different reactions from different people, but the names that make an impact on the most people both through appearance and perceived meaning are the most impressive. The ability to conjure a range of emotion as well as a meaningful association is what advertising and branding are all about. With Viagra, there’s a theory the name comes from the Sanskrit word vyaghra, which means tiger1—a pretty good theory and certainly apropos. However, the word itself, stripped of its not-so-familiar Sanskrit meaning, evokes attributes like vitality, power, and hints of surging energy (perhaps because Viagra rhymes with the falls of Niagara).
It all starts with a chemical compound—one that shows promise as a treatment for a disease and may lead to the development of a new drug. Finding a lead compound is the first step in making a new drug to treat a disease safely and effectively. Every new drug intended to reach the market requires a pair of names: its non-proprietary/generic name (e.g., ibruprofen), and its brand name (e.g., Advil).
Whether designing a brand name or a generic name, the drug naming process is a long journey, often spanning years and multiple clinical trial phases—one that undergoes many formal reviews that extend beyond the walls of client and agency boardrooms and Zoom calls. There are legal, regulatory, and often linguistic review processes as most clients are looking for a globally-viable name. It requires a great deal of symbiosis between the drugmaker and its naming agency, while also considering patients, pharmacists, physicians, and other healthcare professionals (HCPs). The organizations holding the keys to approval are international regulatory bodies like FDA, European Medicines Agency (EMA), Health Canada, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), among others. The original aim of the regulatory bodies’ reviews, which is still of great importance, was safety. Not far behind safety were branding and marketing.
With the continued explosion of emerging biopharma companies (EBPs), there are many companies taking their first shot at drug development, the naming process, and subsequent marketing strategy. According to the IQVIA Institute for Human Data Science, the research and analysis arm of IQVIA, EBPs represent 65% of the total drug development pipeline, which is currently nearly 4,000 drugs (more than double the number in 2016).2 Additionally, 7% of the pipeline is being developed by EBPs in partnership with larger firms; meaning 72% of all drugs in the development pipeline have an EBP’s stamp on it.2 The road to launch is extremely complicated, and naming is just one hurdle along the way—albeit an exciting one. EBPs and large pharma companies should be prepared to engage with a good naming agency. Pharm Exec enlisted the expertise of three agencies to navigate the process: Leaderboard Branding, Eversana Intouch, and Brand Institute.
What separates pharma brand naming from other industries are the safety bumpers that restrict what a drug can be called. There are really no restrictions when it comes to naming outside of the pharmaceutical industry other than trademark considerations, which, according to World Intellectual Property Organization (WIPO), stood at 18.1 million new registrations in 2021,3 a number that increases every year.4 With drug naming, the review process is significantly more extensive.
Pharm Exec spoke with Maximilian Straka, director of drug safety at Leaderboard Branding, and former FDA Division of Medication Error Prevention and Analysis safety evaluator, and registered pharmacist, about the topic.
“The first thing to do is make sure that names do not have look-alike or sound-alike similarity to other marketed drugs using the FDA’s POCA (Phonetic and Orthographic Computer Analysis) tool,” says Straka. “POCA scores are part of the puzzle, but when evaluating them, you have to consider product characteristics like the dosage form, the dose, the strength, the indication, and dosing intervals—all of those product characteristics are the other half of a picture to a drug. It has its name, and then it has its product characteristics.”
In addition, prescription studies are conducted where names are handwritten in cursive along with the instructions. Agencies will send the samples out for interpretation by a number of practitioners. Sound-alikes are also covered by reading the drug names aloud to practitioners. It’s an exhaustive process, and for good reason. Every year, in the US alone, 7,000 to 9,000 people die as a result of a medication error.5 And hundreds of thousands of other patients experience but often do not report an adverse reaction or other medication complications.5
Take Velban (vinblastine) and Oncovin (vincristine) as an example. These are look-alike and sound-alike drugs listed by the Institute for Safe Medication Practices (ISMP). While the brand names are unique, the generic names can also cause issues. Fatal errors can occur when patients are given vincristine at a vinblastine dose.
In 2016, an issue arose when Takeda and Lundbeck’s Brintellix, a prescription medicine approved to treat major depressive disorder (MDD) in adults was deemed to cause confusion in the marketplace between Brintellix and the anti-blood clotting therapy Brilinta.6 Takeda and Lundbeck, in coordination with FDA, changed the name to market the drug as Trintellix in the US.
Internationally, each governing body has a process in place for naming drugs. The most active regulatory agencies—EMA, Health Canada, and MHRA—all have different processes for evaluating names. Naming teams at agencies like Leaderboard, Eversana Intouch, and Brand Institute consider existing POCA scores for European evaluation, and then incorporate linguists to research sections of the name to see if there are suggestive words (e.g., slang, and even names in history) or sounds that might have negative connotations across the different languages and cultures. Perhaps the most legendary example in the consumer world is the Chevy Nova. It’s a car that sounds new and shiny in the US, but if you’re expanding to Spanish-speaking markets, it translates to “won’t go.” The story, whether true or not, elucidates the point.
Rules around non-proprietary/generics have their roots in the late 1950s when Tennessee Senator Estes Kefauver discovered consumers—and many physicians for that matter—didn’t have any idea that two brand name drugs contained the same ingredient simply because there wasn’t a single generic name. He held very public, televised Senate hearings in 1959 resulting in a mandate requiring all pharmaceutical products to have one standard and universally agreed upon generic name that could capture a sense of the structure of the drug without being overtly long and unpronounceable.7 It marked a significant update to the United States Pharmacopeia, or USP, the dictionary that contains the list of generic drug names used by the United States Adopted Names (USAN) Council, which is the body that assigns these names.
Pharm Exec spoke with Suzanne Martinez, Eversana Intouch’s group director of strategic planning and resident naming expert, to learn more about the process. “In the generic name, the long and often more cumbersome names that sit below the brand name in a logo, the suffix is known as a stem, which defines the class of medication the drug is in,” says Martinez. “That stem cannot be embedded in your brand name because of potential confusion. I love generic naming because it’s a scientific formula for a doctor or prescriber, and you can get a little creative with the prefix.”
She believes that the pharma name is "a perfect example of where art meets science.” “Not only do you want to often communicate the science in the name, but it’s also the science of navigating all the regulatory challenges combined with the art of telling a story in the smallest, most succinct, most beautiful way possible,” adds Martinez. “It’s mission-critical to have that brand name serve as the first chapter of the story that you want to tell from a marketing perspective. But from my experience, it’s important that the brand name, as much as possible, sets you up for success in telling a strategic story, and a marketing story that is compelling for your different audiences.”
The long process of brand naming usually starts in Phase II or III clinical trials and begins with a kickoff meeting between the client’s project team and the agency’s team to discuss their asset and to scope out strategies and opportunities for the name—a completely original word in most cases. All agencies agree that it’s of the utmost importance to have the client with them on the entire journey. That way they understand how name creation aligns with their preferences based on the information of the asset they provided; what’s important to target audiences both on the HCP and patient/caregiver side; the background provided on the competitive landscape; and how their asset will fit into that landscape. The client is looking to discover that unique selling proposition and find where an opportunity lies in the market.
According to Scott Piergrossi, president, creative of Brand Institute, it’s a fact-finding mission with a lot of questions. “We usually prioritize our naming strategies: Is it a mechanism of action-associated name? Is it a specific attribute or benefit we want to suggest like improved tolerability or speed of onset? Do we want an association with the company name? Or do we want to paint an image or an aspirational association, maybe a name like Lunesta with its lunar imagery?” he tells Pharm Exec. “Who are we speaking to? If it’s an oncology drug, usually we’re speaking to the oncologists who are making prescribing decisions and recommendations. That is one reason why cancer drug brand names often highlight the product’s mechanism of action, because it’s a message that resonates with prescribing oncologists. If it’s more of a consumer-facing drug, sometimes it’s a benefit-driven name. If the nonproprietary name has been in the public for some time, perhaps we leverage elements of that nonproprietary name.”
Naming options can start at as many as 2,000 names and can be whittled down very quickly when running it through software, whether that’s FDA’s regulatory POCA database or proprietary software such as what Brand Institute uses that covers all obstacles, both domestically and abroad. Brand Institute sees its proprietary software as a necessity, viewing itself more as a tech company operating in the name game. And Piergrossi believes that the greatest value it can provide for its clients is clarity and certainty regarding whether or not an agency will approve or reject a name. More and more names are taken off the board and trademarked every year, so it gets more challenging with each passing year.
The second big meeting is a workshop where about 75 to 100 names are presented, and cross-functional participation is encouraged: creative, regulatory, legal, marketing, commercial, etc. It’s not about narrowing down to a couple of favorites, because there are bound to be disappointments once names have gone through trademark and regulatory review.
“It’s very much a subjective process so clients can’t help identifying some favorites, but we really encourage client teams to be more inclusive than exclusive, to only remove names the team just can’t live with during the early stages of the process,” shares Amy Baynard, creative director at Leaderboard Branding. “Later on, there are steps where we evaluate the benefits of a name and what it can bring to the table. In those steps, names can move up or down in the list of the team’s preferences—perhaps starting as a neutral in early reviews and then gaining momentum and rising to the top in further discussions and evaluations.
Baynard confides that a naming decision carries a lot of weight—the name isn’t meant to be around for a year or two, it’s intended to exist for a very long time.
Sometimes companies do all that work discovering everything they can about the client, the drug candidate, its mechanism of action, and the competitiveness of the market, and perhaps they decide to move forward with a “blank canvas” name.
For example, Prozac—which was introduced in 1987—is an extremely well-known brand. It had huge success as an antidepressant, was widely discussed in popular culture domestically, and was used by tens of millions of people worldwide. This period marked a time in naming history when pharma companies really started considering the branding advantages and nuances associated with drug naming. Although Prozac can be described as a blank canvas name, or one that doesn’t really hold any discernible meaning, it rolled off the tongue easily and was short and sweet at two syllables. One can see a potential positive association with the “Pro” prefix in Prozac, but when competitor names like Zoloft (1991) and Paxil (1992) enter the naming conversation, it’s clear they offer a bit more in terms of positive meaning and invoking emotion. The “loft” in Zoloft has a very positive association with shedding a weight one might be carrying, and the “pax” in Paxil conveys a sense of peace.
That said, there are a great deal of names already taken; therefore, using a blank canvas name is a strategy employed by naming teams today to limit the number of syllables and make it easily pronounced and memorable. Blank canvas names can also convey a certain tone without implied meaning and can cleverly differentiate themselves from other drugs in the same therapeutic space—drugs that all might have similarly tried to convey the scientific or other descriptive attributes of a name.
The drug brand naming process is a long one, so the earlier the manufacturer starts, the better. “We like to say, the earlier you start, in theory, the more shots you have on goal,” says Piergrossi. “If you have a name that you like commercially, but there are concerns from a regulatory standpoint, such as potential similarity with another drug name, you can submit that name and get feedback. Sometimes the name will get approved, sometimes it won’t, so we’re always well prepared with backups.”
The pharmaceutical name is just the beginning, it’s the springboard for the next creative team or agency to build strategy around the product and come up with compelling marketing campaigns to bring that brand to life in a very competitive market.
Fran Pollaro is Pharm Exec's senior editor and can be reached at firstname.lastname@example.org.