This content was current as of the date it was released. In science and medicine, information is constantly changing and may become out-of-date as new data emerge.
What’s in a Name?
A while back I wrote a popular Tribune article that was about how monoclonal antibodies (mAbs) are named, so I thought I would write next about how drugs get their brand names.
I will discuss the process of proprietary naming, for example the name Venclexta rather than the generic name, venetoclax.
Let me start by talking about the US Food and Drug Administration (FDA) since they have the final say on what drug companies are allowed to name their products.
What follows are recommendations taken directly from the FDA guidelines found in the publication “Best Practices in Developing Proprietary Names for Human Prescription Drug Products”:
- As far back as 1999, a report by the Institute of Medicine (IOM) described medication errors as a significant public health concern that accounts for 7,000 deaths per year in the United States.
- The IOM and FDA suggest brand names be chosen to avoid potential sound-alike and look-alike existing drug names by avoiding proposed proprietary names that are similar in spelling or pronunciation to existing proprietary names.
- The FDA recommends that proposed proprietary names do not incorporate any mention of an inert or inactive ingredient, because doing so may create a misleading impression that the ingredient’s value is greater than its true functional role in the formulation.
- Brand drug names should be easy to pronounce, as some prescription orders are still spoken.
- The FDA recommends that sponsors avoid proposed proprietary names that incorporate the company’s name. Since pharmaceutical companies typically make multiple medications, if each drug started with the company’s name you could see how there could be confusion amongst the products.
- A proposed proprietary name that alludes to a cure, panacea, or makes the suggestion of relieving symptoms associated with a chronic disease, would be considered “concerning” to the FDA. For example, this explains why the hair-regrowth product known as Rogaine was not allowed to be sold under the name Regaine in the USA. In most of the rest of the world, it is named Regaine. However, the FDA said not everyone will “regain” hair. So, in their judgment, that name suggested an excessive claim and was therefore rejected.
Next let’s look at the marketing side of naming drugs:
- A pharmaceutical company might pay a marketing agency up to $500,000 to develop a name for its medication.
- The naming process typically starts many years before it is time to submit the drug for FDA approval.
- Despite all that time, money, and effort, many proposed drug names are still rejected.
- It is common for drug names to start with the letters X, Q, and Z. Perhaps they sound more scientific?
- Q is used three times as often in proprietary drug names as it is in other words in the English language
- X is used 16 times more often
- Z is used 18 times more often
- The letters H, J, and W are used less often.
- Feminine products (such as birth control pills) tend to begin with softer sounds of the alphabet, such as the letters F, L, M, or S.
- Brand names of proprietary medications have been getting longer in an effort for each new drug to have a more unique name.
I bet you did not know there was so much involved in naming the pill you just swallowed!
Maybe later I will write on the naming convention and taxonomy for cancer drugs, such as the kinases that end with “ib”, such as ibrutinib, acalabrutinib, idelalisib, and duvelisib.
Stay strong. We are all in this together.
Brian Koffman MDCM (retired) MS Ed
Co-Founder, Executive VP, and Chief Medical Officer
Dr. Brian Koffman, a well-known retired doctor, educator, and clinical professor turned patient has dedicated himself to teaching and helping the CLL community since his diagnosis in 2005. He serves as the Executive Vice President and Chief Medical Officer of the CLL Society Inc.
Originally published in The CLL Society Tribune Q1 2021.