FDA Launches Study Into Drug Naming Guidelines
Federal drug regulators are launching a new study, which seeks to help evaluate whether brand names assigned to certain medications are too suggestive or imply overstated effectiveness for doctors and consumers.
In a Federal Register notice posted on March 16, the FDA proposed a prescription drug name study that will look at whether extreme or suggestive drug names give patients and healthcare professionals a preconceived notion about a drug’s ability to cure or treat a medical condition.
During a new drug’s naming process, manufacturers will typically hire branding agencies to help create a name for the medication’s brand name, which will be used in marketing materials.
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The names are then proposed to the FDA for final evaluation to ensure the medication name is not too similar to those already on the market, and to avoid the risk of medication mistakes and confusion, among other preset criteria. However, the agency has expressed concerns that certain prescription drug names may overstate the efficacy or safety of the product, suggesting it as superior to the competition, or are fanciful in nature, which can imply unique effectiveness that other drugs do not feature.
In the proposed study, the FDA plans to interview 500 consumers and 500 healthcare providers, including doctors, nurses, and physician assistants in the drug name test. The agency will use five fictitious name suggestions created by a linguist that include neutral sounding drug names such as Zerpexin, while some will be an “extreme, explicitly suggestive” name such as CureFlux.
Participants will answer questions before and after they are told what the drug is intended to treat to determine whether drug names which overstate the efficacy affects consumer perception. The interviews will be conducted by the Office of Prescription Drug Promotion (OPDP) and is reportedly the first empirical study of its kind.
The announcement of the study comes just months after the FDA issued a new Best Practices in Developing Proprietary Names for Human Prescription Drug Products guidance in December 2020. The guidance was offered in an effort to minimize name-related medication errors which have resulted in several safety advisories after patients were given incorrect medications, which could pose serious and potentially life threatening health consequences.
When approving names, the FDA creates a list of names that could be confused with the proposed drug. During the process the FDA reviews spelling, pronunciation in different accents and how the name will appear written by hand in different handwriting samples. More than 22 pages are written on guidelines for drug name approval.
More than 400 proposed drug names are reviewed every year. The FDA rejects about one-third of them, typically due to concerns they will confuse consumers. Generic drug names are monitored by the U.S. Adopted names Council.
Renewed attention has been focused on drug names in recent years, after a few situations where confusing names resulted in medication mistakes that exposed consumers to serious health risks.
In 2011, the FDA warned about the risk of confusion between the Parkinson’s disease drug Requip and the antipsychotic medication Risperdal, following more than 226 reports of problems where individuals took the wrong drug, including at least five cases that resulted in patients being hospitalized.
The FDA approved a name change for the heartburn drug Kapidex in 2010, after receiving reports of pharmacists confusing it with other drugs, such as the prostate cancer drug Casodex or the morphine-based pain killer Kadian.
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