Power Of Proprietary Drug Names To Be Studied By US FDA
20 Jan 2020 | by: Brenda Sandburg | @brendasandburg
FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.
Can the proprietary names of prescription drugs sway perceptions about their efficacy and benefits and risks? The US Food and Drug Administration aims to find out. The agency's Office of Prescription Drug Promotion is proposing to conduct a study of whether proprietary names can be misleading. Entitled "Empirical Study of Promotional Implications of Proprietary Prescription Drug Names," the research will primarily focus on overstatement of the efficacy of the drug product. FDA announced the proposed study in a Federal Register notice scheduled for publication on 21 January. The agency said it is designed to answer two questions:
- How, if at all, do names that suggest the drug's indication affect consumers' and/or healthcare providers' perceptions of the prescription drug?
- How, if at all, do names that suggest an overstatement of the efficacy of the drug affect consumers' and/or healthcare providers' perceptions of prescription drugs?
FDA said it developed and pretested an extreme, explicitly suggestive name, such as CureALL, and a neutral name for two indications, high cholesterol and gastroesophageal reux disease. In the proposed study, approximately 500 consumers and 500 healthcare providers, including physicians, nurse practitioners and physician assistants, will see these pretested extreme and neutral names plus five target names per indication. They will answer questions about the names, before and after they have been told what each drug's indication is.
The agency said target names will vary so that some efficacy implications are more apparent than others and some will more clearly imply indication or benefits than others.
The study participants will be asked what health conditions they think the drug is used to treat, its perceived efficacy on a scale of 1 (not at all effective) to 7 (extremely effective), and how effective they think it would be in managing a specific condition on a scale of 1 to 6. They will also be asked about perceived severity of risk on a scale of 1 (not serious at all) to 7 (extremely serious) and if the benefits of the drug outweigh any side effects it may have on a scale of 1 (strongly disagree) to 6 (strongly agree).
The questionnaire will also ask them to rate their attitudes toward the drug on several scales (good to bad; desirable to undesirable; harmful to beneficial; positive to negative) and perceived attributes of the drug, e.g. friendly/unfriendly, modern/outdated, useful/not useful.
Promotional Names May Be Rejected
The agency said that to its knowledge this is the first study to provide a systemic investigation of a variety of proprietary prescription drug names. FDA reviews the proposed names of prescription drugs during the approval process, and OPDP is part of the review team, assessing whether a proposed drug would result in misbranding under the Food, Drug, and Cosmetic Act.
"OPDP focuses its misbranding review on identifying names that overstate the efficacy or safety of the drug, expand drug indications, suggest superiority without substantiation, or are of a fanciful nature that misleadingly implies unique effectiveness or composition," the notice states.
FDA usually challenges proposed proprietary names because of their similarity to the names of other products. For example, there was debate over GW Pharmaceuticals PLC's Epidiolex (cannabidiol) as FDA's lead name reviewer was concerned about its potential confusion with the existing OTC medication Pedia-Lax. (Also see "Epidiolex Almost Didn't Get Proprietary Name Because Of Confusion With OTC Pedia-Lax" - Pink Sheet, 26 Sep, 2018.)
And FDA rejected four proposed names for La Jolla Pharmaceutical Co.'s Giapreza (angiotensin II) due to confusion with marketed products and a product under review before finally accepting the fifth proposed name. (Also see "Giapreza Clinical Development Timeline" - Pink Sheet, 18 May, 2018.)
Scott Piergrossi, president of operations & communications at Brand Institute, said the agency also rejects names over their promotional nature. He cited two drugs that have different names outside the US. Johnson & Johnson's hair loss treatment minoxidil is sold as Rogaine in the US and Regaine elsewhere. And Roche's bone loss drug Boniva (ibandronate) has the brand name Bonviva (good life?) in much of the rest of the world. He cannot comment if the companies submitted the names used outside the US to FDA, but said they suggest the kind of claims the agency might take issue with.
Piergrossi said FDA has allowed a drug's indication to be embedded in the name. For example Novartis AG's gene therapy Zolgensma reflects gen (for gene therapy) and SMA (spinal muscular atrophy). Similarly, Ardelyx Inc.'s Ibsrela (tenapanor) includes the abbreviation for the indication of irritable bowel syndrome (IBS).
"Our clients want to embed as much in the name as they can but they have to do it subtly," Piergrossi said. As for FDA's proposed study, he said "I think it's a great idea because we need to have a better understanding of how the implied message in names effects prescribing and patient perception of a drug."
Decline In Research Projects
According to OPDP's website, it has completed 33 research projected evaluating direct-to-consumer and professional promotional prescription drug materials. Five additional projects are pending peer review and publication and 12 are in progress. That is the same tally the OPDP had in June 2019.
The number of studies has declined from the rapid pace of two-and-a-half years ago when FDA announced four studies in one month. (Also see "Rx Ad Studies Target Risk Info Location, Efficacy Framing, Oncology Products" - Pink Sheet, 9 Jul, 2017.) The Pharmaceutical Research and Manufacturers of America criticized the agency for the number and kinds of research projects it was initiating. (Also see "PhRMA Criticizes 'Exponential Pace' Of FDA Rx Drug Advertising Studies" - Pink Sheet, 13 Aug, 2018.)
Comments on the proprietary naming study are due 60 days from the date of publication in the Federal Register.