By some estimates, it is not unusual for pharmaceutical companies to spend anywhere from US $200,000 to $500,000 per product selecting the “best” brand name for a drug. While this might not seem like a lot compared to the roughly $800 million it can cost to get a drug from the drawing board to market, a good brand name often can be the difference between a blockbuster and a flop because a good name leads to significantly increased consumer recognition and sales. The same is true for medical devices, albeit to a lesser degree. And while the “wrong” name will surely hurt a manufacturer’s bottom line, it can also cause regulatory issues with the Food and Drug Administration (FDA). This article explores the government oversight of the naming of drugs and medical devices in the United States and offers practical tips on how to select names that pass regulatory scrutiny.
In the United States, drugs are regulated by the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act). See 21 U.S.C. § 301 et seq. The FD&C Act, originally passed in 1938 and subsequently amended on numerous occasions, gives the FDA the authority to oversee the safety of food, drugs and cosmetics. As part of its objective, the FDA tries to prevent drugs with confusingly similar names from being marketed.
As one might expect, the confusingly similar drug names can cause real danger. The FDA reports that in the United States, medication errors are estimated to cause at least one death every day and injure approximately 1.3 million people annually. Approximately 12.5 percent of medication errors are attributed to name confusion. (More information here
.) Despite the FDA’s efforts, drugs with similar names sometimes do gain approval. (To view some examples, access the Institute for Safe Medication Practices list of commonly confused drug names
.) To combat post-approval confusion, the FDA monitors drugs after approval and reviews about 1,400 medication errors per month. It can order changes to brand names or product labeling based on reports of confusion in the marketplace.
There are three distinct names given to every drug: a chemical name, a generic name and a proprietary name. A drug’s chemical name typically is a long, cumbersome name that specifies its molecular structure. It is chosen by the manufacturer and used primarily by researchers—it is rarely used in practice. A drug’s generic name is selected by the United States Adopted Names Council (USANC). For each new drug, a drug company submits up to three possible names to the USANC during clinical trials, typically during Phase I or Phase II clinical trials. The coining of generic names is subject to the USANC’s name guiding principles, which include both general principles and specific nomenclature rules. The USANC reviews and selects a generic name based on its usefulness to healthcare providers, patient safety, adherence to the USANC’s nomenclature rules, absence of conflicts with existing names, suitability for use internationally, ease of pronunciation and other factors. Both chemical names and generic names are in the public domain and not subject to proprietary trademark rights.
The third drug name, the proprietary name, is typically the trademark used by the first manufacturer of the drug. There are many more than 30,000 drugs registered as trademarks in the United States. That number is estimated to be as high as 150,000 in Europe.
In the United States, proprietary names are reviewed by the FDA and the U.S. Patent and Trademark Office (USPTO). Because of the volume of existing names and the associated challenges in finding a unique name, drug makers typically file intent-to-use applications with the USPTO while a drug is still in early development to preserve their rights in specific names. USPTO approval, however, does not authorize use of a name. Before the drug is approved for use, its proprietary name must also be approved by the FDA. It is also worth noting that prescription drugs are given a higher level of scrutiny by all of the FDA’s divisions as compared to over-the-counter medications because of their greater potential for serious harm.
In many cases, the FDA’s rejection of a proposed proprietary name can substantially increase the time it takes to get a drug to market. To reduce this risk, it is important to understand the guidelines the FDA uses when evaluating proprietary names. In February 2010, the FDA published its Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names
The FDA’s approval process is handled through its Division of Medication Error Prevention and Analysis (DMEPA), in consultation with the Division of Drug Marketing, Advertising, and Communications (DDMAC). A manufacturer can submit up to two proprietary names, in order of preference, and the DMEPA and DDMAC will review the proposed proprietary names for similarities to other names currently in existence. The DMEPA completes over 500 proprietary name reviews annually and rejects roughly one-third of all proposed proprietary names.
For each proposed proprietary name, the DMEPA conducts its own tests to determine whether the name is confusingly similar to other proprietary or generic names. During its review, the DMEPA generates a list of proprietary and generic names that could be confused with the proposed proprietary name and does comparisons of the names in different forms and at various points in the healthcare system. In particular, the names are compared on the basis of their spelling, their pronunciation when spoken and their appearance when scripted, dispensed and administered. As part of this review, the DMEPA looks at the written appearance of the proposed proprietary name by examining different handwriting samples.
The DMEPA also considers whether the proposed proprietary name suggests a dosage form or route of administration or contains a USANC stem. For example, a pharmacist may mis-hear a name ending in “XL” as “SL,” the shorthand term for “sublingual,” meaning an under-the-tongue route of administration, or misinterpret TID as the abbreviation for ter in die, or three times a day. Similarly, names that contain numbers may be misinterpreted as indicating dosage (e.g., “Percocet 5,” which might be interpreted as suggesting five tablets per dose or 5 milligrams). Names that might produce these types of medical errors should be avoided.
In addition to the DMEPA review aimed at minimizing medical errors, the DDMAC reviews proposed proprietary names to prevent terms that are misleading. 21 C.F.R. § 201.10(c). Names that are overly fanciful such that they imply unique effectiveness or composition are likely to be rejected. Similarly, names that overstate product efficacy, minimize associated risks, broaden product indication or make unsubstantiated superiority claims should be avoided. In one famous example, DDMAC rejected the name REGAINE for a hair growth product as implying that the product would work for everyone. Ultimately, the product was branded as ROGAINE in the United States and REGAINE outside the United States.
Practice Tips Summary for Drug Naming
In particular, manufacturers should avoid drug names that (a) are confusingly similar to other generic or proprietary drug names; (b) could create confusion as to how the drug should be used or taken; (c) imply unique effectiveness; (d) could easily generate confusion with another drug if misspelled or when viewed in handwritten format; or (e) overstate efficacy, minimize associated risks, broaden intended use or make unsubstantiated superiority claims.
Medical Device Naming
The names of medical devices also are regulated in the United States by the FDA pursuant to the FD&C Act. Section 201 of the FD&C Act defines “device” broadly as including, among other things, any instrument, apparatus, implement, machine, or other similar or related article that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” Devices intended for human use are broken into three classes, each of which is subject to a different level of scrutiny by the FDA. All devices are also subject to “general controls” regulating, among other things, product adulteration, misbranding, device registration, premarket notification and good manufacturing practices.
While the generic and proprietary names of drugs undergo a formal evaluation before reaching the marketplace, there is no similar formal evaluation process for the FDA’s approval of medical device brand names. The reason drug names and device names receive different treatment is that many of the risks associated with look-alike and sound-alike drug names generally do not apply to medical devices. For drugs, the intended method of use typically is orally or intravenously, and the drugs themselves often are indistinguishable or unremarkable pills or liquids. Accordingly, patients and dispensers of drugs cannot always meaningfully distinguish Pill A from Pill B and have no reason to suspect a particular pill is the wrong one until an adverse event occurs. The consequences of mistakes also can be severe either alone or when the drug is combined with other medications a patient may be taking. In contrast, confusion between medical devices often is discovered prior to use of the device because medical devices have distinct appearances and are administered in distinct ways. For example, a doctor presented with an infusion pump while installing an implantable pacemaker should immediately recognize the incorrect device. Even for devices of the same type (i.e., different pacemakers with similar names), there is a lower risk of harm because the market of such devices is much smaller than the market of thousands of different drugs that could be confused.
Unlike the situation with drugs, the greatest risk of injury from medical devices typically is a result of the interaction of consumers with the device. For example, a device with unusually small buttons or a confusing interface is likely to cause the operator to misuse the device. The FDA tends to concentrate its limited resources on these issues rather than the name of the device because it can have a greater impact on preventing problems related to these types of issues. Nevertheless, the FDA can reject a device for having a misleading name, under its broad powers to prevent the sale of “misbranded” medical devices.
The FDA provides minimal guidance on the criteria it uses to evaluate whether a medical device name is misleading. That said, the same criteria guiding the FDA’s analysis of drug names provide useful guideposts for choosing medical device names. Following the practice tips below will prove helpful in selecting a medical device name that avoids FDA scrutiny.
Practice Tips Summary for Medical Device Naming
In particular, manufacturers should avoid device names that (a) are confusingly similar to other device names; (b) imply unique effectiveness; or (c) overstate device efficacy, minimize associated risks, broaden intended use or make unsubstantiated superiority claims.
Selecting the name for a drug or medical device is an expensive proposition. From a legal standpoint, however, the issues are fairly straightforward and known from the outset. By carefully considering the principles underlying the FDA’s role in protecting the public, manufacturers are more likely to select proprietary names that will move smoothly through the FDA’s regulatory review. This will avoid unnecessary delays and help bring the product to market more quickly.
Although every effort has been made to verify the accuracy of items in the INTA Bulletin, readers are urged to check independently on matters of specific concern or interest.
© 2011 International Trademark Association