FDA seeks to prevent the disastrous results that can arise from confusingly similar pharmaceutical trademarks.
Suppose a patient goes to the doctor for a cough that has bothered him for a week. After the examination, the doctor tells him to get plenty of rest and drink lots of fluids and scribbles a prescription for his local pharmacist to fill. The patient can’t read the prescription but figures: Who can? The pharmacist takes the prescription and gives the patient a bottle of little green pills. Funny, he thinks, the last time he had that cough he had little blue pills. Oh well, maybe it’s a generic version, or they changed the dye in the mix. It isn’t until the patient’s head swells to the size of a basketball and he’s rushed to the hospital that he learns that the pharmacist read the prescription as one brand name when the doctor meant another.
Sound scary? Such scenarios play out every day in the United States. By some estimates, tens of thousands of injuries and scores of deaths can be attributed annually to mix-ups between pharmaceutical brand names. With more than 3 billion prescriptions filled each year, it is virtually impossible to eliminate such errors completely. The Food and Drug Administration (FDA), however, is trying to minimize the potential for such mistakes.
Indeed, as part of that effort, on March 14, the FDA proposed rules to require bar codes within three years on all prescription drugs and certain over-the-counter drugs. See www.fda.gov/OHRMS/DOCKETS/98fr/03- 5205.pdf.
The FDA has also recently reorganized and assigned the role of trademark policeman to the Division of Medication Errors and Technical Services. Before that, the Office of Post- Marketing Drug Risk Assessment reviewed pharmaceutical trademarks, and before that there was the Labeling and Nomenclature Committee. These three offices have been working on a written guidance document describing the FDA’s policies and procedures for more than seven years. However, the release of such a document is not in sight, much to the continuing consternation of the pharmaceutical industry.
In the absence of such formal written guidance, industry is left with trying to piece together the process based on various unofficial articles written by FDA staffers, word-of-mouth experience and FDA enforcement actions. The result is sometimes an unclear or inaccurate picture of the FDA’s decision-making process.
The FDA’s review of a proposed new brand name can be divided into three main areas of concern: Is the name misleading? Could the name contribute to prescription errors? Could the name be confused with the name of another drug?
The FDA does not like brand names that imply the drug has some unique or exaggerated effectiveness. Perhaps the most well-known example is Rogaine, which is marketed in much of the rest of the world as Regaine. The FDA, however, felt that Regaine too strongly suggested that anyone who used the product would regain his hair, when in fact the product is not effective for everyone.
Pharmaceutical brand names should also avoid references to inactive ingredients that might suggest they have an effect on how the drug works. Also frowned upon are names that include superlatives such as pro, max, ultra or super, particularly since such implied superiority claims may soon become outdated.
Other sources of errors
Prescription errors occur when the right drug is dispensed, but in the wrong strength, route of administration or regimen. It can result in particular from the use of suffixes or prefixes that consist of numbers or abbreviations as part of the trademark, which are then misinterpreted by pharmacists.
For example, the trademark Percocet 5 was read to signify five tablets per dose. The Roman numeral IV could be misread to mean “intravenous.” Similarly, BID (short for bis in die in Latin) is a common medical abbreviation meaning twice daily, and thus should be avoided as part of a trademark. Care should also be taken to consider how a trademark could be misheard and not just misread. One example is XL, which could be misheard as SL, which would mean sub-lingual to a pharmacist.
This concern is lessened when the drug is sold over the counter and not by prescription. By removing the pharmacist from the equation, there is less chance that the abbreviation or number will be read to have a specific medical meaning. Tagamet HB (for heartburn) and Pepcid AC (for acid control) are two familiar examples. However, selling a drug over the counter does not give a manufacturer carte blanche to append potentially dangerous prefixes or suffixes to its mark, since even a consumer could misinterpret such marks with potentially harmful consequences. For example, imagine the result if Smith’s Aspirin 20 were misinterpreted by a consumer as meaning to take 20 tablets at a time.
Confusion with other drug names seems to cause the most harm and receive the most attention in the press. Despite the good intentions of the pharmaceutical industry and the FDA, mistakes are made every day in dispensing the wrong medication to patients as a result of such confusion. Fortunately, not every mistake results in serious harm, but the risks are real and sometimes disastrous consequences do occur.
The FDA’s concerns
The FDA compares a proposed new drug trademark with the trademarks and generic names of drugs that have already been approved for marketing. The agency will consider similarities in the names as spoken, as printed and, perhaps most controversially, as they would likely be written by a physician. The “handwriting analysis” is undertaken by scores of FDA volunteers who participate in studies to try to determine how a physician would write a name and how pharmacists would read it. Because of physicians’ notoriously bad handwriting that often trails off into an illegible scrawl, the FDA tends to place the most importance on the beginning letters of the trademarks—the more similar they are, the greater the chance of confusion.
The FDA prefers that drug trademarks not incorporate the generic stem of any drug. While this used to be a fairly common practice, there is concern that use of the stem as part of the mark will limit the ability of variations of the drug to be given appropriate generic names. In addition, trademark owners should be concerned that consumers will come to associate their brand names as essentially equivalent to the generic name, which, for the short term, may be good for marketing but in the long run would destroy the trademark.
In a departure from what is familiar in other industries, drug trademarks from a single manufacturer should not incorporate a common element, which could increase confusion. For example, the ubiquitous “Mc” formative used by McDonalds for many of its products helps to create a strong “family” of “Mc” marks, fortifying McDonalds’ rights in the “Mc” formative. Such an approach for pharmaceuticals, however, is fraught with potential problems, as use of a common element would only increase the chances for tragic mistakes.
The FDA review process
The earliest the FDA will review a proposed drug trademark is at the end of the Phase II human clinical trials—tests for drugs that are undergoing further study for safety and efficacy on a relatively large number of subjects. Years ago, the FDA had accepted requests for review as early as the time of the investigational new drug application, the part of the process seeking authorization for clinical trials to begin. However, as many drugs do not move forward in the development process, there was some concern that the FDA was devoting resources to reviewing drug trademarks that soon became abandoned.
Waiting until the end of Phase II clinical trials helps to ensure that the FDA is not wasting its time. The industry complains, however, that the later review increases the uncertainty as to whether a preferred name will be accepted and increases the cost of any future name change.
A manufacturer may submit two names to the FDA for review at the same time, in order of preference. If the first name is accepted, the agency claims it will not bother to review the second, though there are some who suspect the FDA will look at both and choose the one it prefers.
Proposed indications, labeling
Manufacturers should also submit the proposed indications for use and other proposed labeling as part of the request for review. If any studies have been done by the manufacturer to “validate” that the name will not cause confusion, those should also be submitted. Indeed, there is some talk that such studies may eventually become mandatory.
If the name is accepted, it will receive a “tentative” approval. That is because the FDA still does not know if the drug itself will be approved for marketing. Approximately 90 days before final approval of the drug is expected, the FDA will give the name one last review to make certain it would not cause any problems with names that were given final approval since the initial “tentative” approval. Unfortunately, the FDA does not publish a list of “tentatively” approved drug trademarks. Thus, there is no practical way of knowing for certain what is “in the pipeline” at the FDA.
Perhaps even more surprising, the FDA does not operate on a “first in time, first in line” rule. Rather, the first company to have its drug approved by the FDA, even if it submitted its request for a trademark review after an earlier applicant, is the “winner” of the mark in the FDA’s eyes.
Even after final approval, if the trademark later proves to be problematic in the marketplace, the FDA has the authority to require a change after product launch, which of course can be an expensive undertaking.
The role of the PTO
The FDA is not the only government agency with authority over drug trademarks. The U.S. Patent and Trademark Office (PTO) is the agency in charge of “registering” trademarks of all kinds, not just for pharmaceuticals. While registration is not required, it provides many benefits, and is certainly advisable for any company that intends to invest any substantial sum of money in a product, as is the case with most pharmaceuticals.
The registration process can begin very early in the product life cycle. Indeed, it is possible to file an application at the PTO based on a bona fide intent to use the mark. Filing an application establishes the applicant’s priority date with the PTO. Thus, unlike the FDA, the PTO does operate on a first in time, first in line rule, and all trademark applications are a matter of public record.
Once an intent-to-use trademark application is filed, assuming all goes well, the applicant will receive in about a year or so a notice of allowance. This gives the applicant three years to begin use of the mark in commerce and obtain a trademark registration. The legislative history of the Trademark Act makes clear that use of a mark in pharmaceutical clinical trials is sufficient to entitle the applicant to a registration. Accordingly, a trademark registration can be issued as early as the beginning of Phase I clinical trials (i.e., initial testing on humans to evaluate the drug’s pharmokinetic and pharmacological effects). This is obviously earlier than the request for review can even be submitted to the FDA at the end of the Phase II trials.
However, merely because the PTO has found the mark to be acceptable does not bind the FDA, as the FDA analyzes a mark from a public safety perspective, which is not the PTO’s field of expertise.
Everyone involved in the pharmaceutical name game is interested in public safety. No reputable drug company adopts a mark knowing that it entails significant risk. Unfortunately, experience in using a name does not always match expectations, and unforeseen confusion can occur. Both the FDA and industry continue to struggle with this issue, seeking to strike the right balance between manufacturers’ trademark rights and desire for certainty on the one hand, and protection of public safety without overly burdening industry on the other.
Keith Barritt is Principal in the Washington, DC office of Fish & Richardson. He specializes in trademark and FDA law and has spoken on several occasions on the interplay between these two fields. He can be reached at email@example.com.
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