The FDA way

Ira Levy of Goodwin Procter discusses the FDA regulation for drug names and how companies can reduce their chances of rejection.

What is the US Food and Drug Administration mission when it comes to pharmaceutical brand names? I think the fundamental mission of the Food and Drug Administration (FDA) is to reduce the risk of error in all its forms, including medication errors and the misbranding of drugs, which have caused a significant number of deaths in the US. The primary function of the FDA naming process, in my opinion, is to minimise or eliminate (to the extent possible) the risk of medication errors that result from the branding or naming of a pharmaceutical product. Its secondary function is to make sure that approved names don’t communicate anything false or misleading to consumers who may be taking the drug. This is from both a safety perspective, as well as an expectation perspective on the part of the consumer.

What steps can be taken from a legal prospective to maximise the likelihood of a successful outcome from the FDA? We tend to look at two things: first, it’s a combination of a business and legal perspective because you’re giving the legal guidance to the situation, and second, it’s marketing and branding working hand-in-glove with legal. The most significant steps you can take involve testing and examining the name before applying for trademark protection or submitting the name to the FDA or any global regulatory authority. One way to legally minimise the risk of rejection and accelerate the success of the process is to really understand how the FDA evaluates names and what factors they consider. You need to look at your drug candidate and the FDA process and be aware of the other products and drug treatments available, understand the generic nature of the ingredients that are part of your actives as well as your excipients, and be able to make a first level cut at what should move forward in the process. The next step is to begin testing your name candidates internally at the pharmaceutical company and through external counsel and consultants who are able to run the names through tests similar to those the FDA uses.

While not a guarantee of success, using pre-screens similar to those the FDA recently identified in their draft guidance will help you avoid the issues that are immediate red flags. The straightforward tests include researching whether the name is similar to something else on the market and whether it uses medical or coined abbreviations. You can also look at the adoption of medical names. The FDA is better at giving advice about what you shouldn’t do than it is at telling you what you should do. Step one is don’t do the things it suggests you don’t do. It almost sounds obvious, but a lot of the time, marketing will fall in love with a name and it is up to legal to push back and say, “we won’t be able to bring the product to market with the name you’ve selected and any push back will delay the approval process”. Legally, once you get past the pre-screens, you need to think of the validation tests that the FDA uses. For example, you need to consider your proposed name from the oral or spoken perspective. Is it going to sound too much like something else when called out by a medical professional, patient or even pharmacist? You always have to consider whether a doctor’s written prescription is going to look too similar to something else.

Studies have shown that when a physician writes a prescription the first couple letters of the drug name are clearer than the last couple. So, if you have two drugs that begin with the same letter string, there may be an increased likelihood for confusion at the point of dispensing, and an increased risk of a medical mistake. You could also bring the candidate names to consumers through focus groups, mall studies or online testing through questionnaires and surveys. Informal surveys of doctors and pharmacists are also effective. If you are expecting the drug to be a significant player in the marketplace, you should make an early investment and put some dollars into testing the name with relevant constituencies before you even walk through the door at the FDA. This may help speed up your FDA approval and will help you avoid potential rebranding situations later on in the process. Making the investment may also prove advantageous for you if the FDA later rejects the name. Which comes first when registering a drug trademark—FDA approval or a US Patent and Trademark Office filing?

What’s the best strategy? There is no legal requirement one way or the other. In fact, there is no requirement that you even seek a registration at the US Patent and Trademark Office (USPTO). That said, from the protection perspective, my view is that it is usually best to apply to register a number of names on an intent-to-use basis, presuming that you have a bona-fide intent to use, and then decide which two you will move forward in the FDA screening process. You don’t want to end up getting a mark approved by the FDA that you can’t protect at the USPTO, and by the filing your intenttouse application with the USPTO you are putting your stake in the ground. It would be very unfortunate to find that the FDA had approved your name only to learn that someone else was (or is) using the name, or a confusingly similar name, in a related area that doesn’t require regulatory approval, thereby blocking your ability to trademark the name.

What tools can be used to prevent consumer confusion or the likelihood of trademark infringement? Trademark infringement disputes over proprietary drug names are rare. For the most part, the steps one takes to avoid confusion for the purposes of FDA approval will generally, but not always, minimise the risk of brand confusion and related actions. Where you find more risk is when you have a proprietary drug name that may perhaps be confusingly similar or a dilutive of a name of a product in a related field, and likely one that does not require regulatory approval. The tools that are generally used to clear a mark for use and registration in the pharmaceutical space are the same clearance tools that we use for any other trademark registration process. These involve knock-out and comprehensive searches, investigation and follow up of common law uses, domain registrations and the like, and purchase and acquisition. In other words, where you are talking about a large revenue product, you may buy some of the names that are already out there and which pose either a risk of consumer confusion or at least raise the potential for a challenge, which is something you don’t want to deal with during a product launch. In some instances, you may end up purchasing another business, in others just the name. What you are effectively doing is clearing the landscape so you won’t even see challenges when you’re introducing the name. I should also note that in this industry, people know each other and you can often address concerns through a phone call from in-house counsel to in-house counsel. Unless there is a compelling legal or commercial reason, pharmaceutical companies don’t usually want to spend their money challenging each other over trademark issues (patent and advertising issues, among other things, are a different story). There are many instances where potential conflicts can be resolved informally and concerns about confusion risk can be addressed.

When you move to over-the-counter (OTC) drugs, there are more significant issues to contend with because the risk of consumer confusion is greater as a result of the way that OTC drugs are presented to consumers through advertising, packaging and point of sale merchandising. There are number of things that are done to distinguish one brand from the next, including the corebranding elements, which include the name itself and package presentation in terms of size, colour and layout. All of the above, taken in context, can diminish the risk of consumer confusion.