for the healthcare and pharmaceutical industry
Brand Name Submittal Strategies
Brands stay relevant by differentiating themselves in a world that changes continuously. This is achieved by remaining true to their essence, which is why well-chosen brand names are invaluable. Since 1984 Globrands articulates the brand’s identity in a way that is effective, appealing, future-ready, and unique.
Maximizing a successful outcome
The most significant steps to 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 minimize the risk of rejection and accelerate the success of the process is to understand how the FDA evaluates names and what factors they consider. Look at the 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 the actives as well as the excipients, and make a first-level cut at what should move forward in the process.
The next step is to test the name candidates for similarity to other brand names on the market and consider the proposed names 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? Always 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.
It is important to test candidate names through interviews, focus groups or online testing to end-users and professionals.
If the new drug is expected to be a blockbuster, be sure to invest in testing the name with relevant constituencies before you even walk through the door at the FDA. This may help speed up the FDA approval and will help to avoid potential rebranding situations later on in the process.
How Many Brand Names Should You Submit for FDA Approval?
We are often asked whether to submit one or two names for FDA for approval.
We usually recommend to register a number of names and then decide which 2 or 3 will be moved forward in the FDA process, to avoid that the FDA has approved your name only to learn that someone else was is already using the same name or a confusingly similar one for pharmaceuticals or in a related area that doesn’t require regulatory approval.
Name Submission Background
It's no secret, manufacturers of pharmaceutical and biologic products are faced with enormous challenges in bringing new products to market.
One of the hurdles to overcome is gaining approval of aproprietary/brand name for the new product by regulatory authorities in territories around the world including the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, Ministry of Health Labour & Welfare (Japan) and for instance the Indian Health Authority CDSCO.
Name review and approval
Though the FDA has published a document on how it reviews names.
Reports vary as to precise approval rates, but for product marketing teams it is reasonable to consider approval of a preferred brand name for a new product, effectively a coin toss. About 35-40 percent of all brand names submitted to the FDA are rejected. Similar numbers are experienced in Europe as well.
The EMA and FDA provide guidelines for the submittal of a brand name(s) for approval. Both agencies will accept more than a single name for evaluation.
In the US, the FDA will accept up to two brand names for review (a primary and back-up); however, it will only test one name at a time. They will test the primary name until they may find a reason to reject it. Then (after notifying the sponsor) will immediately begin testing the back-up name (if one was submitted).
In Europe, the EMA will take up to four brand name candidates and will complete an analysis of all four names and provide feedback on the acceptability of each name to the sponsor.
With the FDA submittal being the initial target market for many products, sponsors often start their brand name submittals with the FDA and work to the rest of the world from there. Sponsors are now contemplating if submitting a single primary name is the right choice, or submitting a primary and back-up as allowed is a more resourceful tactic.
Why only submit one name? There are companies that feel that if they provide more than one name to the FDA, it increases the likelihood that the primary name will be rejected and the back-up then approved. The FDA's stated position is that they do not evaluate a back-up name until the 1st choice is rejected.
In addition to the review of the clinical data of products themselves, health authorities are responsible for reviewing proposed brand names for new molecules, biologics and medical devices to assure they are within the safety and marketing guidelines of that agency.