4 September 2014 Susan M. Proulx, President, Med-ERRS
|How will these current trademark development
and selection process and their trademark’s chance of approval?
The pharmaceutical industry is all too familiar with how exceedingly challenging it can be to achieve a viable trademark that is accepted by the health authorities, especially if obtaining a global mark is the end goal. Over the past few years, health authorities in several countries have been developing their proprietary name guidances. In the last six months alone, both Health Canada and the FDA released guidances pertaining to proprietary name development – Health Canada’s proprietary name guidance was finalized and FDA released its first-ever initial draft guidance on the topic of name selection and development. Industry is now curious to learn how these guidances will affect their current trademark development and selection process and their trademark’s chance of approval.
Let’s start with the FDA’s recently-released trademark guidance. Back in May of this year, the FDA released a highly anticipated draft guidance for industry titled “Best Practices for Developing Proprietary Names for Drugs.” This guidance is a joint Guidance with CDER and CBER and applies both to prescription (drugs and biologics) and over the counter products. It is important to note also that a guidance is the FDA’s current thinking but does not bind the sponsor or the FDA. The purpose of the guidance is to help sponsors of drugs and biologic product applications develop proprietary names that do not cause or contribute to medication errors or the misbranding of the drug.
The guidance details four main steps to help eliminate unsuitable trademarks and narrow down a safe name for the company’s product. The four-step process involves:
The most notable inclusions in the guidance at this point fall under step 4 and consist of a search for and categorization of similar names using Phonetic and Orthographic Computer Analysis (POCA) and full-scale simulation studies for each proposed mark.
- Prescreening Proprietary Name Candidates
- Considering Other Attributes That Might be Misleading or Error Prone
- Misbranding Review
- Methods for Evaluating Look-alike, Sound-alike (LASA) Safety of Proposed Proprietary Names
Some of Med-ERRS concerns with the FDA draft guidance include:
- The use of POCA to such a great extent considering the limited value it has provided in the past
- Names with only a strong look-alike or sound-alike issue being overlooked because they do not receive a high enough combined score to be considered significant
- Impact of the imminent IT challenges with downloading POCA system
- Having both Rx and OTC products in the same guidance
- The true value of the recommended simulation testing versus its ROI (return on investment) for time and cost
Some additional, unanswered questions pertaining to the guidance that Med-ERRS would still like clarity on are:
- What is the benefit to following the draft trademark guidance?
- Will the new guidance uncover more issues with names, in comparison to industry’s current processes and procedures?
- Given the guidance’s similarity to the 2008 PDUFA IV Pilot Project, will this guidance prove to be useful?
- How much of the work outlined in the guidance should be done before submitting to the FDA?
Health Canada preceded FDA in releasing a proprietary name guidance. Their guidance is titled “Review of Drug Brand Names” and was finalized in March 2014, however it has yet to be formally posted. Sponsors will be expected to follow the guidance starting after a one-year “phase-in” after its posting. Health Canada’s guidance is similar to the FDA guidance in that it calls for a highly involved, time- and resource-intensive process. However, at this point, Health Canada’s guidance is more specific with regard to the requirements necessary for a satisfactory brand name assessment and how sponsors should utilize and incorporate the data obtained from evaluations that are conducted. In addition, Health Canada does not plan to conduct a parallel assessment of the proposed names after the sponsors have already done so (the FDA still plans to conduct its own internal review on submitted trademarks).
Health Canada’s guidance requires sponsors to complete the following:
- Initial Brand Name Review – Screening of proposed names according to general safety criteria
- Look-alike, Sound-alike Brand Name Assessment
- Search - Search proposed names against Canadian drug databases, identify names with high similarity scores and search published literature for error reports
- Simulate - Develop use process map(s) for proposed names and conduct medication-use process simulations
- Synthesize – Conduct Failure Mode and Effects Analysis on names that are identified as confusing and develop report(s) to submit to Health Canada for final chosen name
As you can see, there are notable similarities in both Health Canada and FDA’s methods. Hopefully there will be ways in which sponsors can avoid duplicating efforts when looking to launch products in both the US and Canada (such as reusing already developed process maps).
At this stage, there are more questions than answers when it comes to obtaining trademark approvals in the US and Canada. The picture in Canada is a bit more clear and definitive whereas the FDA process is more uncertain and slightly unclear at the moment.
As far as obtaining a global trademark goes, in general it is becoming increasingly more difficult to get a universal name with the increase in rejections and increased scrutiny by regulatory authorities. A global trademark can decrease the risk of a wrong drug being dispensed to a patient when traveling, so sponsors would prefer this, but this is becoming more challenging to achieve.
One of the primary questions that remains is: if testing is done according to the guidance, then will we actually see an increase in approvals? Along the same lines, should we also be expecting to develop and/or test more names and if so, how do sponsors budget for this and still anticipate an ROI in a particular country? If a sponsor aims to launch a product in many different countries, yet only two of them require they follow a stringent set of recommendations, should the sponsor then conduct this same type of testing in every country it is looking to launch in?
In an effort to summarize the complex issues, below are some issues and items that sponsors may want to consider when planning their trademark development and approval strategies. Should sponsors:
- Start name creation and initial trademark testing earlier?
- Create and maintain a name bank (names with preliminary name clearance)?
- Develop names that would not necessarily be attached to a particular product?
- Conduct trademark safety testing in countries without current requirements?
- Define a filing strategy of where to file first (a potential time and cost saving strategy)?
- Consider countries that historically have the most rejections and/or the largest market (US?)?
- Consider countries with the most comprehensive evaluation process (Canada, now US)?
- Consider countries allowing the most name approvals per product (N =2) (EMA)?
Although there are still many unanswered questions, Med-ERRS genuinely hopes that the forthcoming changes and increased regulations will ultimately lead to safer marks, fewer medication errors and an increase in patient safety in the years ahead.
Stay tuned and sign up for Med-ERRS quarterly newsletters to understand how obtaining a global trademark will be further impacted by the EMA’s newly finalized “invented names” guidance (version 6) which will be coming into effect January 1, 2015.
Susan M. Proulx, PharmD
200 Lakeside Drive, Suite 200
Horsham, PA 19044
Susan M. Proulx, PharmD has held the position of President of Med-ERRS since 2000, after working as vice president of operations for ISMP, the parent company of Med-ERRS, for five years. She earned both a BS in Pharmacy and PharmD degrees from Northeastern University in Boston, MA and completed an ASHP Residency at the Veterans Administration Medical Center in Philadelphia, PA. Her previous professional experience includes both community and hospital pharmacy practice with eight years’ affiliation with the Medical College of Pennsylvania and its hospital in clinical and program director positions. Prior to joining ISMP in 1995, Dr. Proulx was a pharmaceutical consultant, as well as director of business development for ADIS International. She is frequently invited as a lecturer for state, national, and international healthcare organizations on medication safety issues.