Here are 7 steps to consider when constructing brand names that will pass FDA scrutiny.
What’s in a name? For Shakespeare’s Juliet of the Capulet clan, “Montague,” the family name of her beloved Romeo, rendered him off-limits in the eyes of her handlers and ultimately led to the youngsters’ deaths. For patients filling prescriptions at the pharmacy, a wrong or confusing name can also have life or death implications.
A recent Thompson Reuters report, “Pharmaceutical Trademarks: How to Survive the Name Game/New Challenges and Opportunities for Pharmaceutical Companies,” details how the FDA and pharma companies are striving to reduce errors based on trade name confusion.
With the PDUFA IV Pilot Program, the FDA will evaluate a proposed 7-step process for drug name review against its standard practices. Although results will not be disclosed until 2012 or 2013, biopharma companies can make use in the meantime of the proposed protocol to help streamline their efforts.
The pilot program uses these 7 steps:
1. Preliminary screening flags names using common abbreviations, such as BID or TID, or abbreviations that could cause medical errors
2. USAN stem search ensures that the generic is not part of the trade name
3. Comparison with existing trade names, based on spelling/orthographic style and phonetics
4. Other computational methods that reveal similarities to current drug brand names
5. A review of medication error data for the proposed name—in this country or elsewhere
6. Name simulation studies use focus groups to test spoken or written interpretation of the brand name and uncover any potential points of confusion
7. Using failure mode and effects analysis to help brainstorm on where or when a name-based error could arise, and how to overcome these types of errors
One gift that the FDA has given to biopharma companies for screening trade names is software. The source code for the Phonetic Orthographic Computer Analysis (POCA) program (which the FDA uses to suss out viable drug names) has been available for public use since 2009. Request the software for your company at [email protected].
According to Thompson Reuters, drug names are often developed at the end of Phase I clinical trials. From a few hundred names, 5 to 10 are typically submitted to the United States Patent and Trademark Office (USPTO) 1 to 2 years before the anticipated FDA filing date for the drug.
One name and an alternate are submitted to the regulatory agency.
It is critical to develop appropriate names from the start. Consider incorporating some of the FDA’s proposed strategies into your process, whether this means debating earlier over phonetics and generic similarities, or gathering feedback from an assembly of doctors and pharmacy workers who will need to communicate clearly on your brand name.
This preliminary work will help your team avoid a ripple effect on your later marketing materials if the FDA rejects your preferred product name.
