The United States Food and Drug Administration (FDA) recently released a long-awaited draft guidance document for the development and assessment of proprietary drug names for prescription and non-prescription products. Regulatory decisions can sometimes impact the pharmaceutical industry in unpredictable ways, so this guidance is a welcome addition. But will these guidelines drive the industry toward greater consistency and predictability in proprietary name reviews?
Here are four key takeaways from InterbrandHealth’s analysis of the draft:
1. The FDA is instituting a number of criteria that can be objectively measured
One of the key challenges in naming research is that it produces few black and white results; we’re often forced to manage many shades of grey. Within the draft guidance document, the FDA aims to present more tangible metrics—pre-screening criteria, checklists, specific categories for its POCA tool (Phonetic and Orthographic Computer Analysis)—that should, in theory, result in greater standardization in the approach to name testing and therefore greater predictability in outcomes. The FDA also has provided its latest thinking on a number of topics that have created anxiety for our industry in the past, including brand modifiers and “dual proprietary names.” While some of these topics will still be assessed on a case-by-case basis, the draft guidance offers hope of greater consistency.
2. POCA plays a starring role in the guidance
When first released, the FDA’s POCA algorithm was viewed as one of many inputs to a name safety assessment. With the new draft guidance, the FDA is placing greater emphasis on the results of a POCA search than we have experienced to date. Now, the FDA has officially grouped POCA scores into three categories and is using these categories as the basis for a final safety evaluation. This is a bit of a departure for the FDA that certainly warrants monitoring.
The draft guidance document places greater emphasis on name similarity versus other contributing factors to medication errors than ever before. Many of the industry’s more practical arguments for why a proprietary name candidate will not be confused with an existing marketed drug in the real world—including differences in how products are actually prescribed, dispensed and administered—may no longer be persuasive. This is particularly true of names that score higher than 70 on POCA with an existing drug name. Despite differences in product characteristics, the FDA states that these highly similar names are at risk for confusion. At InterbrandHealth, we have found POCA to be a useful tool in prioritizing potential safety conflict. However, our experience also suggests that the results can range from inconsistent to confounding. So, it will be very interesting to see if POCA can, in fact, serve as a successful filtering tool.
3. The FDA is looking for more rigorous prescription simulation studies
The best practices summarized in the draft guidance for prescription simulation studies are similar to the FDA’s 2008 PDUFA Pilot Concept Paper. The FDA is requesting that at least 20 scenarios be included in a prescription simulation study, including marketed products. While this is feasible in a market research study, it will increase survey complexity. Applicants may need to rethink existing approaches and be prepared to invest more time and money to complete this “recommended” market research.
As noted earlier, over-the-counter (OTC) products fall under the draft guidance document, which implies that these sponsors may need to conduct more in-depth testing, including more prescription simulations.
4. There is no mention of Failure Mode and Effects Analysis (FMEA)
Our final observation addresses not only what’s in the draft but also what’s missing. In the 2008 PDUFA Pilot Concept Paper, the FDA alluded to the importance of FMEA in a sponsor’s name safety assessment. In a significant departure from this earlier stance, FMEA is now completely omitted from the draft guidance document. While sponsors are not being asked to complete this analysis, we are curious to see whether the FDA will continue to conduct FMEA as part of its safety review for proprietary name candidates. Currently, it appears that the FDA is asking the industry to generate initial hypotheses for a review through its requested methods and then this data will be fed into the internal evaluation. InterbrandHealth envisions this could limit the voice of a sponsor in its attempt to present a rationale for proprietary name selection beyond the outcomes of the prescription simulation studies and POCA results.
In summary, the draft guidance offers greater clarity and the possibility of increased predictability, but it is too soon to know if the endpoints summarized in the document will “guarantee” an FDA approval of a proprietary name candidate. The removal of FMEA, while reducing subjectivity, is particularly surprising. However, it appears that through the launch of this guidance, the FDA is looking to the industry to help shape and standardize the process with a goal of creating greater certainty in outcomes, which is a positive step.
InterbrandHealth is currently submitting comments to the FDA regarding the draft guidance document, and we look forward to uncovering its implications as the guidance comes to life through our work.
John Breen is the Executive Director of Analytics for InterbrandHealth. Lillian Smith is an Analyst for InterbrandHealth.
For more information about the drug naming process or the FDA guidance document, connect with InterbrandHealth here.