5 Tactics To Easier Drug Name Approval


If you’ve read my previous post (Part I––see blog, "Drug Naming In North America: It's Complicated"), you have a better understanding of how new naming regulations in North America will shake out. This post (Part 2) lays out several tactics to help your drug name pass regulatory muster given all the cosmic shifting in the drug-naming world.

To the rest of the biopharma industry, percentages matter: stock price growth, market shares, survival rates, etc. But to executives charged with drug naming, one particular percentage has for the last two decades mattered most: the percentage of drug names approved by regulatory authorities. Regrettably, the percentage comes in at around 50% for a global brand name. So when CDER (the U.S. FDA’s Center for Drug Evaluation & Research) announced last December that it approved a whopping 74% of the proprietary names it reviewed over the previous eleven-month period, it was, well, a bombshell.

That’s because during that same period, biopharma executives were roiling over proposed regulatory guidances that further aimed at putting the kibosh on drug naming medical errors in the U.S. and Canada. The new guidances appear to add more cost and more time to the process without future-proofing proprietary names with greater assurance of their approval.

Weightier research and analysis––without guarantees––look to be the new drug naming calculus in North America. But there’s good news too: it may bump up the name approval rate (as CDER reported). So here are 5 take-charge tactics to help you be more successful with this new math:

  1. Start naming earlier. Getting ahead of the game offers marketing and legal availability advantages (see an earlier post––Drug Naming Wish List 2015). Depending on your launch date projections, beginning the brand naming process in Phase II is a good target to shoot for.

  2. Budget more. Part 1 of this series (see blog, Drug Naming In North America: It's Complicated) argued that the burden of proving brand name safety is being delegated to sponsor companies. As more responsibility for testing names under many complex scenarios and data analysis increases, expect drug-naming costs to escalate.

  3. Determine your strategy. This may be obvious, but determining your branding priorities can help you with key naming decisions. One such decision a client of mine made was to exclude Canada from their initial launch naming plans, creating savings in cost and time. (They plan to add Canada at a later date.)

  4. Get creative. You'll need more good names to work with under the new rules. So plan to carve out a solid creative strategy with your professional firm that will boost both the distinctiveness and the quality of drug naming. Bonus tip: don’t settle for lists of randomly derived names or name variants.

  5. Submit a data “package” to regulatory authorities. Building a persuasive and data-driven drug name safety story improves your chances for name approval, not only for Canada (where it’s required starting June 13th), but for the U.S. too.

There is no magic bullet for drug name approval. But no matter what, carry out the standard name evaluations professionally––legal availability, linguistic suitability, and name safety testing––and follow current regulatory best-practices principles. At least you’ll build up your confidence, if not your name acceptance too.

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