Drug Naming In North America: It's Complicated
If you’re planning to develop a drug name for use in the U.S. and Canada, this article will help you understand the new regulations. And in my next post (Part 2), I’ll provide tips for helping you get your drug name approved.
Drug naming regulators in North America are asking biopharma companies for their help. They have been doggedly striving to wipe out potential medical errors linked to drug naming, and to reach that goal they are making some earthquake-force changes to name safety testing that’s sure to rock drug naming worldwide.
Forget the pilot programs and public forums. Been there, done that. U.S. and Canadian regulatory authorities have made it clear over the last year that the drug name safety testing game is changed. And this seismic transformation isn’t likely to ease up. If all goes as planned, 2015 will be remembered as the year where responsibility for drug name safety testing begins to shift from regulator to sponsor company.
The biggest driver for this change was orchestrated by Health Canada, who currently stands alone in legislating that sponsor companies submit a well-defined dossier of data supporting that their drug name appears safe in Canada. The new naming guidance in Canada takes effect on June 13.
And in the U.S. last December, CDER (the FDA’s Center for Drug Evaluation & Research) announced that it approved a stunning 74% of the proprietary names it reviewed over the previous eleven-month period. (Prior to that percentages hovered around 50% for a global brand name). Bravo to U.S. regulators who finally have something to rave about. CDER reasoned that their proposed “best-practices” guidance––which companies applied voluntarily––helped bump up the name acceptance rate to a record setting high. FDA will most likely enact new naming guidance this year too, raising the bar on name safety data requirements. (Although regulatory experts believe sponsor companies will not be required to submit proof in the U.S., as is required in Canada.)
The new regulations in Canada include an initial brand name review and LASA (Look-Alike/Sound-Alike) testing of new drug names to help avoid misleading associations or confusion with other products. These procedures are in line with traditional name safety testing methods. But for the first time ever, new drug names proposed for use in Canada will also need to be grilled under complex “medication-use process simulations” involving the prescribing, transcribing, selection, dispensing, and administration of the real-world dispensing environment.
My take: drug naming in North America just got more complicated. That’s because biopharma companies will be taking on more accountability, increased costs and extended time demands for name safety testing.
But if these new obstacles help boost the name approval rate, wouldn’t that make drug naming less complicated?
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