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We sat down with Alexis Caronis, Associate Director of Drug Safety at Fingerpaint Branding, to shed light on a critical but hidden process: guidelines for how new drug names and packaging are approved to ensure patient safety.

Drug Safety in Branding: Preventing Medication Errors

In the branding world, drug safety isn't just about monitoring drugs after launch (pharmacovigilance); it's about proactively applying regulatory guidance to proprietary names, logos, and packaging. The ultimate goal? To ensure new assets don't get confused with existing products, thus preventing potentially dangerous medication errors.

The Art of Regulatory Compliance

Bringing a new brand name (proprietary, trade, or invented name) to market means satisfying regional agencies like the FDA (U.S.), EMA (Europe), and Health Canada. This process means working within strict rules to create names that are distinct when spoken, written, or typed.

Assessing Name Similarity

All major agencies agree that a proposed name must not cause confusion. They assess similarity through two main methods:

  1. POCA (Phonetic and Orthographic Computer Analysis): An FDA-developed algorithm that scores the similarity of names.

  2. Look-Alike and Sound-Alike (LASA) Studies: Healthcare professionals review the name to see if it reminds them of any existing drugs.

The Global Benchmark: The 50% INN Rule

While agencies align on the basics, they differ on specifics. One of the more critical global rule comes from the EMA: we call it the 50% INN Rule.

This new guidance states that a proposed name cannot be more than 50% similar to any nonproprietary name (generic name). Since the FDA and Health Canada don't publish similar guidance, creative and marketing teams must generally adhere to the EMA's stricter 50% INN rule to achieve a truly global brand name.

Guidance vs. Guidelines: Know the Difference

The terminology used by regulators matters:

  • Guidance (FDA): These are "general considerations" that reflect the agency's current thinking. They are not legally enforceable rules, but best practices.

  • Guidelines (EMA/Health Canada): These outline the specific procedures that must be followed. Fail to follow them, and your name will be rejected.

The regulatory landscape is always changing, with agencies frequently updating their documents. This dynamic environment means drug safety experts like Alexis must stay vigilant, translating complex, evolving rules into safe, successful brands.

The next time you see a new drug name, remember the meticulous work behind the scenes to ensure its distinct identity is a matter of patient safety.

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Author: Brittany Scott Last Updated: October 20, 2025