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September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch-Waxman strove to offer consumers the benefits of “rapid availability of lower-priced generic versions of innovator drugs” while preserving a meaningful period of market exclusivity for innovators to recoup their costs. In the process, however, Hatch-Waxman established conditions that fundamentally influenced proprietary naming decisions, in particular, incentivizing the introduction of new products that reuse marketed proprietary names to capitalize on brand popularity. These closely named products are commonly known as brand-name extensions (BNEs). Hatch-Waxman’s milestone anniversary, coupled with the recent release of FDA’s Draft Guidance on Best Practices in Developing Proprietary Names for Drugs, drives us to ask: When it comes to innovative drug products, what’s in a name?
This article explores the numerous and complex drug and biologic naming considerations the implications for both consumer safety and products’ market viability.
This article explores the numerous and complex drug and biologic naming considerations the implications for both consumer safety and products’ market viability.