The U.S. Food and Drug Administration (“FDA”) recently issued Draft Guidance to the Industry, titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products,” that proposes a change in its longstanding policy concerning 5-year new chemical entity (“NCE”) exclusivity for fixed-combination drug products.  For many years, FDA’s interpretation of the word “drug” in certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the term “new chemical entity” meant “drug product.”  Now, FDA proposes altering its interpretation of “drug” and “new chemical entity” to mean “drug substance” or “active ingredient.”

FDA’s new interpretation of these terms would result in a determination of 5-year NCE exclusivity for each active ingredient (or active moiety) in a drug product instead of the drug product as a whole.  This proposed change deviates from FDA’s longstanding interpretation whereby fixed-combination drug products were ineligible for 5-year NCE exclusivity if the product contained any active ingredient not considered a new chemical entity.

In 2013, several petitioners asked FDA to revise its interpretation of the 5-year NCE exclusivity provisions.  FDA concluded that the new interpretation urged by the petitioners would be beneficial to public health in light of the increasing importance of fixed-combination products to treat serious diseases and conditions.  FDA noted its interpretation change would further incentivize the development of certain fixed-combination products.

Because the proposed interpretation represents a change in FDA’s existing interpretation that is of “more than a minor nature,” FDA issued the Draft Guidance document to solicit public comment and does not intend to apply the revised interpretation until the Guidance is finalized.  Comments can be submitted here until April 25, 2014.  When finalized, FDA intends to apply the new interpretation prospectively so it will not apply to fixed-combination products already marketed.

ANDA-filing decisions for fixed-dose combination products should begin to consider the FDA’s revised interpretation, but absent a change in course before it is finalized, it should not impact fixed-combination products already marketed.