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US FDA’s ‘Active Moiety’ Approach On NCE Exclusivity Codified Under Drug Pricing Legislation

 
• By Sue Sutter

Measure clarifies the meaning of new chemical entity by replacing the term ‘active ingredient,’ which encompasses esters and salts, with ‘active moiety’ as defined by the FDA; legal experts are skeptical the measure will generate cost savings and say it gives the agency wide latitude to make future changes in eligibility for 5-year exclusivity.

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Legislative language on 'successor regulations' provides an opening to future changes in the FDA's definition of 'active moiety.'

A bill codifying the US Food and Drug Administration’s current approach to determining new chemical entity exclusivity appears to give the agency leeway to make future changes in how it defines potentially eligible drug products, legal experts said.

The Ensuring Innovation Act (S. 415) was signed by President Joe Biden on 23 April after passing the Senate...

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