Amends the Federal Food, Drug, and Cosmetic Act for new chemicals

Apr 23, 2021

Summary

Changes the definition of a new drug from 'active ingredient' to 'active moiety' to clarify which drugs get special protection from competition.

What problem does this solve?

The old rule for what makes a drug 'new' was unclear, letting companies get extra protection for small changes to old drugs. This law uses a more specific term, 'active moiety,' to ensure only truly new drugs get this protection, which can help generics come to market faster.

What does this law do?

Redefines 'New Chemical' for drug exclusivity

Replaces the term 'active ingredient' with 'active moiety' to define what qualifies as a new drug eligible for market protection from generic competition.

Requires advisory committee review

Mandates the FDA refer drugs with a new active moiety to an advisory committee for review before approval, or explain in writing why it did not.

Applies new definition to special drug programs

Ensures the 'active moiety' definition is used consistently across programs for rare pediatric diseases and other special cases.

Who does this affect?

Pharmaceutical companies
Food and Drug Administration (FDA)

What is the real world impact?

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Promotes fair drug competition

Clarifies rules for drug exclusivity to prevent companies from getting extra market protection for minor changes to existing drugs. This helps generic versions become available sooner.

When does this start?

This law becomes effective on April 23, 2021.