BGOV Bill Summary: S. 415, New Drug Exclusivity

The criteria for a drug to receive exclusivity as a new chemical entity would be modified by S. 415.

The bill would codify the Food and Drug Administration’s approach to granting five years of exclusivity to drugs with no previously approved “active moiety,” instead of “active ingredient.” The agency defines active moiety as the molecule responsible for the physiological or pharmacological action of the drug.

A federal district court in 2015 said the FDA’s interpretation wasn’t consistent with statutory language, though it didn’t explicitly invalidate the regulations, according to a 2019 Congressional Research Service report.

The change could ...