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117-s-415117th CongressWALLET

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.

Sponsored By: Senator Cassidy, Bill [R-LA]

Became Law

Summary

This law refocuses drug exclusivity and related incentives by shifting the legal test from an 'active ingredient' standard to the Secretary's 'active moiety' definition in 21 C.F.R. 314.3. It applies that moiety-based test across drug, biologic, veterinary, and rare pediatric-disease rules and updates cross-references for consistency.

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  • Drug and biologic developers: The standard for new chemical exclusivity and related protections now depends on whether a product contains an approved active moiety. That changes which earlier approvals block exclusivity for follow-on drugs and biologics.
  • Patients and rare-disease sponsors: Rare pediatric disease designations and incentives now hinge on whether a product's active moiety has been previously approved, not on broader "active ingredient" language. This alters eligibility for certain pediatric incentives.
  • FDA procedures and the statute: The law requires FDA advisory committee review for products with no approved active moiety elsewhere, and it forces the agency to explain in approval letters if it skips referral. The act also makes several technical fixes to statutory cross-references to align the new moiety framework.

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 1 benefits, 0 costs, 2 mixed.

Drug exclusivity now uses active moiety

The law changes FDA rules to use the drug’s active moiety, not the broader active ingredient, to decide exclusivity. It applies to human and animal drugs and follows the FDA definition in 21 C.F.R. 314.3. The law also removes two clauses in section 505 tied to the old wording. This can change how long brand drugs keep exclusivity and when generics can enter. These updates take effect upon enactment.

More FDA checks on new drugs

The FDA must send drugs or biologics with a new active moiety or ingredient to an advisory panel before approval. If it does not, the approval letter must explain why. Within 30 days after approval, the FDA checks if the drug’s active moiety or the biologic’s active ingredient was already approved. These steps add expert review and clearer exclusivity decisions. They apply upon enactment.

New rules for orphan and pediatric drugs

The law ties orphan and rare pediatric eligibility to what was previously approved. For drugs, the product must have no previously approved active moiety and use the full approval path. For biologics, it must have no previously approved active ingredient and use the full path. These rules change who can get these incentives. They apply upon enactment.

Sponsors & CoSponsors

Sponsor

Cassidy, Bill [R-LA]

LA • R

Cosponsors

  • Sen. Smith, Tina [D-MN]

    MN • D

    Sponsored 2/24/2021

  • Sen. Marshall, Roger [R-KS]

    KS • R

    Sponsored 2/24/2021

Roll Call Votes

No roll call votes available for this bill.

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