# 117-s-415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.

117-s-415, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity., is a 117th Congress bill sponsored by Sen. Cassidy, Bill [R-LA] (R-LA); status became_law; PRIA reads it as touching household money (as of 2026-01-05).

- Canonical: https://policyrisk.com/legislation/117-s-415
- As of: 2026-01-05
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 117-s-415
- Congress: 117
- Title: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
- Status: became_law
- Introduced: 2021-02-24
- Sponsor: Sen. Cassidy, Bill [R-LA] (R-LA)
- Cosponsors: 2
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-01-05

## 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. - 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.

## Cosponsors (2)

- Sen. Smith, Tina [D-MN] (D-MN), 2021-02-24T00:00:00.000Z
- Sen. Marshall, Roger [R-KS] (R-KS), 2021-02-24T00:00:00.000Z

## Provisions PRIA read

- More FDA checks on new drugs: benefit, medium. 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.…
- Drug exclusivity now uses active moiety: mixed, high. 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 l…
- New rules for orphan and pediatric drugs: mixed, medium. 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 wh…

## Related bills

- 117-s-610: Protecting Medicare and American Farmers from Sequester Cuts Act
- 117-sres-817: A resolution expressing support for the designation of October 2 through October 8, 2022, as "National 4-H Week".
- 117-sres-762: A resolution honoring the life and accomplishments of Queen Elizabeth II and expressing condolences to her family and the United Kingdom on her passing.
- 117-sres-748: A resolution honoring and celebrating the life and legacy of Representative Jackie Walorski.
- 117-s-4587: Benjamin Berell Ferencz Congressional Gold Medal Act
- 117-s-4202: Alzheimer’s Accountability and Investment Act

## Sources
- [117-s-415 on Congress.gov](https://www.congress.gov/bill/117th-congress/senate-bill/415)

## Related
- [117-s-610: Protecting Medicare and American Farmers from Sequester Cuts Act](https://policyrisk.com/legislation/117-s-610)
- [117-sres-817: A resolution expressing support for the designation of October 2 through Octobe…](https://policyrisk.com/legislation/117-sres-817)
- [117-sres-762: A resolution honoring the life and accomplishments of Queen Elizabeth II and ex…](https://policyrisk.com/legislation/117-sres-762)
- [117-sres-748: A resolution honoring and celebrating the life and legacy of Representative Jac…](https://policyrisk.com/legislation/117-sres-748)
- [117-s-4587: Benjamin Berell Ferencz Congressional Gold Medal Act](https://policyrisk.com/legislation/117-s-4587)
- [117-s-4202: Alzheimer’s Accountability and Investment Act](https://policyrisk.com/legislation/117-s-4202)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/117-s-415 (as of 2026-01-05).