S. 415 · 117th Congress

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

Introduced on Feb 24, 2021 by Bill Cassidy (R-LA). 2 cosponsors, 1 of them from another party. Became Public Law 117-9.

Stage
Became law
Public Law 117-9
Introduced
Feb 24, 2021
Cosponsors
2
1 from the other party
Policy area
Health
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Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. Reported by committee
  3. Passed one chamber
  4. Passed both chambers
  5. Sent to the President
  6. Became law

Subjects

  • Administrative law and regulatory procedures
  • Chemistry
  • Department of Health and Human Services
  • Drug safety, medical device, and laboratory regulation

Summary

By the Congressional Research Service (Public Law, Apr 23, 2021). Public domain.

This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases.

Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.

The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Bill CassidyR-LASponsor

Democrats · 1

Republicans · 1

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Feb 24, 2021Introduced in Senate
  2. Feb 24, 2021 · SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.
  3. Mar 10, 2021Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1435)
  4. Mar 10, 2021 · SenateSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)
  5. Mar 10, 2021Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1435)
  6. Mar 10, 2021 · SenatePassed Senate without amendment by Unanimous Consent. (text: CR S1435)
  7. Mar 11, 2021 · SenateMessage on Senate action sent to the House.
  8. Mar 12, 2021 · HouseReceived in the House.
  9. Mar 12, 2021 · HouseHeld at the desk.
  10. Apr 14, 2021 · HouseMr. Pallone moved to suspend the rules and pass the bill.
  11. Apr 14, 2021 · HouseConsidered under suspension of the rules. (consideration: CR H1755-1756)
  12. Apr 14, 2021 · HouseDEBATE - The House proceeded with forty minutes of debate on S. 415.
  13. Apr 14, 2021Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755)
  14. Apr 14, 2021 · HouseOn motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)
  15. Apr 14, 2021 · HouseMotion to reconsider laid on the table Agreed to without objection.
  16. Apr 20, 2021Presented to President.
  17. Apr 20, 2021 · HousePresented to President.
  18. Apr 23, 2021Signed by President.
  19. Apr 23, 2021Signed by President.
  20. Apr 23, 2021Became Public Law No: 117-9.
  21. Apr 23, 2021Became Public Law No: 117-9.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 5, 2026 · loaded Oct 5, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.