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S 415 117th Congress Senate Health Administrative law and regulatory procedures Chemistry Department of Health and Human Services Drug safety, medical device, and laboratory regulation

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

Introduced: February 24, 2021 Introduced by: Cassidy, Bill Republican · Louisiana See on congress.gov
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 Everywhere this bill has been 18 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 23, 2021
Became Public Law No: 117-9.
Apr 23, 2021
Signed by President.
Apr 20, 2021
Presented to President.
Apr 14, 2021
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755)
Apr 14, 2021
DEBATE - The House proceeded with forty minutes of debate on S. 415.
Apr 14, 2021
Considered under suspension of the rules. (consideration: CR H1755-1756)
Apr 14, 2021
Mr. Pallone moved to suspend the rules and pass the bill.
Apr 14, 2021
Motion to reconsider laid on the table Agreed to without objection.
Apr 14, 2021
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)
Mar 12, 2021
Held at the desk.
Mar 12, 2021
Received in the House.
Mar 11, 2021
Message on Senate action sent to the House.
Mar 10, 2021
Passed Senate without amendment by Unanimous Consent. (text: CR S1435)
Mar 10, 2021
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1435)
Mar 10, 2021
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)
Mar 10, 2021
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1435)
Feb 24, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Feb 24, 2021
Introduced in Senate
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 Plain-English summary Congressional Research Service

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.

What's happening now April 23, 2021

Became Public Law No: 117-9.

 Bill text 4 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 2
All 2 Democratic 1 Republican 1
R
Marshall, Roger
Kansas · Feb 24, 2021
 D
Smith, Tina
Minnesota · Feb 24, 2021
Cite this page click to expand
APA
U.S. Congress. (2026). S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.. 117th Congress. Open America. https://openamerica.io/bill/117-S-415/
MLA
"S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-415/.
Bluebook (legal)
S. 415, 117th Cong. (2026), https://openamerica.io/bill/117-S-415/.
Markdown link
[S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.](https://openamerica.io/bill/117-S-415/)
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