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S 1636 116th Congress Senate Health Administrative law and regulatory procedures Chemistry Department of Health and Human Services Drug safety, medical device, and laboratory regulation

Ensuring Innovation Act

Introduced: May 23, 2019 See on congress.gov
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 9 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 15, 2020
Held at the desk.
Dec 15, 2020
Received in the House.
Dec 15, 2020
Message on Senate action sent to the House.
Dec 14, 2020
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7470)
Dec 14, 2020
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7470)
Dec 14, 2020
Measure laid before Senate by unanimous consent. (consideration: CR S7470)
Dec 14, 2020
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
May 23, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 23, 2019
Introduced in Senate
 Amendments to this bill 1

1 agreed to

AmendmentSponsorPurposeStatusLatest action
SAMDT 2,707 — In the nature of a substitute. Agreed to Dec 14, 2020
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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 December 15, 2020

Held at the desk.

 Related & companion bills 3
  • HR 4955 Related bill Protecting Access to Safe and Effective Medicines Act of 2019
  • HR 19 Related bill Lower Costs, More Cures Act of 2019
  • S 1895 Related bill Lower Health Care Costs Act
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 2
All 2 Democratic 1 Republican 1
R
Cassidy, Bill
Louisiana · May 23, 2019
 D
Smith, Tina
Minnesota · May 23, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1636: Ensuring Innovation Act. 116th Congress. Open America. https://openamerica.io/bill/116-S-1636/
MLA
"S. 1636: Ensuring Innovation Act." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-S-1636/.
Bluebook (legal)
S. 1636, 116th Cong. (2026), https://openamerica.io/bill/116-S-1636/.
Markdown link
[S. 1636: Ensuring Innovation Act](https://openamerica.io/bill/116-S-1636/)
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