S. 1636: Ensuring Innovation Act
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S. 1636: Ensuring Innovation Act
116th Congress · introduced 2019-05-23 · Health · Latest: Held at the desk.
federal
Follow this bill, step by step
- Where it came from: introduced 2019-05-23 · official record
- Who proposed it: Sen. Roberts, Pat [R-KS] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Held at the desk. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
Ensuring Innovation Act
Plain summary
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.
Congressional Research Service summary (Passed Senate), quoted unchanged (nonpartisan). Read the source.
What a vote does
A “Yea” vote
If it passes both chambers and is signed, it becomes law.
A “Nay” vote
If it is not passed, current law stays as it is.
PSI Sci description of the legislative step (not an opinion).
What does this mean? (plain words)
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The strongest published arguments
Arguments for (supporters)
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Arguments against (opponents)
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Alternatives
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Sen. Roberts, Pat [R-KS] · 2 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Tina Smith (D-MN), Bill Cassidy (R-LA)
No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.
Words on this page, explained (3)
- Authorization
- A law that creates or continues a government program and says what it may do, often with a suggested spending ceiling. An authorization alone does not provide money; a separate appropriation does.
- Bill
- A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
- Statute
- A written law passed by a legislature. A statute can be changed by a later law; changing a constitution needs an amendment.
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Passed Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-116s1636.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/116/s>
Record fed-us-cong116-s1636 · catalog fed-us-congress-bills-cong116 · updated 2026-11-15 by psicol fed-bills-cong116