S. 1636 · 116th Congress
Ensuring Innovation Act
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Passed the Senate without a recorded vote, then expired. It passed by voice vote or unanimous consent, which don't record how each member voted, but didn't become law before the 116th Congress ended.
R
RobertsSponsor2 cosponsors · 1 D, 1 R
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
- Senate Introduced May 23, 2019
- Senate Passed Dec 14, 2020
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.
What it does: CRS summary · Passed Senate · Dec 14, 2020
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Ensuring Innovation Act
Latest action (Dec 15, 2020): Held at the desk.
Policy area: Health · Origin: Senate · Introduced: May 23, 2019
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
- Senate Introduced May 23, 2019
- Senate Passed Dec 14, 2020
No recorded floor vote found.