United States · Bill · HR
H.R. 1857 (117th)
Protecting Access to Safe and Effective Medicines Act of 2021
Introduced
11 March 2021
Last action
12 March 2021 · Referred
Status
Referred to the Subcommittee on Health.
Sponsors
Rep. Schrader, Kurt [D-OR-5], Rep. Guthrie, Brett [R-KY-2]
Subjects
Healthcare
Source updated
3 January 2025
Summary
Protecting Access to Safe and Effective Medicines Act of 2021 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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
11 March 2021
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
11 March 2021
Introduced
Introduced in House
Source: IntroReferral
11 March 2021
Introduced
Introduced in House
Source: IntroReferral
12 March 2021
Referred
Referred to the Subcommittee on Health.
Source: Committee
Votes
No vote records are attached yet.
Versions
- Introduced in House · 11 March 2021 · Download file
Documents
3 official files
Introduced in House (text)
This file cannot be previewed here. Use View or Download.
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in House (text)
Introduced in House · EN · 11 March 2021
Introduced in House (PDF)
Introduced in House · EN · 11 March 2021
ViewDownloadOpen at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in House
summary · EN · 11 March 2021
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Sponsors
- Rep. Schrader, Kurt [D-OR-5] · D · Sponsor
- Rep. Guthrie, Brett [R-KY-2] · R · Sponsor
- · hsif00 · Standing
Related records
- related to ← Lower Costs, More Cures Act of 2021
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/117th-congress/house-bill/1857
- Open data entity: https://api.congress.gov/v3/bill/117/hr/1857
- us · 117-hr-1857 · source updated 3 January 2025