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HR 1857 117th Congress House Health Administrative law and regulatory procedures Chemistry Department of Health and Human Services Drug safety, medical device, and laboratory regulation

Protecting Access to Safe and Effective Medicines Act of 2021

Introduced: March 11, 2021 See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) 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 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 12, 2021
Referred to the Subcommittee on Health.
Mar 11, 2021
Referred to the House Committee on Energy and Commerce.
Mar 11, 2021
Introduced in House
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 Plain-English summary Congressional Research Service

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.

What's happening now March 12, 2021

Referred to the Subcommittee on Health.

 Related & companion bills 1
  • HR 19 Related bill Lower Costs, More Cures Act of 2021
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Republican 1
R
Guthrie, Brett
Kentucky · Mar 11, 2021
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021. 117th Congress. Open America. https://openamerica.io/bill/117-HR-1857/
MLA
"H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-1857/.
Bluebook (legal)
H.R. 1857, 117th Cong. (2026), https://openamerica.io/bill/117-HR-1857/.
Markdown link
[H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021](https://openamerica.io/bill/117-HR-1857/)
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