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HR 4955 116th 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 2019

Introduced: October 31, 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 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 1, 2019
Referred to the Subcommittee on Health.
Oct 31, 2019
Referred to the House Committee on Energy and Commerce.
Oct 31, 2019
Introduced in House
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 Plain-English summary Congressional Research Service

Protecting Access to Safe and Effective Medicines Act of 2019

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 November 1, 2019

Referred to the Subcommittee on Health.

 Related & companion bills 3
  • S 1636 Related bill Ensuring Innovation Act
  • HR 19 Related bill Lower Costs, More Cures Act of 2019
  • S 1895 Related bill Lower Health Care Costs Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 3
All 3 Republican 2
R
Guthrie, Brett
Kentucky · Oct 31, 2019
 R
Hudson, Richard
North Carolina · Oct 31, 2019
Schrader, Kurt
· Oct 31, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-4955/
MLA
"H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-4955/.
Bluebook (legal)
H.R. 4955, 116th Cong. (2026), https://openamerica.io/bill/116-HR-4955/.
Markdown link
[H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019](https://openamerica.io/bill/116-HR-4955/)
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