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HR 4538 116th Congress House

Closing Loopholes for Orphan Drugs Act

Official title: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.

Introduced: September 26, 2019 Introduced by: Welch, Peter Democratic · Vermont See on congress.gov
Health Drug therapyHealth care costs and insuranceInflation and pricesPrescription drugs
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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
Sep 27, 2019
Referred to the Subcommittee on Health.
Sep 26, 2019
Introduced in House
Sep 26, 2019
Referred to the House Committee on Energy and Commerce.
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 Latest action September 27, 2019

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Closing Loopholes for Orphan Drugs Act

This bill amends the Public Health Service Act to revise the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (i.e., drugs for rare conditions) for certain entities covered by the program. The bill discounts orphan drugs that are not being used to treat rare conditions for all entities covered by the program.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 4538: Closing Loopholes for Orphan Drugs Act. 116th Congress. Open America. https://openamerica.io/bill/116-HR-4538/
MLA
"H.R. 4538: Closing Loopholes for Orphan Drugs Act." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-4538/.
Bluebook (legal)
H.R. 4538, 116th Cong. (2026), https://openamerica.io/bill/116-HR-4538/.
Markdown link
[H.R. 4538: Closing Loopholes for Orphan Drugs Act](https://openamerica.io/bill/116-HR-4538/)
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