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HR 1353 114th Congress House

PATIENT Act of 2015

Official title: To amend the Federal Food, Drug, and Cosmetic Act to extend the period of exclusivity with respect to certain drugs, and for other purposes.

Introduced: March 13, 2015 Introduced by: Bilirakis, Gus M. Republican · Florida See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationPrescription drugs
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) 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 20, 2015
Referred to the Subcommittee on Health.
Mar 13, 2015
Referred to the House Committee on Energy and Commerce.
Mar 13, 2015
Introduced in House
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 Latest action March 20, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or the PATIENT Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration.

A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to:

  • promote greater patient adherence to an approved treatment regime,
  • reduce the public health risks associated with the drug,
  • reduce side effects or adverse events,
  • provide benefits to the health-care system, or
  • provide other comparable patient benefits.
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Republican 1
R
Griffith, H. Morgan
Virginia · Mar 13, 2015
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 1353: PATIENT Act of 2015. 114th Congress. Open America. https://openamerica.io/bill/114-HR-1353/
MLA
"H.R. 1353: PATIENT Act of 2015." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-1353/.
Bluebook (legal)
H.R. 1353, 114th Cong. (2026), https://openamerica.io/bill/114-HR-1353/.
Markdown link
[H.R. 1353: PATIENT Act of 2015](https://openamerica.io/bill/114-HR-1353/)
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