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HR 5334 112th Congress House

To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.

Introduced: May 7, 2012 See on congress.gov
Health Administrative law and regulatory proceduresCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) 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
May 11, 2012
Referred to the Subcommittee on Health.
May 7, 2012
Referred to the House Committee on Energy and Commerce.
May 7, 2012
Introduced in House
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 Latest action May 11, 2012

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval.

Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.

Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations.

Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.

 Related & companion bills 4
  • HR 5651 Related bill Food and Drug Administration Reform Act of 2012
  • S 2236 Related bill Advancing Breakthrough Therapies for Patients Act of 2012
  • S 2516 Related bill Food and Drug Administration Safety and Innovation Act
  • S 3187 Related bill Food and Drug Administration Safety and Innovation Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1
D
DeGette, Diana
Colorado · May 7, 2012
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5334: To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.. 112th Congress. Open America. https://openamerica.io/bill/112-HR-5334/
MLA
"H.R. 5334: To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-5334/.
Bluebook (legal)
H.R. 5334, 112th Cong. (2026), https://openamerica.io/bill/112-HR-5334/.
Markdown link
[H.R. 5334: To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.](https://openamerica.io/bill/112-HR-5334/)
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