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HR 1576 114th Congress House

Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

Official title: To require a study by the Government Accountability Office (GAO) to assess the Food and Drug Administration's current regulatory pathway for reviewing generic … Show full official titleShow less

Official title: To require a study by the Government Accountability Office (GAO) to assess the Food and Drug Administration's current regulatory pathway for reviewing generic versions of nonbiologic complex drug products, and for other purposes.

Introduced: March 24, 2015 See on congress.gov
Health Congressional oversightDrug safety, medical device, and laboratory regulationGovernment studies and investigationsPrescription 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 27, 2015
Referred to the Subcommittee on Health.
Mar 24, 2015
Referred to the House Committee on Energy and Commerce.
Mar 24, 2015
Introduced in House
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 Latest action March 27, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.)

If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 2
All 2 Republican 2
R
Hudson, Richard
North Carolina · Nov 5, 2015
 R
Bilirakis, Gus M.
Florida · Mar 24, 2015
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015. 114th Congress. Open America. https://openamerica.io/bill/114-HR-1576/
MLA
"H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-1576/.
Bluebook (legal)
H.R. 1576, 114th Cong. (2026), https://openamerica.io/bill/114-HR-1576/.
Markdown link
[H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015](https://openamerica.io/bill/114-HR-1576/)
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