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HR 5231 106th Congress House Health Administrative procedure Conflict of interests Department of Health and Human Services Drug approvals Federal preemption Foreign Trade and International Finance Genetic engineering Government Operations and Politics Government publicity Imports Intellectual property Inventions Law Local laws Patent infringement Patents Recombinant DNA Science, Technology, Communications State laws

Pharmaceutical Reform Act of 2000

Introduced: September 20, 2000 See on congress.gov
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This bill died when the 106th Congress ended
It never became law before the 106th Congress (1999–2000) 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 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 20, 2000
Referred to the Subcommittee on Health and Environment.
Sep 29, 2000
Referred to the Subcommittee on Courts and Intellectual Property.
Sep 20, 2000
Referred to the Committee on Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Sep 20, 2000
Introduced in House
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 Plain-English summary Congressional Research Service
Pharmaceutical Reform Act of 2000 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to cease consideration of, and to terminate, a petition to approve an abbreviated drug application for a new drug if the Secretary determines that the person submitting the petition received valuable consideration from an entity whose financial interests are served by an order approving such application.

Prohibits a patent from being considered to claim a listed drug unless, with respect to such drug, the patent claims an active ingredient.

Provides the effective date of the approval of an abbreviated application for a new drug containing a certification that its patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.

Prohibits any State or political subdivision from: (1) taking any action with respect to a drug approved under such Act that is different from or in addition to any listed requirement; or (2) establishing or continuing in effect a prohibition against the use of a drug as a substitute for any listed drug to which the drug is therapeutically equivalent.

Expresses the sense of Congress that a specified provision of the Public Health Service Act authorizes the submission of an abbreviated application for the approval of a new drug that is a biological product.

What's happening now October 20, 2000

Referred to the Subcommittee on Health and Environment.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 4
 Cosponsors 1
All 1 Republican 1
R
Calvert, Ken
California · Sep 20, 2000
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5231: Pharmaceutical Reform Act of 2000. 106th Congress. Open America. https://openamerica.io/bill/106-HR-5231/
MLA
"H.R. 5231: Pharmaceutical Reform Act of 2000." 106th Congress, 2026, Open America, https://openamerica.io/bill/106-HR-5231/.
Bluebook (legal)
H.R. 5231, 106th Cong. (2026), https://openamerica.io/bill/106-HR-5231/.
Markdown link
[H.R. 5231: Pharmaceutical Reform Act of 2000](https://openamerica.io/bill/106-HR-5231/)
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