H.R. 5231 — Pharmaceutical Reform Act of 2000

Summary

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.

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Legislative Actions

2000-09-20
Introduced in House
2000-09-20
Introduced in House
2000-09-20
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.
2000-09-20
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.
2000-09-20
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.
2000-09-29
Referred to the Subcommittee on Courts and Intellectual Property.
2000-10-20
Referred to the Subcommittee on Health and Environment.

Pharmaceutical Reform Act of 2000

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