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S 3051 106th Congress Senate Health Administrative procedure Commerce Department of Health and Human Services Drug approvals Drug industry Generic drugs Government Operations and Politics Intellectual property Law Patents Pharmaceutical research Prescription pricing Right of petition Science, Technology, Communications

GAAP Act of 2000

Introduced: September 14, 2000 Introduced by: Schumer, Charles E. Democratic · New York See on congress.gov
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 14, 2000
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S8590)
Sep 14, 2000
Introduced in Senate
 Plain-English summary Congressional Research Service
Greater Access to Affordable Pharmaceuticals Act or GAAP Act of 2000 - Amends the Federal Food, Drug, and Cosmetic Act to include in a required abbreviated new drug application information concerning certification of each patent which claims any active ingredient for a listed drug (currently, only the listed drug itself), either alone or in combination with other active ingredients, or which claims the first approved use for such drug for which an applicant is seeking approval.

States that the filing of a citizen petition review shall not cause the Secretary of Health and Human Services to delay review and approval of an abbreviated new drug application unless the petition demonstrates through substantial scientific proof that approval would pose a threat to public health and safety.

Allows a drug to be considered a bioequivalent to a listed drug if the effects of such drug and the listed drug do not show a significant difference based on certain tests or studies.

Provides for an accelerated date of approval of a generic drug application.

Expresses the sense of Congress that measures should be taken to effectuate the purpose of the Drug Price Competition and Patent Term Restoration Act of 1984 to make generic drugs more available and accessible, thereby reducing health care costs.

What's happening now September 14, 2000

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S8590)

 Committees of jurisdiction 1