GAAP Act of 2000
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Sep 21, 2000)
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 just happenedOct 20, 2000
Referred to the Subcommittee on Health and Environment.
Who’s behind it
- Introduced in HouseSep 21, 2000
- Oct 20, 2000CommitteeH11000
Referred to the Subcommittee on Health and Environment.
Health and Environment Subcommittee - Sep 21, 2000IntroReferralH11100
Referred to the House Committee on Commerce.
Energy and Commerce Committee - Sep 21, 2000IntroReferralIntro-H
Introduced in House
- Sep 21, 2000IntroReferral1000
Introduced in House