Skip to main content
HR 1862 107th Congress House Health Administrative procedure Administrative remedies Civil actions and liability Commerce Competition Congress Congressional reporting requirements Consent decrees Department of Health and Human Services Drug approvals Drug industry Generic drugs Government Operations and Politics Government paperwork Governmental investigations Intellectual property Judicial opinions Law Patents

Greater Access to Affordable Pharmaceuticals Act of 2001

Introduced: May 16, 2001 See on congress.gov
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 7, 2002
Sponsor introductory remarks on measure. (CR H2110)
Jun 1, 2001
Referred to the Subcommittee on Health.
May 16, 2001
Referred to the House Committee on Energy and Commerce.
May 16, 2001
Introduced in House
 Plain-English summary Congressional Research Service
Greater Access to Affordable Pharmaceuticals Act of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to provide for an accelerated date of approval for a generic drug application.

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.

Sets forth requirements concerning the filing of a citizen petition review.

Revises provisions concerning: (1) abbreviated new drug applications and new drug applications with respect to the time required for approval and the certification that a patent is invalid or will not be infringed; and (2) filing an application.

Requires a report concerning the extent to which this Act has: (1) has enabled products to come to market in a fair and expeditious manner, consistent with the rights of patent owners under intellectual property law; and (2) has promoted lower prices of drugs and greater access to drugs through price competition..

What's happening now May 7, 2002

Sponsor introductory remarks on measure. (CR H2110)

 Committees of jurisdiction 2