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Greater Access to Affordable Pharmaceuticals Act of 2001

1/16/2023, 3:33 PM

Congressional Summary of HR 1862

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..

Read the Full Bill

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Current Status of Bill HR 1862

Bill HR 1862 is currently in the status of Bill Introduced since May 16, 2001. Bill HR 1862 was introduced during Congress 107 and was introduced to the House on May 16, 2001.  Bill HR 1862's most recent activity was Sponsor introductory remarks on measure. (CR H2110) as of May 7, 2002

Bipartisan Support of Bill HR 1862

Total Number of Sponsors
1
Democrat Sponsors
1
Republican Sponsors
0
Unaffiliated Sponsors
0
Total Number of Cosponsors
62
Democrat Cosponsors
54
Republican Cosponsors
7
Unaffiliated Cosponsors
1

Policy Area and Potential Impact of Bill HR 1862

Primary Policy Focus

Health

Potential Impact Areas

- 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
- Pharmaceutical research
- Prescription pricing
- Restrictive trade practices
- Right of petition
- Science, Technology, Communications

Alternate Title(s) of Bill HR 1862

Greater Access to Affordable Pharmaceuticals Act of 2001
To amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals.
Greater Access to Affordable Pharmaceuticals Act of 2001

Comments

Sponsors and Cosponsors of HR 1862

Sherrod Brown
Sherrod Brown
OhioDemocrat
Lynn C. Woolsey
Lynn C. Woolsey
CaliforniaDemocrat
Tom Udall
Tom Udall
New MexicoDemocrat
Robert A. Underwood
Robert A. Underwood
GuamIndependent
John F. Tierney
John F. Tierney
MassachusettsDemocrat
Karen L. Thurman
Karen L. Thurman
FloridaIndependent

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