Greater Access to Affordable Pharmaceuticals Act of 2001
Latest action · May 7, 2002 Sponsor introductory remarks on measure. (CR H2110)
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMay 16, 2001
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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..
Cosponsors 62
Members who signed on, in the order they did. Signatures ran from May 16, 2001 to Sep 26, 2002; 10 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MA | Barney Frank | Original | May 16, 2001 |
| D-MI | Bart Stupak | Original | May 16, 2001 |
| I-VT | Bernard Sanders | Original | May 16, 2001 |
| D-NJ | Frank Pallone, Jr. | Original | May 16, 2001 |
| R-MO | Jo Ann Emerson | Original | May 16, 2001 |
| D-ME | John Elias Baldacci | Original | May 16, 2001 |
| D-FL | Karen L. Thurman | Original | May 16, 2001 |
| D-OH | Marcy Kaptur | Original | May 16, 2001 |
| D-MS | Ronnie Shows | Original | May 16, 2001 |
| D-ME | Thomas H. Allen | Original | May 16, 2001 |
| D-NY | Carolyn McCarthy | May 25, 2001 | |
| D-OR | Peter A. DeFazio | May 25, 2001 | |
| D-MI | David E. Bonior | Jun 7, 2001 | |
| D-MA | James P. McGovern | Jun 7, 2001 | |
| D-RI | James R. Langevin | Jun 7, 2001 | |
| R-OH | Steven C. LaTourette | Jun 7, 2001 | |
| R-PA | Todd Russell Platts | Jun 7, 2001 | |
| D-CA | Bob Filner | Jun 12, 2001 | |
| D-OH | Dennis J. Kucinich | Jun 12, 2001 | |
| D-MI | James A. Barcia | Jun 12, 2001 | |
| D-TX | Martin Frost | Jun 12, 2001 | |
| D-PA | Robert A. Brady | Jun 12, 2001 | |
| D-NY | Louise McIntosh Slaughter | Jun 26, 2001 | |
| D-WV | Nick J. Rahall II | Jun 26, 2001 | |
| D-FL | Peter Deutsch | Jun 26, 2001 | |
| D-WI | Thomas M. Barrett | Jun 26, 2001 | |
| D-IL | Rod R. Blagojevich | Jun 28, 2001 | |
| D-GA | Cynthia A. McKinney | Jul 11, 2001 | |
| D-MA | John F. Tierney | Jul 11, 2001 | |
| D-CA | Lucille Roybal-Allard | Jul 11, 2001 | |
| D-MI | Dale E. Kildee | Jul 17, 2001 | |
| D-NY | Maurice D. Hinchey | Jul 17, 2001 | |
| R-NE | Doug Bereuter | Oct 2, 2001 | |
| D-PA | Frank Mascara | Oct 2, 2001 | |
| D-NY | Nita M. Lowey | Oct 2, 2001 | |
| D-OH | Ted Strickland | Nov 6, 2001 | |
| D-NY | Jerrold Nadler | Feb 13, 2002 | |
| D-IN | Julia Carson | Feb 13, 2002 | |
| D-MI | Lynn N. Rivers | Feb 13, 2002 | |
| D-WA | Brian Baird | Apr 10, 2002 | |
| D-MA | John W. Olver | Apr 10, 2002 | |
| D-NY | Joseph Crowley | Apr 10, 2002 | |
| D-CT | Rosa L. DeLauro | Apr 10, 2002 | |
| D-VI | Donna M. Christensen | May 22, 2002 | |
| D-DC | Eleanor Holmes Norton | May 22, 2002 | |
| R-TN | John J. Duncan, Jr. | May 22, 2002 | |
| D-NM | Tom Udall | May 22, 2002 | |
| R-SD | John Thune | Jun 4, 2002 | |
| D-CA | Lynn C. Woolsey | Jun 20, 2002 | |
| D-AR | Marion Berry | Jun 20, 2002 | |
| D-WI | Ron Kind | Jun 20, 2002 | |
| R-GA | Jack Kingston | Jul 9, 2002 | |
| D-NY | Steve Israel | Jul 9, 2002 | |
| D-AR | Mike Ross | Jul 22, 2002 | |
| D-RI | Patrick J. Kennedy | Jul 22, 2002 | |
| D-GU | Robert A. Underwood | Sep 11, 2002 | |
| D-CA | Adam B. Schiff | Sep 24, 2002 | |
| D-CA | Barbara Lee | Sep 24, 2002 | |
| D-NY | Carolyn B. Maloney | Sep 24, 2002 | |
| D-PA | Paul E. Kanjorski | Sep 24, 2002 | |
| D-WI | Tammy Baldwin | Sep 24, 2002 | |
| D-NY | Michael R. McNulty | Sep 26, 2002 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred May 16, 2001 |
| Health Subcommittee | Referred Jun 1, 2001 |
Actions 4
Everything that happened, newest first.
- May 7, 2002Sponsor introductory remarks on measure. (CR H2110)
- Jun 1, 2001Referred to the Subcommittee on Health.
- May 16, 2001Introduced in House
- May 16, 2001Referred to the House Committee on Energy and Commerce.
In the Congressional Record 6
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Discharge petition H7898 | — | Oct 11, 2002 |
| House | Discharge petition H7019 | — | Oct 3, 2002 |
| House | Discharge petition H6778 | — | Sep 26, 2002 |
| House | Debate and remarks H6377, H6378, H6379, H6380, H6381, H6387, H6390, H6393, H6394, H6398Discharge petition H6420 | Betty McCollum D-MN, Christopher Cox R-CA, Frank Pallone, Jr. D-NJ, Gerald D. Kleczka D-WI, Janice D. Schakowsky D-IL, Karen L. Thurman D-FL, Lynn C. Woolsey D-CA, Martin Frost D-TX, Maurice D. Hinchey D-NY, Sherrod Brown D-OH | Sep 19, 2002 |
| House | Debate and remarks H6268 | Sherrod Brown D-OH | Sep 17, 2002 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Printed hearings 2
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 107-140 | EXAMINING ISSUES RELATED TO COMPETITION IN THE PHARMACEUTICAL MARKETPLACE: A REVIEW OF THE FTC REPORT, GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION146 pages | Energy and Commerce Committee | Oct 9, 2002 |
| Serial No. 107-34 | RECENT DEVELOPMENTS WHICH MAY IMPACT CONSUMER ACCESS TO, AND DEMAND FOR, PHARMACEUTICALS239 pages | Energy and Commerce Committee | Jun 13, 2001 |
CRS reports 1
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 1
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| 97-856 | The Discharge Rule in the House: Recent Use in Historical Context Archived | Report | Apr 17, 2003 |
Related bills 2
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HRES 517 | Providing for consideration of the bill (H.R. 1862) to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals. | Procedurally related | Sep 19, 2002 |
| S 812 | Greater Access to Affordable Pharmaceuticals Act of 2002 | Identical bill | Sep 4, 2002 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals.
- Short Titles as Introduced
- Greater Access to Affordable Pharmaceuticals Act of 2001
Subjects
Assigned by the Library of Congress. Policy area: 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
- Health
- Intellectual property
- Judicial opinions
- Law
- Patents
- Pharmaceutical research
- Prescription pricing
- Restrictive trade practices
- Right of petition
- Science, Technology, Communications
Text 1
Each version as it was printed, newest first.
- May 16, 2001Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.