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Greater Access to Affordable Pharmaceuticals Act of 2002

Introduced: May 1, 2001 Introduced by: Schumer, Charles E. Democratic · New York See on congress.gov
This bill died when the 107th Congress ended
It never became law before the 107th Congress (2001–2002) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 29 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 4, 2002
Received in the House.
Sep 4, 2002
Message on Senate action sent to the House.
Sep 4, 2002
Held at the desk.
Jul 31, 2002
Considered by Senate. (consideration: CR S7618-7651)
Jul 31, 2002
Passed/agreed to in Senate: Passed Senate with an amendment by Yea-Nay Vote. 78 - 21. Record Vote Number: 201.
Jul 31, 2002
Cloture invoked in Senate by Yea-Nay Vote. 66 - 33. Record Vote Number: 200.
Jul 31, 2002
Passed Senate with an amendment by Yea-Nay Vote. 78 - 21. Record Vote Number: 201.
Jul 30, 2002
Considered by Senate. (consideration: CR S7516-7551)
Jul 29, 2002
Cloture motion on the measure presented in Senate. (consideration: CR S7462)
Jul 29, 2002
Considered by Senate. (consideration: CR S7462)
Jul 26, 2002
Considered by Senate. (consideration: CR S7398-7413)
Jul 25, 2002
Considered by Senate. (consideration: CR S7327-7336, S7342-7350)
Jul 24, 2002
Considered by Senate. (consideration: CR S7249-7263, S7282-7291, S7292-7299)
Jul 23, 2002
Considered by Senate. (consideration: CR S7194-7218)
Jul 22, 2002
Considered by Senate. (consideration: CR S7127, S7134-7158)
Jul 18, 2002
Considered by Senate. (consideration: CR S6977-7016, S7019-7028)
Jul 17, 2002
Measure laid before Senate by motion.
Jul 17, 2002
Motion to proceed to consideration of measure agreed to in Senate by Unanimous Consent.
Jul 17, 2002
Cloture on the motion to proceed invoked in Senate by Yea-Nay Vote. 99 - 0. Record Vote Number: 178.
Jul 17, 2002
Motion to proceed to measure considered in Senate. (consideration: CR S6878-6931; text of measure as reported in Senate: CR S6884-6887)
Jul 16, 2002
Motion to proceed to measure considered in Senate. (consideration: CR S6818-6829, S6831-6853)
Jul 15, 2002
Cloture motion on the motion to proceed to the measure presented in Senate.
Jul 15, 2002
Motion to proceed to consideration of measure made in Senate. (consideration: CR S6797-6801)
Jul 11, 2002
Placed on Senate Legislative Calendar under General Orders. Calendar No. 491.
Jul 11, 2002
Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment. Without written report.
Jul 11, 2002
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
May 1, 2001
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 1, 2001
Sponsor introductory remarks on measure. (CR S3590-3591)
May 1, 2001
Introduced in Senate
 Amendments to this bill 39

Amendments propose changes to this bill. Members vote on amendments separately before the final bill vote. An agreed amendment becomes part of the bill; a failed amendment does not.

6 agreed to 33 pending / other

AmendmentSponsorPurposeStatusLatest action
SAMDT 4,345 To amend title XVIII of the Social Security Act to provide protection for all medicare beneficiaries against … Ruled out of order Jul 31, 2002
SAMDT 4,299 To permit commercial importation of prescription drugs from Canada. Agreed to Jul 31, 2002
SAMDT 4,326 McConnell, Mitch To provide for health care liability reform. Agreed to Jul 30, 2002
SAMDT 4,316 To provide temporary State fiscal relief. Agreed to Jul 25, 2002
SAMDT 4,315 To provide medicare beneficiaries with a drug discount card that ensures access to affordable outpatient pres… Ruled out of order Jul 24, 2002
SAMDT 4,310 Grassley, Chuck To amend title XVIII of the Social Security Act to provide for a medicare voluntary prescription drug deliver… Withdrawn Jul 23, 2002
SAMDT 4,309 To amend title XVIII of the Social Security Act to provide coverage of outpatient prescription drugs under th… Withdrawn Jul 23, 2002
SAMDT 4,305 To clarify that section 1927 of the Social Security Act does not prohibit a State from entering into drug reb… Agreed to Jul 18, 2002
SAMDT 4,301 To protect the health and safety of Americans. Agreed to Jul 17, 2002
SAMDT 4,300 Of a perfecting nature. Agreed to Jul 17, 2002
SAMDT 4,349 Pending
SAMDT 4,344 Pending
SAMDT 4,343 Pending
SAMDT 4,342 Pending
SAMDT 4,341 Pending
SAMDT 4,340 Pending
SAMDT 4,339 Pending
SAMDT 4,338 Pending
SAMDT 4,337 Pending
SAMDT 4,336 Pending
SAMDT 4,335 Pending
SAMDT 4,334 Pending
SAMDT 4,333 Pending
SAMDT 4,332 Pending
SAMDT 4,331 Pending
SAMDT 4,330 Pending
SAMDT 4,329 Durbin, Richard J. Pending
SAMDT 4,328 Pending
SAMDT 4,327 Pending
SAMDT 4,325 Durbin, Richard J. Pending
SAMDT 4,318 Pending
SAMDT 4,317 Pending
SAMDT 4,314 Pending
SAMDT 4,313 Pending
SAMDT 4,308 Pending
SAMDT 4,307 Pending
SAMDT 4,304 Pending
SAMDT 4,303 Pending
SAMDT 4,302 Pending
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 Plain-English summary Congressional Research Service
Title I: Greater Access to Affordable Pharmaceuticals - Greater Access to Affordable Pharmaceuticals Act of 2002 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning the timing of generic drug availability.

(Sec. 103) Requires applicants (pharmaceutical companies) to register their patents with the Food and Drug Administration (FDA) within 30 days of approval (or issuance for subsequently issued patents).

Makes failure to timely register a bar to civil actions for patent infringement.

Requires applications for new drugs (NDA) or abbreviated new drug applications (ANDA) which rely upon investigations not conducted by or for the applicant and which concern a patent that claims both the drug and a method of use or more than one method of use to include a certification on a claim-by-claim basis that the patent is invalid or will not be infringed (known as a Paragraph IV filing/certification) by the new drug's (generic) manufacture and a statement regarding the method(s) of use claim.

(Sec. 104) Prohibits (for subsequently issued patents) an extension of the 30 month stay of FDA approval for any new drug where an ANDA or NDA contains a Paragraph IV filing/certification and the patent holder indicates an intention to bring a patent infringement suit against the new (generic) drug's manufacturer.

Makes failure to timely file (within 45 days of notice of a Paragraph IV filing) a civil action for infringement a bar to later action.

(Sec. 105) Requires the first generic applicant with a Paragraph IV filing to forfeit the 180 day marketing exclusivity period to a subsequent generic applicant if the first generic applicant engages in certain behaviors which cause the generic drug not to be brought timely to market.

(Sec. 106) Revises notice requirements for Paragraph IV filings to include and protect certain proposed formulation, composition, or method of use information.

Excludes an applicants's ability to pay damages from a court's consideration of whether or not to provide injunctive relief before the expiration of the 30 month stay of approval period.

(Sec. 107) Continues existing regulations and authorities regarding the bioequivalence of drugs and biological products.

(Sec. 108) Requires the Federal Trade Commission to report to Congress on how this Act has brought generic drugs to market faster.

(Sec. 109) Makes technical and conforming amendments.

Title II: Importation of Prescription Drugs - Amends the Federal Food, Drug, and Cosmetic Act to permit pharmacists and wholesalers to import (reimport) U.S. made prescription drugs into the United States from Canada.

Requires an importer to keep detailed records, including a drug's formulation, lot or control number, chain of distribution, and laboratory records.

Requires Canadian sellers to register with the Secretary. Directs the Secretary to suspend the importation of a drug or importations by a particular importer if a pattern emerges which suggests a risk to public health through counterfeit or other violations.

Prohibits drug manufacturers from offering pharmacists and wholesalers terms less favorable than those offered to a foreign purchaser. Prohibits a manufacturer from restricting access to a prescription drug that is permitted to be imported into the United States.

Declares that enforcement efforts concerning importation of prescription drugs by individuals should focus on significant threats to public health rather than importation that is clearly for personal use, particularly importation from Canada.

Provides for studies and reports to Congress by the National Academy of Sciences' Institute of Medicine and the Comptroller General concerning the effects of this Act, addressing compliance issues as well as its effect on trade, patent rights, and pricing.

Authorizes appropriations.

(Sec. 202) Amends title IX of the Social Security Act (Medicaid ) to permit States to enter into Medicaid-like drug rebate agreements with drug manufacturers on behalf of non-Medicaid residents.

(Sec. 203) Provides additional, temporary funding to States through the Medicaid FMAP (Federal medical assistance percentage) if a State plan's eligibility requirements are no more restrictive than those in effect on January 1, 2002. Increases the cap on Medicaid payments to the territories.

Amends title XX (Block Grants to States for Social Services) to provide State fiscal relief allotments, available through FY 2004.

What's happening now September 4, 2002

Held at the desk.

 Related & companion bills 1
 Bill text 3 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
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APA
U.S. Congress. (2026). S. 812: Greater Access to Affordable Pharmaceuticals Act of 2002. 107th Congress. Open America. https://openamerica.io/bill/107-S-812/
MLA
"S. 812: Greater Access to Affordable Pharmaceuticals Act of 2002." 107th Congress, 2026, Open America, https://openamerica.io/bill/107-S-812/.
Bluebook (legal)
S. 812, 107th Cong. (2026), https://openamerica.io/bill/107-S-812/.
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