S 812 · 107th Congress 2001–2003, ended

Greater Access to Affordable Pharmaceuticals Act of 2002

Introduced May 1, 2001 Originated Senate Sponsor Charles E. Schumer D-NY

Fact sheet Spreadsheet

Latest action · Sep 4, 2002 Held at the desk.

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.

  1. IntroducedMay 1, 2001
  2. Passed SenateJul 31, 2002
  3. Passed HouseNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

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.

Recorded votes 3

Newest first. Open one to see how every member voted.

Roll callQuestionResultDate
Senate 201Bill Passed78–21Jul 31, 2002
Senate 200Cloture Motion Agreed to66–33Jul 31, 2002
Senate 178Cloture Motion Agreed to99–0Jul 17, 2002

Cosponsors 12

Members who signed on, in the order they did. Signatures ran from May 1, 2001 to Jul 23, 2002; 1 is an original cosponsor, there from the day it was introduced.

SeatCosponsorSigned on
R-AZJohn McCainOriginalMay 1, 2001
D-SDTim JohnsonJun 8, 2001
D-NYHillary Rodham ClintonApr 10, 2002
D-MIDebbie StabenowApr 23, 2002
D-WIHerb KohlApr 23, 2002
D-MOJean CarnahanApr 23, 2002
D-ILRichard J. DurbinMay 1, 2002
D-SDThomas A. DaschleMay 1, 2002
D-MNPaul D. WellstoneMay 22, 2002
D-NCJohn EdwardsJun 4, 2002
D-GAZell MillerJun 19, 2002
D-WIRussell D. FeingoldJul 23, 2002

Committees 1

Where it was sent and what each committee and subcommittee did with it, in order.

ChamberCommitteeWhat it did
SenateHealth, Education, Labor, and Pensions Committee
Referred May 1, 2001Markup Jul 11, 2002Reported Jul 11, 2002

Actions 28

Everything that happened, newest first.

  1. Sep 4, 2002Message on Senate action sent to the House.
  2. Sep 4, 2002Received in the House.
  3. Sep 4, 2002Held at the desk.
  4. Jul 31, 2002Considered by Senate. (consideration: CR S7618-7651)
  5. Jul 31, 2002Cloture invoked in Senate by Yea-Nay Vote. 66 - 33. Record Vote Number: 200.
Show all 28 actions

In the Congressional Record 18

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.

WhereIn the RecordMembersDate
SenateDebate and remarks S10407Debbie Stabenow D-MIOct 15, 2002
SenateDebate and remarks S9182Debbie Stabenow D-MISep 25, 2002
SenateDebate and remarks S8630, S8631Debbie Stabenow D-MI, Richard J. Durbin D-ILSep 17, 2002
SenateAmendments S8093Debbie Stabenow D-MI (amendment)Sep 3, 2002
SenateDebate and remarks S7849–S7851, S7853–S7858, S7875–S7878Text printed S8007–S8012Bill Nelson D-FL, Bob Graham D-FL, Don Nickles R-OK, Orrin G. Hatch R-UTAug 1, 2002
Show all 18 days

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 9

Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.

NumberHearingCommitteeHeld
Serial No. 107-140EXAMINING ISSUES RELATED TO COMPETITION IN THE PHARMACEUTICAL MARKETPLACE: A REVIEW OF THE FTC REPORT, GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION146 pagesEnergy and Commerce CommitteeOct 9, 2002
S. Hrg. 107-730NOMINATION60 pagesHealth, Education, Labor, and Pensions CommitteeOct 7, 2002
S. Hrg. 107-942OVERSIGHT OF ENFORCEMENT OF THE ANTITRUST LAWS179 pagesJudiciary CommitteeSep 19, 2002
Serial No. 107-136THE STEEL INDUSTRY LEGACY RELIEF ACT OF 200259 pagesEnergy and Commerce CommitteeSep 10, 2002
S. Hrg. 107-450CLOSING THE GAPS IN HATCH-WAXMAN: ASSURING GREATER ACCESS TO AFFORDABLE PHARMACEUTICALS65 pagesHealth, Education, Labor, and Pensions CommitteeMay 8, 2002
Show all 9 hearings

Amendments 39

Amendments offered to this bill.

AmendmentDescriptionOffered byStatus
SA 4299To permit commercial importation of prescription drugs from Canada.Byron L. Dorgan D-NDAmendment SA 4299 agreed to in Senate by Unanimous Consent.
SA 4300Of a perfecting nature.Byron L. Dorgan D-NDAmendment SA 4300 agreed to in Senate by Yea-Nay Vote. 69 - 30. Record Vote Number: 179.
SA 4301To protect the health and safety of Americans.Thad Cochran R-MSAmendment SA 4301 agreed to in Senate by Yea-Nay Vote. 99 - 0. Record Vote Number: 180.
SA 4302No description on fileCraig Thomas R-WYSenate amendment submitted
SA 4303No description on fileDianne Feinstein D-CASenate amendment submitted
SA 4304No description on fileBob Smith R-NHSenate amendment submitted
SA 4305To clarify that section 1927 of the Social Security Act does not prohibit a State from entering into drug rebate agreements in order to make outpatient prescription drugs accessible and affordable for residents of the State who are not otherwise eligible for medical assistance under the medicaid program.Debbie Stabenow D-MIAmendment SA 4305 as modified agreed to in Senate by Yea-Nay Vote. 56 - 43. Record Vote Number: 182. (text as modified: CR S6978)
SA 4307No description on fileBill Nelson D-FLSenate amendment submitted
SA 4308No description on fileRobert G. Torricelli D-NJSenate amendment submitted
SA 4309To amend title XVIII of the Social Security Act to provide coverage of outpatient prescription drugs under the medicare program.Bob Graham D-FLProposed amendment SA 4309 withdrawn in Senate.
SA 4310To amend title XVIII of the Social Security Act to provide for a medicare voluntary prescription drug delivery program under the medicare program, to modernize the medicare program, and for other purposes.Chuck Grassley R-IAProposed amendment SA 4310 withdrawn in Senate.
SA 4313No description on fileMike DeWine R-OHSenate amendment submitted
SA 4314No description on fileRussell D. Feingold D-WISenate amendment submitted
SA 4315To provide medicare beneficiaries with a drug discount card that ensures access to affordable outpatient prescription drugs.Chuck Hagel R-NEAmendment SA 4315 ruled out of order by the chair.
SA 4316To provide temporary State fiscal relief.John D. Rockefeller IV D-WVAmendment SA 4316 agreed to in Senate by Unanimous Consent.
SA 4317No description on fileHillary Rodham Clinton D-NYSenate amendment submitted
SA 4318No description on fileHillary Rodham Clinton D-NYSenate amendment submitted
SA 4325No description on fileRichard J. Durbin D-ILSenate amendment submitted
SA 4326To provide for health care liability reform.Mitch McConnell R-KYMotion to table amendment SA 4326 agreed to in Senate by Yea-Nay. 57 - 42. Record Vote Number: 197.
SA 4327No description on filePaul D. Wellstone D-MNSenate amendment submitted
SA 4328No description on fileJeff Bingaman D-NMSenate amendment submitted
SA 4329No description on fileRichard J. Durbin D-ILSenate amendment submitted
SA 4330No description on fileMichael B. Enzi R-WYSenate amendment submitted
SA 4331No description on fileMichael B. Enzi R-WYSenate amendment submitted
SA 4332No description on fileMichael B. Enzi R-WYSenate amendment submitted
SA 4333No description on fileMichael B. Enzi R-WYSenate amendment submitted
SA 4334No description on fileDon Nickles R-OKSenate amendment submitted
SA 4335No description on fileDon Nickles R-OKSenate amendment submitted
SA 4336No description on fileDon Nickles R-OKSenate amendment submitted
SA 4337No description on fileDon Nickles R-OKSenate amendment submitted
SA 4338No description on fileDon Nickles R-OKSenate amendment submitted
SA 4339No description on fileDon Nickles R-OKSenate amendment submitted
SA 4340No description on filePatrick J. Leahy D-VTSenate amendment submitted
SA 4341No description on fileMark Dayton D-MNSenate amendment submitted
SA 4342No description on fileWilliam H. Frist R-TNSenate amendment submitted
SA 4343No description on fileWilliam H. Frist R-TNSenate amendment submitted
SA 4344No description on fileWilliam H. Frist R-TNSenate amendment submitted
SA 4345To amend title XVIII of the Social Security Act to provide protection for all medicare beneficiaries against the costs of prescription drugs.Bob Graham D-FLAmendment SA 4345 ruled out of order by the chair.
SA 4349No description on fileTim Hutchinson R-ARSenate amendment submitted

Related bills 1

Companion bills and other measures the record links to this one.

BillTitleRelationshipLatest action
HR 1862Greater Access to Affordable Pharmaceuticals Act of 2001Identical billMay 7, 2002

Titles 4

Every title it has carried, official and short, at each stage.

Official Title as Introduced
A bill 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
Short Titles as Passed Senate
Greater Access to Affordable Pharmaceuticals Act of 2002
Popular Titles
Schumer-Edwards bill

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 3

Each version as it was printed, newest first.

  1. Jul 31, 2002Engrossed in Senate
  2. Jul 11, 2002Reported to Senate
  3. May 1, 2001Introduced in Senate

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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.