S 812 in Congressional Session 107

Official Summary

 

Bill Number : S 812

 

Title : A bill to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals.

 

SUMMARY AS OF:
7/31/2002--Passed Senate amended.    (There is 1 other 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.

Votes

Title : A bill to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals.
Votes in the US Senate
Roll NumberVote DateQuestionDescriptionVote Result
2012002-07-31On Passage of the BillS. 812, as amended; Greater Access to Affordable Pharmaceuticals Act of 2002Passed
2002002-07-31On the Cloture MotionMotion to Invoke Cloture on S. 812; Greater Access to Affordable Pharmaceuticals Act of 2002Agreed to
1992002-07-31On the Motion S.Amdt. 4345Motion to Waive CBA re: Graham Amdt. No. 4345; To amend title XVIII of the Social Security Act to provide protection for all medicare beneficiaries against the costs of prescription drugs.Rejected
1972002-07-30On the Motion to Table S.Amdt. 4326Motion to Table McConnell Amdt. No. 4326; To provide for health care liability reform.Agreed to
1902002-07-25On the Motion S.Amdt. 4316Motion to Waive CBA re: Rockefeller Amdt. No. 4316; To provide temporary State fiscal relief.Agreed to
1892002-07-24On the Motion S.Amdt. 4315Motion to Waive CBA re: Hagel Amdt. No. 4315; To provide medicare beneficiaries with a drug discount card that ensures access to affordable outpatient prescription drugs.Rejected
1872002-07-23On the Motion S.Amdt. 4310Motion to Waive CBA re: Grassley Amdt. No. 4310; To 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.Rejected
1862002-07-23On the Motion S.Amdt. 4309Motion to Waive CBA re: Graham Amdt. No. 4309; To amend title XVIII of the Social Security Act to provide coverage of outpatient prescription drugs under the medicare program.Rejected
1822002-07-18On the Amendment S.Amdt. 4305Stabenow Amendment No. 4305, as modified; To 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.Agreed to
1802002-07-17On the Amendment S.Amdt. 4301Cochran Amendment No. 4301; To protect the health and safety of Americans.Agreed to
1792002-07-17On the Amendment S.Amdt. 4300Dorgan Amendment No. 4300; Of a perfecting nature.Agreed to
1782002-07-17On the Cloture MotionMotion to Invoke Cloture on the Motion to Proceed to Consider S. 812; Greater Access to Affordable Pharmaceuticals Act of 2002Agreed to
Votes in the US House
This Bill was not Voted in the US House

Sponsors

 
Congressional Sponsors of S 812
 
Bill Number : S 812

Title : A bill to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals.

Sponsor: Sen Schumer, Charles E. [NY] (introduced 5/1/2001)      

ALPHABETICAL [followed by Cosponsors withdrawn]:     (Sort: by date)

    Sen Carnahan, Jean [MO] - 4/23/2002

    Sen Clinton, Hillary Rodham [NY] - 4/10/2002

    Sen Daschle, Thomas A. [SD] - 5/1/2002

    Sen Durbin, Richard [IL] - 5/1/2002

    Sen Edwards, John [NC] - 6/4/2002

    Sen Feingold, Russell D. [WI] - 7/23/2002

    Sen Johnson, Tim [SD] - 6/8/2001

    Sen Kohl, Herb [WI] - 4/23/2002

    Sen McCain, John [AZ] - 5/1/2001

    Sen Miller, Zell [GA] - 6/19/2002

    Sen Stabenow, Debbie [MI] - 4/23/2002

    Sen Wellstone, Paul D. [MN] - 5/22/2002

Other Info

Bill Number : S 812

Title : A bill to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals.

 

 
ALL ACTIONS:
 
5/1/2001:Sponsor introductory remarks on measure. (CR S3590-3591)
 
5/1/2001:Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
 
7/11/2002:Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
 
7/11/2002:Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment. Without written report.
 
7/11/2002:Placed on Senate Legislative Calendar under General Orders. Calendar No. 491.
 
7/15/2002:Motion to proceed to consideration of measure made in Senate. (consideration: CR S6797-6801)
 
7/15/2002:Cloture motion on the motion to proceed to the measure presented in Senate.
 
7/16/2002:Motion to proceed to measure considered in Senate. (consideration: CR S6818-6829, S6831-6853)
 
7/17/2002:Motion to proceed to measure considered in Senate. (consideration: CR S6878-6931; text of measure as reported in Senate: CR S6884-6887)
 
7/17/2002:Cloture on the motion to proceed invoked in Senate by Yea-Nay Vote. 99 - 0. Record Vote Number: 178.
 
7/17/2002:Motion to proceed to consideration of measure agreed to in Senate by Unanimous Consent.
 
7/17/2002:Measure laid before Senate by motion.
 
7/18/2002:Considered by Senate. (consideration: CR S6977-7016, S7019-7028)
 
7/22/2002:Considered by Senate. (consideration: CR S7127, S7134-7158)
 
7/23/2002:Considered by Senate. (consideration: CR S7194-7218)
 
7/24/2002:Considered by Senate. (consideration: CR S7249-7263, S7282-7291, S7292-7299)
 
7/25/2002:Considered by Senate. (consideration: CR S7327-7336, S7342-7350)
 
7/26/2002:Considered by Senate. (consideration: CR S7398-7413)
 
7/29/2002:Considered by Senate. (consideration: CR S7462)
 
7/29/2002:Cloture motion on the measure presented in Senate. (consideration: CR S7462)
 
7/30/2002:Considered by Senate. (consideration: CR S7516-7551)
 
7/31/2002:Considered by Senate. (consideration: CR S7618-7651)
 
7/31/2002:Cloture invoked in Senate by Yea-Nay Vote. 66 - 33. Record Vote Number: 200.
 
7/31/2002:Passed Senate with an amendment by Yea-Nay Vote. 78 - 21. Record Vote Number: 201.
 
9/4/2002:Message on Senate action sent to the House.
 
9/4/2002 2:01pm:Received in the House.
 
9/4/2002 8:01pm:Held at the desk.