3.0.0 7 2023-01-15T21:34:05Z 2023-01-15T21:34:05Z Senate S S 2003-01-07 108 ssfi00 Finance Committee Senate Standing Referred to 2003-01-07T22:47:33Z 2003-01-07 ssfi00 Finance Committee Senate Read twice and referred to the Committee on Finance. IntroReferral 2003-01-07 Sponsor introductory remarks on measure. (CR 1/9/2003 S134) IntroReferral B00100 9 Library of Congress 2003-01-07 Introduced in Senate IntroReferral 10000 9 Library of Congress D000064 Sen. Daschle, Thomas A. [D-SD] THOMAS DASCHLE D SD ANDREW N R000361 Sen. Rockefeller, John D., IV [D-WV] JAY ROCKEFELLER D WV 2003-01-07 True S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2003-01-07 True S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. 2003-01-07 True K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2003-01-07 True C001041 Sen. Clinton, Hillary Rodham [D-NY] HILLARY CLINTON D NY R 2003-01-07 True A000069 Sen. Akaka, Daniel K. [D-HI] DANIEL AKAKA D HI KOHIKINA 2003-01-07 True C001042 Sen. Corzine, Jon S. [D-NJ] JON CORZINE D NJ S. 2003-01-07 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2003-01-07 True M000702 Sen. Mikulski, Barbara A. [D-MD] BARBARA MIKULSKI D MD ANN 2003-01-07 True L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2003-01-07 True L000261 Sen. Levin, Carl [D-MI] CARL LEVIN D MI MILTON 2003-01-07 True J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2003-01-07 True R000122 Sen. Reed, Jack [D-RI] John Reed D RI F. 2003-01-07 True S000064 Sen. Sarbanes, Paul S. [D-MD] PAUL SARBANES D MD SPYROS 2003-01-07 True D000596 Sen. Dayton, Mark [D-MN] MARK DAYTON D MN 2003-01-07 True L000123 Sen. Lautenberg, Frank R. [D-NJ] FRANK LAUTENBERG D NJ R. 2003-01-07 True R000146 Sen. Reid, Harry [D-NV] HARRY REID D NV M. 2003-01-07 True D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN 2003-01-09 False B000711 Sen. Boxer, Barbara [D-CA] BARBARA BOXER D CA 2003-01-09 False B001210 Sen. Byrd, Robert C. [D-WV] ROBERT BYRD D WV CARLYLE 2003-02-26 False N000032 Sen. Nelson, Bill [D-FL] CLARENCE NELSON D FL WILLIAM 2003-04-02 False Health Administrative procedure Ambulatory care Armed Forces and National Security Auditing Business records Canada Child health Civil Rights and Liberties, Minority Issues Commerce Communication in medicine Conflict of interests Congress Congressional reporting requirements Consent decrees Consumer education Consumer organizations Continuum of care Crime and Law Enforcement Department of Health and Human Services District of Columbia Drug advertising Drug approvals Drug industry Drug interactions Drug therapy Drugs Economics and Public Finance Education Electronic data interchange Emergency medicine Employee benefit plans Employee health benefits Families Federal Trade Commission Federal advisory bodies Federal aid to health facilities Fees Finance and Financial Sector Fines (Penalties) Fraud Generic drugs Government Operations and Politics Government trust funds Governmental investigations Grants-in-aid Health care fraud Health education Health information systems Health insurance Health insurance continuation Health maintenance organizations Health services administration Home care services Hospitals Housing and Community Development Immunosuppressive drugs Imports Independent regulatory commissions Information networks Injunctions Intellectual property Judicial opinions Judicial review Kidney diseases Labeling Labor and Employment Law Mail-order business Managed care Marketing Medicaid Medical economics Medical fees Medical records Medical statistics Medicare Medication abuse Medigap Metropolitan areas Patent infringement Patents Patients' rights Pharmaceutical research Pharmacies Prescription pricing Quality control Rebates Restrictive trade practices Retiree health benefits Right of petition Right of privacy Rural health Science, Technology, Communications Social Welfare Standards Surveys Technological innovations Territories (U.S.) Transplantation of organs, tissues, etc. Urban affairs Veterans' benefits Veterans' medical care Health 00 2003-01-07 Introduced in Senate 2006-11-28T17:35:40Z Provides for: (1) part D benefits under Medicare+Choice plans under Medicare part C (Medicare+Choice); and (2) Medicare cost-sharing and other assistance for low-income individuals.

Revises requirements for Medicare supplemental insurance policy (Medigap) benefit packages to conform to changes made by this Act.

Provides for coverage of immunosuppressive drugs for all Medicare beneficiaries under Medicare part B (Supplementary Medical Insurance).

Directs the Secretary of Health and Human Services to study and report to Congress on the feasibility and advisability of establishing a uniform format for pharmacy benefit cards provided to beneficiaries.

Expands the membership and duties of the Medicare Payment Advisory Commission (MEDPAC).

Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning the timing of generic drug availability.

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.

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 a civil action for infringement a bar to later action.

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 (forfeiture events) which delay or prevent the marketing of the generic drug.

Adds provisions on importation of prescription drugs and pediatric labeling of drugs and biological products.]]>

Prescription Drug Benefit and Cost Containment Act of 2003 Display Title Prescription Drug Benefit and Cost Containment Act of 2003 Official Title as Introduced A bill to amend title XVIII of the Social Security Act to provide coverage of outpatient prescription drugs under the medicare program and to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals, and for other purposes. Introduced in Senate IS Short Titles as Introduced Prescription Drug Benefit and Cost Containment Act of 2003 Introduced in Senate 2003-01-07T05:00:00Z 2003-01-07 Read twice and referred to the Committee on Finance. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.