S 7 · 108th Congress 2003–2005, ended

Prescription Drug Benefit and Cost Containment Act of 2003

Introduced Jan 7, 2003 Originated Senate Sponsor Thomas A. Daschle D-SD

Fact sheet

Latest action · Jan 7, 2003 Read twice and referred to the Committee on Finance.

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. IntroducedJan 7, 2003
  2. Passed SenateNot reached
  3. Passed HouseNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Prescription Drug Benefit and Cost Containment Act of 2003 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to establish: (1) a Medicare Outpatient Prescription Drug Benefit Program under new part D; (2) a Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund; and (3) a Medicare Prescription Drug Advisory Committee.

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.

Cosponsors 21

Members who signed on, in the order they did. Signatures ran from Jan 7, 2003 to Apr 2, 2003, with 17 there on the day it was introduced.

SeatCosponsorSigned on
D-MDBarbara A. MikulskiOriginalJan 7, 2003
D-MICarl LevinOriginalJan 7, 2003
D-NYCharles E. SchumerOriginalJan 7, 2003
D-HIDaniel K. AkakaOriginalJan 7, 2003
D-MIDebbie StabenowOriginalJan 7, 2003
D-MAEdward M. KennedyOriginalJan 7, 2003
D-NJFrank R. LautenbergOriginalJan 7, 2003
D-NVHarry ReidOriginalJan 7, 2003
D-NYHillary Rodham ClintonOriginalJan 7, 2003
D-RIJack ReedOriginalJan 7, 2003
D-WVJohn D. Rockefeller IVOriginalJan 7, 2003
D-NJJon S. CorzineOriginalJan 7, 2003
D-MNMark DaytonOriginalJan 7, 2003
D-VTPatrick J. LeahyOriginalJan 7, 2003
D-MDPaul S. SarbanesOriginalJan 7, 2003
Show all 21 cosponsors

Actions 3

Everything that happened, newest first.

  1. Jan 7, 2003Introduced in Senate
  2. Jan 7, 2003Read twice and referred to the Committee on Finance.
  3. Jan 7, 2003Sponsor introductory remarks on measure. (CR 1/9/2003 S134)

Subjects

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

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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.