Lower PRICED Drugs Act

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes.

4/11/2007--Introduced.
Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement:
(1) that identifies the relevant patent and the approved use covered by the patent; and
(2) that the applicant is not seeking approval of such use. Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant. Limits market exclusivity provided for conducting pediatric studies of new or already approved drugs to only those drugs for which the Secretary of Health and Human Services approves labeling that provides specific, therapeutically meaningful information about the use of the drug in pediatric patients. Reduces market exclusivity for such studies for drugs with sales revenue that is $1 billion or more. Prohibits the Secretary from delaying approval of a new drug application while a petition seeking any action relating to such an application is being reviewed or considered. Requires the Secretary to take final agency action on a petition within 180 days of receipt, with no extensions allowed. Extends the 30-month period that the Secretary has to approve or disapprove an abbreviated application for a new drug by the amount of time that lapses from the date the Secretary receives a petition and the date of the final agency action on the petition, without regard to whether the Secretary grants or denies the petition.


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Sponsor

• Sen. Debbie Ann Stabenow [D, MI]
• and 3 Co-Sponsors
  • Sen. Herbert Kohl [D, WI]
  • Sen. Carl Levin [D, MI]
  • Trent Lott
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Committees

• Senate Health, Education, Labor, and Pensions

Amendments

This bill has no amendments.

Amendments to S.1088

Number	Status	Purpose

Bill Status

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Introduced		Voted on by Senate		Voted on by House		Considered By President		Bill Becomes Law
April 11, 2007

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All Bill Actions

• Introduced on Apr 11, 2007.
• Apr 11, 2007: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Related Issue Areas:

• Medicine
• Administrative remedies
• Antibiotics
• Business
• 20 more
• Children
• Clinical trials
• Consumer education
• Consumers
• Department of Health and Human Services
• Drug approvals
• Drug industry
• Drug utilization
• Executive departments
• Generic drugs
• Intellectual property
• Labeling
• Law
• Marketing
• Medical care
• Patent infringement
• Patents
• Pediatrics
• Prescription pricing
• Child health

Data from the Congressional Research Service

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Blog Coverage

December 11, 2008 Deutschland Archiv: Zeitschrift für das vereinigte Deutschland - H ...

Ulrich Mählert u. a. (Hg.): Jahrbuch für Historische Kommunismusforschung 2008 (Georg Wurzer) S. 1088. Vladislav M. Zubok: A Failed Empire (Hermann Wentker) S. 1089-1090. Silke Satjukow: Besatzer (Winfrid Halder) S. ...

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Source: H-Soz-u-Kult

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December 09, 2008 Deutschland Archiv: Zeitschrift für das vereinigte Deutschland - H ...

Ulrich Mählert u. a. (Hg.): Jahrbuch für Historische Kommunismusforschung 2008 (Georg Wurzer) S. 1088. Vladislav M. Zubok: A Failed Empire (Hermann Wentker) S. 1089-1090. Silke Satjukow: Besatzer (Winfrid Halder) S. 1091-1093 ...

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Source: H-Soz-u-Kult

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September 11, 2008 13.09.2008: Ein Zweifrontenkrieg (Tageszeitung junge Welt)

Red.7 Vgl. J. Roesler, »Mit Blick auf 1968: Wirtschafts- und politische Reformen in Osteuropa«, in Z. Zeitschrift Marxistische Erneuerung, Nr. 74, Juni 2008, S. 1088 W. Ulbricht, Die Bedeutung des Werkes »Das Kapital« von Karl Marx für ...

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