S.1088 - 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. view all titles (3)

All Bill Titles

  • Short: Lower PRICED Drugs Act as introduced.
  • Short: Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act as introduced.
  • Official: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes. as introduced.

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Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
04/11/07
 
 
 
 
 
 
 

Official Summary

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 include

Official Summary

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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