HR 6022 · 109th Congress · Health

Lower PRICED Drugs Act

Introduced 2006-07-28· Sponsored by Rep. Waxman, Henry A. [D-CA-30]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2006-08-01)

Plain Language Summary

[AI summary unavailable — showing source text] 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. Sets forth provisions governing petitions seeking any action relating to the approval of certain new drug or abbreviated new d…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (3)

2 Democrats1 Republican