S. 2300 · 109th Congress
Lower PRICED Drugs Act
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Never voted on. It didn't reach a floor vote before the 109th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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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…
What it does: CRS summary · Introduced in Senate · Feb 16, 2006
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 drugs to only those new drugs for which the Secretary of Health and Human Services approves labeling that contains specific, therapeutically meaningful information about the use of the drug product in pediatric patients.
Prohibits the Secretary from delaying the approval of a new drug application while a petition is reviewed and considered. Requires the Secretary to take final agency action on a petition within six months 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Lower PRICED Drugs Act
Also known as: Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act
Latest action (Feb 27, 2006): Star Print ordered on the bill.
Policy area: Health · Origin: Senate · Introduced: Feb 16, 2006
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.