3.0.0 1088 2023-01-11T19:41:57Z 2023-01-11T19:41:57Z Senate S S 2007-04-11 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-04-11T19:11:50Z 2007-04-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2007-04-11 Introduced in Senate IntroReferral 10000 9 Library of Congress S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI N L000447 Sen. Lott, Trent [R-MS] CHESTER LOTT R MS TRENT 2007-04-11 True K000305 Sen. Kohl, Herb [D-WI] HERBERT KOHL D WI H. 2007-04-12 False L000261 Sen. Levin, Carl [D-MI] CARL LEVIN D MI MILTON 2007-04-16 False Health Administrative remedies Antibiotics Child health Clinical trials Commerce Consumer education Department of Health and Human Services Drug approvals Drug industry Drug utilization Families Generic drugs Government Operations and Politics Intellectual property Labeling Law Marketing Patent infringement Patents Prescription pricing Health 00 2007-04-11 Introduced in Senate 2007-07-13T20:57:49Z 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.

]]> Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes. Introduced in Senate IS Display Title Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act Short Titles as Introduced Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act Short Titles as Introduced Lower PRICED Drugs Act Introduced in Senate 2007-04-11T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s1088is/xml/BILLS-110s1088is.xml 2007-04-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.