s 8 42806 1176264000 false 1176264000 1088 452 110 300093

4/11/2007--Introduced.<br/>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.<br/>

1176264000 2007-04-11 Fri Nov 07 14:34:44 -0600 2008 introduced 42806 'act':4 'drug':3 'lower':1 'price':2 49810 short introduced 42806 'act':12 'drug':11 'lower':1 'price':2 'reduc':3 'effici':8 'develop':9 'increas':5 'competit':6 49811 short introduced 42806 'act':11 'bill':2 'drug':8,19 'food':7 'amend':4 'feder':6 'cosmet':10 'exclus':16 'market':15 'purpos':23 'certain':18 'respect':13 45572 official introduced 42806 1176264000 Wed Apr 11 00:00:00 -0500 2007 108229 S000770 1950-04-29 528 133 Hart Senate Office Building http://stabenow.senate.gov/email.htm 202-228-0325 Debbie Ann 'd':5 'mi':6 'ann':3,8,11 'sen':1 'debbi':2,7,10 'stabenow':4,9,12 F 300093 Stabenow Debbie_Stabenow Sen. Debbie Ann Stabenow [D, MI] 29 N00004118 14811 Democrat 202-224-4822 United Methodist MI Debbie Ann Stabenow 2.65079365079365 http://stabenow.senate.gov/ SenatorStabenow K000305 1935-02-07 2421 330 Hart Senate Office Building http://kohl.senate.gov/contact.cfm 202-224-9787 Herbert 'd':4 'wi':5 'sen':1 'herb':8 'kohl':3,7,10 'herbert':2,6,9 M 300061 Kohl Herb_Kohl H. Sen. Herbert Kohl [D, WI] 1250 Herb N00004309 10116 Democrat 202-224-5653 Jewish WI Herb Herbert Kohl 2.83333333333333 http://kohl.senate.gov/ L000261 1934-06-28 12687 269 Russell Senate Office Building http://levin.senate.gov/contact/ 202-224-1388 Carl 'd':4 'mi':5 'sen':1 'carl':2,6,8 'levin':3,7,9 M 300066 Levin Carl_Levin Sen. Carl Levin [D, MI] 7066 N00001691 26089 Democrat 202-224-6221 Jewish MI Carl Levin 2.01515151515152 http://levin.senate.gov/ L000447 1941-10-09 3862 Trent 'lott':2,4,6 'trent':1,3,5 M 300069 Lott Trent_Lott Trent Lott 1837 N00003329 4084 Republican Baptist Trent Lott SenatorLincoln introduced 42806 1176264000 Wed Apr 11 00:00:00 -0500 2007 108229 action 42806 1176264000 Wed Apr 11 00:00:00 -0500 2007 108230 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.