3.0.0 6022 2023-01-12T17:52:32Z 2023-01-12T17:52:32Z House H HR 2006-07-28 109 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2006-08-01T20:55:10Z Referred to 2006-07-28T14:15:25Z Lower PRICED Drugs Act 109 2300 S 2006-02-27 Star Print ordered on the bill. Related bill CRS 2006-08-01 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2006-07-28 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2006-07-28 Introduced in House IntroReferral Intro-H 9 Library of Congress 2006-07-28 Introduced in House IntroReferral 1000 9 Library of Congress W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 N P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2006-07-28 True D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2006-07-28 True P000583 Rep. Paul, Ron [R-TX-14] RON PAUL R TX 14 2006-11-09 False Health Administrative remedies Antibiotics Child health Civil actions and liability Clinical trials Commerce Congressional reporting requirements Consumer education Department of Health and Human Services Discovery (Law) Drug approvals Drug industry Drug utilization Drugs Evidence (Law) Families Generic drugs Government Operations and Politics Government publicity Injunctions Intellectual property Labeling Law Marketing Patent infringement Patents Pharmaceutical research Prescription pricing Public health Science, Technology, Communications Health 00 2006-07-28 Introduced in House 2006-10-05T13:50:58Z 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 drug applications, including the delay of such approval. Allows the Secretary to approve a petition to delay approval only when necessary to protect the public health. 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 PRICED Drugs Act Display Title Lower PRICED Drugs Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes. Introduced in House IH Short Titles as Introduced Lower PRICED Drugs Act Short Titles as Introduced Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act Introduced in House 2006-07-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109hr6022ih/xml/BILLS-109hr6022ih.xml 2006-08-01 Referred to the Subcommittee on Health. 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.