3.0.0 2996 2023-01-11T13:25:04Z 2023-01-11T13:25:04Z Senate S S 2014-12-10 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2014-12-10T21:59:42Z 2014-12-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2014-12-10 Introduced in Senate IntroReferral 10000 9 Library of Congress B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO N H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT 2014-12-10 True Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Health 00 2014-12-10 Introduced in Senate 2015-03-24T14:21:22Z Promise for Antibiotics and Therapeutics for Health Act or the PATH Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to establish a program to approve an antibacterial drug intended to treat a serious medical condition and address an unmet medical need within an identifiable limited population as a limited population antibacterial drug.

Requires the sponsor of a drug eligible for approval as a limited population antibacterial drug to demonstrate the safety and effectiveness of the drug for its intended use.

Requires an HHS determination of the safety and effectiveness of a limited population antibacterial drug to reflect the drug's benefit-risk profile in the intended limited population. Prohibits a lack of evidence of a favorable benefit-risk profile in a broader population from resulting in a denial of approval.

Directs HHS to require: (1) the labeling of a limited population antibacterial drug to indicate that the drug has been approved for use only in a limited population, and (2) submission of promotional materials related to the drug prior to dissemination.

Directs HHS to describe considerations for demonstrating the safety and effectiveness of limited population antibacterial drugs and how the limited population pathway can be expanded to other therapeutic areas.

Requires HHS to conduct postapproval monitoring programs to study how antibacterial drugs approved through the limited population pathway are used and to monitor changes in bacterial drug resistance.

Allows HHS to remove the labeling, marketing, and postapproval monitoring requirements of a limited population antibacterial drug if the drug is approved for broader use.

Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.]]> PATH Act Display Title PATH Act Official Title as Introduced A bill to create a limited population pathway for approval of certain antibacterial drugs. Introduced in Senate IS Short Titles as Introduced PATH Act Short Titles as Introduced Promise for Antibiotics and Therapeutics for Health Act Introduced in Senate 2014-12-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s2996is/xml/BILLS-113s2996is.xml 2014-12-10 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.