3.0.0 185 2023-01-11T13:28:52Z 2023-01-11T13:28:52Z Senate S 2015-01-16 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2016-04-18T22:31:47Z Markup by 2016-04-06T14:00:00Z Referred to 2015-01-16T17:31:27Z 2016-04-18 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 425. Calendars 2016-04-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2016-04-18 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2016-04-06 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2015-01-16 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-01-16 Introduced in Senate IntroReferral 10000 9 Library of Congress H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT N B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2015-01-16 True A000368 Sen. Ayotte, Kelly [R-NH] Kelly Ayotte R NH 2015-02-03 False I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA 2015-02-25 False K000360 Sen. Kirk, Mark Steven [R-IL] MARK KIRK R IL STEVEN 2015-04-29 False C000174 Sen. Carper, Thomas R. [D-DE] Thomas Carper D DE R. 2015-07-21 False B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2016-04-07 False 2016-08-09T20:55:00Z S. 185, Promise for Antibiotics and Therapeutics for Health Act https://www.cbo.gov/publication/51887 As reported by the Senate Committee on Health, Education, Labor, and Pensions on April 18, 2016 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 2015-01-16 Introduced in Senate 2015-04-10T21:20:03Z Promise for Antibiotics and Therapeutics for Health Act or the PATH Act

Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to approve as a limited population antibacterial drug an antibacterial drug intended to treat a serious medical condition and to address an unmet medical need within an identifiable limited population.

Requires the FDA's determination of the safety and effectiveness of these drugs to reflect the drug's benefit-risk profile in the intended limited population. Prohibits the FDA from denying approval of a drug based on a lack of evidence of a favorable benefit-risk profile in a broader population.

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

Requires the FDA to conduct post-approval monitoring programs to study how these antibacterial drugs are used and to monitor changes in bacterial drug resistance.

Allows the FDA to remove the labeling, marketing, and post-approval monitoring requirements of these drugs if they are approved for broader use.

Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.]]> 01 2016-04-18 Reported to Senate with amendment(s) 2017-01-04T15:46:33Z Promise for Antibiotics and Therapeutics for Health Act or the PATH Act

(Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to encourage the health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service to report on antibacterial drug use, bacterial resistance to antibacterial drugs, and antibiotic stewardship programs.

HHS must: (1) annually publish information on antibacterial resistance and antibiotic stewardship; (2) disseminate guidance and materials regarding antibiotic stewardship; (3) continue working with state and local public health departments on antibacterial resistance programs; and (4) collect, evaluate, and publish data from the antibiotic stewardship activities of health care facilities.

(Sec. 3) This bill amends the Federal Food, Drug, and Cosmetic Act to permit the Food and Drug Administration (FDA), at the request of the drug sponsor, to approve an antibiotic drug for use in a limited population if the drug is intended to treat a serious infection in a limited population of patients with unmet medical needs. The FDA must issue guidance on demonstrating the safety and effectiveness of such drugs. The FDA's determination of the safety and effectiveness of such a drug must reflect the drug's use in the intended limited population.

The label and prescribing information of such a drug must indicate that the drug has been approved for use only in a limited population. The sponsor of such a drug must submit promotional materials for the drug to the FDA prior to dissemination. The FDA may remove these requirements for such a drug that is approved for broader use.

The FDA must report the number of requests for approval and the number of approvals of such drugs. The Government Accountability Office must report on activities to combat antimicrobial resistance and the limited population drug approval process established by this bill.]]> 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 Reported to Senate PATH Act S Senate Short Titles as Introduced Promise for Antibiotics and Therapeutics for Health Act Short Titles as Introduced PATH Act Short Titles as Reported to Senate Promise for Antibiotics and Therapeutics for Health Act S Senate Reported to Senate 2016-04-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s185rs/xml/BILLS-114s185rs.xml Introduced in Senate 2015-01-16T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s185is/xml/BILLS-114s185is.xml 2016-04-18 Placed on Senate Legislative Calendar under General Orders. Calendar No. 425. 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.