PATH Act

Bill: 114-s-185
Sponsor: Sen. Hatch, Orrin G. [R-UT]
Introduced: 2015-01-16 in the Senate
Policy area: Health
Subjects: 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)

Summary:
action_date: 2015-01-16
text: 

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.
action_date: 2016-04-18
text: 

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.

Legislative actions:
action_date: 2016-04-18
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 425.
action_date: 2016-04-18
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-04-18
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-04-06
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2015-01-16
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2015-01-16
text: Introduced in Senate