US Congress House Bill 2629 (Prior Session Legislation)

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Sponsorship: Bipartisan Bill
Status: Introduced on June 3 2015 - 25% progression, died in committee
Action: 2015-06-05 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Antibiotic Development to Advance Patient Treatment Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication. A medication approved for use in a limited population must be labeled accordingly. The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.) The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.) Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate. The FDA may allow marketing of medical devices that use these criteria without premarket approval.

Antibiotic Development to Advance Patient Treatment Act

Rep. John Shimkus [R-IL]

Rep. Gene Green [D-TX]

Date	Chamber	Action
2015-06-05	House	Referred to the Subcommittee on Health.
2015-06-03	House	Referred to the House Committee on Energy and Commerce.
2015-06-03	House	Introduced in House

HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/2629/all-info
Text	https://www.congress.gov/114/bills/hr2629/BILLS-114hr2629ih.pdf