Antibiotic Development to Advance Patient Treatment Act of 2013

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Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

R GingreySponsor

52 cosponsors · 25 D, 27 R

9 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of…

What it does: CRS summary · Introduced in House · Dec 12, 2013

Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.

Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.

Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Antibiotic Development to Advance Patient Treatment Act of 2013

Latest action (Dec 13, 2013): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Dec 12, 2013

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.