HR 3742 · 113th Congress · Health

Antibiotic Development to Advance Patient Treatment Act of 2013

Introduced 2013-12-12· Sponsored by Rep. Gingrey, Phil [R-GA-11]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2013-12-13)

Plain Language Summary

[AI summary unavailable — showing source text] 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 patients for which there is an unmet medical need. 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 f…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (20)

10 Democrats10 Republicans