US HB3742 | 2013-2014 | 113th Congress
Status
Spectrum: Bipartisan Bill
Status: Introduced on December 12 2013 - 25% progression, died in committee
Action: 2013-12-13 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on December 12 2013 - 25% progression, died in committee
Action: 2013-12-13 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
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 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.
Title
Antibiotic Development to Advance Patient Treatment Act of 2013
Sponsors
History
| Date | Chamber | Action |
|---|---|---|
| 2013-12-13 | House | Referred to the Subcommittee on Health. |
| 2013-12-12 | House | Referred to the House Committee on Energy and Commerce. |
Subjects
Administrative law and regulatory procedures
Administrative remedies
Consumer affairs
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Government information and archives
Health
Health information and medical records
Infectious and parasitic diseases
Licensing and registrations
Medical research
Prescription drugs
Administrative remedies
Consumer affairs
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Government information and archives
Health
Health information and medical records
Infectious and parasitic diseases
Licensing and registrations
Medical research
Prescription drugs
US Congress State Sources
| Type | Source |
|---|---|
| Summary | https://www.congress.gov/bill/113th-congress/house-bill/3742/all-info |
| Text | https://www.congress.gov/113/bills/hr3742/BILLS-113hr3742ih.pdf |
