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Titles (2)

Short Titles

Short Titles - Senate

Short Titles as Introduced

Preventing Antibiotic Resistance Act of 2015

Official Titles

Official Titles - Senate

Official Titles as Introduced

A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and effectiveness of medically important antimicrobials approved for use in the prevention and control of animal diseases, in order to minimize the development of antibiotic-resistant bacteria.


Actions Overview (1)

Date
03/02/2015Introduced in Senate

All Actions (1)

Date
03/02/2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1218-1219)
Action By: Senate

Cosponsors (7)


Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
Senate Health, Education, Labor, and Pensions03/02/2015 Referred to

No related bill information was received for S.621.


Latest Summary (1)

There is one summary for S.621. View summaries

Shown Here:
Introduced in Senate (03/02/2015)

Preventing Antibiotic Resistance Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refuse a new animal drug application if the drug is a medically important antimicrobial (used to treat humans) and the applicant fails to demonstrate that the drug meets specified criteria for use in animals, including that: (1) the drug is effective, (2) the drug is targeted to animals at risk of developing a specific bacterial disease, (3) the drug has a defined duration of therapy, and (4) there is reasonable certainty of no harm to human health from microbial resistance to the drug.

Sponsors of certain medically important antimicrobials already approved for use in food-producing animals must submit evidence to the FDA that demonstrates that their drug meets the criteria described above for approved indications. The FDA must withdraw approval for any indication for which the FDA determines there is insufficient evidence that the drug meets the criteria.

This bill expresses the sense of the Senate that a veterinarian-client-patient relationship should ensure that medically important antimicrobials are used in food-producing animals in a manner consistent with best practices.