Feedstuffs
June 28, 2010
The Food & Drug Administration released a draft guidance document this [Monday] morning laying out new policy goals for the use of antimicrobials in livestock production.
FDA deputy commissioner Dr. Joshua Sharfstein told reporters that the documents lay out three key principles FDA will use in developing future strategies to prevent antimicrobial resistance. He said the principles could include potential regulations as well as voluntary actions by the industry.
Today's draft guidance outlines FDA's current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture, according to an FDA statement.
Sharfstein explained the three principles in the draft guidance are:
* Non-therapeutic use of antimicrobials, or sub-therapeutic use for feed efficiency, "is an injudicious use." The agency goal is to protect antibiotics that important to human health.
* "Medically important antimicrobial drugs" should be limited "to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation."
* Hazards of antimicrobial resistance, including the growing emergence of multiple-drug resistance is "a major public health issue."
Sharfstein said, "We don't expect anyone to change their practices today." However, he added, the draft guidance clearly indicates where the agency is headed as it considers new policy options. He said he viewed the use of antimicrobials in animal agriculture as a matter of "some urgency." He did not rule out a regulatory process, but indicated the agency is looking a numerous avenues to address the issue.
The draft guidance includes a 60-day public comment period. Dr. Bernadette Dunham, director of FDA's Center for Veterinary Medicine, predicted that after FDA reviews those comments, there would be public workshops and publication of another FDA document. She indicated that there would be collaboration with the livestock industry, veterinary profession and pharmaceutical companies.
The draft guidance as well as a fact sheet are available online at http://www.fda.gov/.
[http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf ]
Source: http://tinyurl.com/22lxzej
See Also:
Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability
Federal Register: June 29, 2010 (Volume 75, Number 124)
Notices
Page 37450-37451
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2010-D-0094
Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance (209) entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.'' This draft guidance is intended to inform the public of FDA's current thinking on the use of medically important antimicrobial drugs in food-producing animals.
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 30, 2010.
Full text:
http://edocket.access.gpo.gov/2010/2010-15289.htm
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