New draft guidance from the Food and Drug Administration (FDA) is a step in the right direction but doesn’t go far enough to limit the non-judicious use of antibiotics in food animals, IDSA told the agency in an August comment letter. Citing the clear link between antibiotic use on the farm and antibiotic-resistant infections in people, the Society called for FDA to issue regulations to eliminate non-judicious antibiotic uses and ensure that all remaining uses come under the direct supervision of a veterinarian.
IDSA argued that regulations, rather than the voluntary draft guidance FDA has proposed, will be more effective and expedite the timetable for ending non-judicious antibiotic uses on the farm. Regulations will also provide the leverage FDA needs to enforce the agency’s new public health approach for addressing this issue. FDA’s approach calls for phasing out the use of antimicrobials for growth promotion and feed efficiency and limiting other uses of these drugs in animal agriculture, so they are carried out under the supervision of a veterinarian and within the context of a valid veterinarian-client-patient relationship.
To download a PDF of IDSA’s letter, click here. For more information about FDA’s draft guidance, see FDA’s press release.
Other IDSA advocacy efforts include:
- The Society suggested changes to the National Institute of Allergy and Infectious Diseases (NIAID) clinical trials infrastructure, in an August letter (PDF) to NIAID Director Anthony Fauci, MD, FIDSA. IDSA provided input on the future structure and objectives of clinical trial networks, including IDSA’s belief that an infrastructure addressing high-priority, life-threatening infections—similar to the National Cancer Institute’s (NCI) clinical trials network, which encompasses a spectrum of cancers—is urgently needed.
- IDSA recently shared input on the possible role of FDA in clinical trial networks and clinical trial designs for new antimicrobial agents with Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. In a letter (PDF) following up on Dr. Woodcock’s Aug. 4 teleconference with IDSA leaders, the Society also provided input on acute bacterial skin and skin structure infections (ABSSSI) and the design of clinical trials for new antibiotics to treat these infections.
- More than 40 physician groups, including IDSA, called for privacy and security safeguards for patient information that are practical, flexible, and affordable for health care providers. In a letter (PDF) earlier this month to Department of Health and Human Services Secretary Kathleen Sebelius, the groups commented on proposed changes to Health Insurance Portability and Accountability Act (HIPAA) rules, also calling for rules that minimally impact the flow of necessary health information.
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