July 12, 2012 - ASM Comments on FDA Draft Guidance for Industry

For More Information

[Docket No. FDA–2010–D–0094]
Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability

[Docket No. FDA–2011–D–0889]
Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209; Availability

Guidance #209

Guidance #213



Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Land, Room 1061
Rockville, MD  20852

Re:  Comment on Draft Guidance for Industry #213 (Docket No. FDA-2010-N-0155 also Docket No. FDA-2011-D-0889)

To Whom It May Concern:

The American Society for Microbiology (ASM) appreciates the opportunity to comment on FDA documents published April 13, 2012, that are intended to phase out the nontherapeutic use of antimicrobial drugs in food-producing animals:

  • FDA Draft Guidance for Industry #213, New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 
  • FDA Draft Veterinary Feed Directive [Docket No. FDA-2010-N-0155] that specifies how veterinarians can authorize the use of certain drugs in animal feed 

The ASM is the largest single life science Society with approximately 38,000 members who are involved in research, education and public health and who are concerned with emerging public health threats including drug resistant pathogens. 

The ASM appreciates FDA’s ongoing commitment to address the critical problem of antimicrobial resistance.  This is a problem that is being seen in an ever expanding number of human pathogens.  There is a growing scientific body of literature demonstrating that antimicrobial resistance among many human pathogens is inextricably linked to the use of antimicrobial agents in animal populations.  Hence a comprehensive approach to control and ultimately reverse antimicrobial resistance must limit the inappropriate and non-judicious use of antimicrobial agents in veterinary medicine and food production.  

The ASM believes that the draft documents represent a significant step forward towards controlling the non-judicious use of antimicrobial agents in the veterinary sector.  They do this by transitioning new antibiotics and antibiotic combinations from over-the-counter dispensing to veterinary feed directives (VFDs) or therapeutic use requirements and by establishing processes for veterinarians to authorize the use of antibiotics in animal feed.  

The ASM recognizes that collectively these documents represent a significant shift away from over-the-counter antimicrobials used as growth promoters in animal feed toward certain medically important drugs being restricted to therapeutic uses overseen by veterinarians. 

While the ASM is generally supportive of the proposals, there are several areas of concern: 

  • The proposed guidance is voluntary.  

The ASM appreciates the complex issues involved in regulating the use of antibiotics in agricultural settings, as there are many involved stakeholders who may have competing agendas.  The proposed guidance sets a 3-month period for manufacturers to notify FDA of their intent and a 3-year period to modify labeling and indications.  At the end of that period FDA will evaluate the success of the voluntary approach.   

While this may convince the manufacturing community to adopt the FDA guidance, the ASM has concerns that if this approach is unsuccessful, three years would have elapsed before additional steps can be taken.  The ASM believes that FDA should incorporate shorter time periods for interim reviews of implementation and should disseminate information about compliance by the manufacturing community.  In addition, the ASM believes that FDA should explicitly state what steps will be taken at the end of the three year period so that stakeholders have a clear understanding of what may happen if the anticipated outcomes do not occur.

  • Preventive use of antibiotics in food animals 

The ASM understands that there are situations in the livestock industry where the risk of illness in animals is increased, and these situations can be predicted to occur.  The proposed guidance allows the preventive use of antibiotics in these situations.   However, the ASM is concerned that a greater emphasis is not placed on processes and procedures that could reduce the stress levels and risks to the animals.  The use of preventive antibiotics is not a substitute for these other risk reduction strategies, and there are studies that demonstrate these strategies can obviate the need for antibiotic administration.  The ASM would suggest that FDA incorporate stronger language to encourage these measures to be implemented so that preventive use of antibiotics can be phased out.

  • Veterinary shortage areas 

The ASM realizes that there are areas that lack ready access to veterinarians, and this may pose challenges to implementing the proposed VFD guidance.  However, ASM is opposed to any waiver of VFD requirements, and suggests that alternatives, such as the use of veterinary extenders or tele-prescribing, may be a better approach than a waiver.  

  • International preventive use needed

Because meat and fish products are imported by the United States from other countries that use antibiotics, the FDA should take the lead to get other countries to reduce antibiotics significantly as they are doing in the United States. Limiting use in this country addresses only a part of the problem of worldwide antimicrobial resistance, which is a global threat.

The ASM supports FDA’s efforts to protect the public against the overuse and misuse of antibiotics in food animal production.  The proposed changes will help address growing concerns that using drugs in animal feed for nontherapeutic purposes contributes to the rising incidence of drug-resistant microbial pathogens tied to human illnesses.  We, therefore, largely agree with the draft guidance and directive.  

The ASM has long been concerned about drug resistance among pathogens that renders current drugs ineffective, which is further complicated by the shrinking industry pipeline of novel antimicrobial drugs and other products.  We appreciate the opportunity to comment and look forward to assisting the FDA in any way possible as it addresses the issue of antimicrobial resistance. 


Jeffery F. Miller, Ph.D., President, ASM 
Roberto Kolter, Ph.D., Chair, Public and Scientific Affairs Board
Stephen M. Ostroff, M.D. Chair, Committee on Public Health
Gail H. Cassell, Ph.D., Chair, Committee on Biomedical Research