Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years, with tremendous benefits to both human and animal health. However, the use of antimicrobial drugs in animal agriculture has garnered a significant amount of attention in recent years due to the threat bacterial resistance to antibiotics in both humans and animals poses to public health.
The U.S. Food and Drug Administration (FDA) has provided guidance on the use of antimicrobial drugs in animal agriculture for several decades. On Dec.11, 2013, FDA released Guidance for Industry #213 (GFI #213) and a Proposed Rule that would amend Veterinary Feed Directive (VFD) guidelines, each of which are examined in this article.
What is GFI #213?
Essentially, GFI #213 is non-binding guidance regarding the use of antimicrobial drugs in animal agriculture. This guidance instructs antimicrobial drug manufacturers to remove production-related claims—meaning to promote growth or increase feed efficiency—from their product labels. Instead, the manufacturers are to market these products only for their therapeutic effects—meaning to treat illness.
Notably, it is illegal under the Federal Food, Drug and Cosmetic Act (FFDCA) to use medicated feed or antimicrobial drugs for extralabel uses. Additionally, producers will be required to obtain a prescription, or VFD, from a veterinarian for antimicrobial drugs. A VFD cannot be obtained for uses not contained on the product’s label. Finally, FDA has proposed amendments to VFD guidelines to streamline the implementation of these new non-binding requirements for using antimicrobial drugs throughout the animal agriculture supply chain.
It is worth noting that lawmakers have also given attention to the issue of antimicrobial drug use in animals. In March of 2011, and again in 2013, Representative Louise Slaughter (D-NY), a microbiologist, introduced the Preservation of Antibiotics for Medical Treatment Act. The law would, among other things, amend the FFDCA to heighten the standard for approval of a new animal drug that is considered a medically important antimicrobial. The bill resides with the House Energy & Commerce Subcommittee on Health and is unlikely to receive a hearing or vote anytime soon. The purpose of the legislation is likely overtaken by this recent action by FDA as well.
Antimicrobial Drugs, Food Animals and the FDA
Antimicrobial drugs used in animal agricultural are generally regulated by the FDA. Prior to the mid-1990s, most antimicrobial drugs were approved for over-the-counter (OTC) use in food-producing animals and many of these were administered through medicated feed or drinking water. According to recent statements by the FDA, the methods used to assess the microbial food safety aspects of new animal drug applications for antimicrobials intended for use in food-producing animals were not as rigorous as those used today, in part because less scientific data about the public health ramifications of antimicrobial resistance existed at that time.