August 01, 2010

 

 FDA seeks comments on draft antimicrobial use guide, feed directive process

Document addresses judicious use, antimicrobial resistance

posted July 18, 2010
 

A draft federal guidance document advocates for eliminating some antimicrobial uses and increasing veterinarian involvement in the use of antimicrobials in feed.

The Food and Drug Administration published on June 28 a draft guidance document indicating that medically important antimicrobials—defined as those important for therapeutic use in humans—should be used in food-producing animals only when necessary to ensure animal health and that veterinarians should provide oversight or consultation prior to use of such antimicrobials in feed. The FDA is accepting comments on the document.

"Because antimicrobial drug use contributes to the emergence of drug resistant organisms, these important drugs must be used judiciously in both animal and human medicine to slow the development of resistance," the document states.

Dr. Bill T. Flynn, senior adviser for science policy for the FDA Center for Veterinary Medicine, said that the document focuses on drugs important for human medical treatment and that the agency is concerned about the use of such drugs in food animals when it is not connected with management of disease and does not involve veterinary oversight.

The concern does not extend to the use of drugs such as ionophores that have no application in human medicine, he said.

The FDA is interested in all available approaches to implementing the changes in antimicrobial use, including voluntary means through work with pharmaceutical companies, food animal producers, and veterinary organizations, Dr. Flynn said.

"We're hopeful that we can get engagement and work collaboratively with these groups to implement these changes in a way that ensures that animal health needs continue to be addressed and we minimize the disruption and impacts on the ag industry," Dr. Flynn said.

The AVMA Policy "Judicious Therapeutic Use of Antimicrobials" states that "veterinarians should strive to optimize therapeutic efficiency and minimize resistance to antimicrobials to protect public and animal health." The Policy "Antimicrobials in Livestock Feeds" states that the AVMA recognizes the importance of antimicrobials used in human medicine and supports rigorous science-based evaluation to determine the appropriate use of such antimicrobials in animals.

The FDA document states that veterinarians should be involved in decisions regarding antimicrobial use, whether they are diagnosing diseases and administering treatments or consulting with producers to establish disease management protocols.

At press time, the AVMA House of Delegates was scheduled to vote on whether to consider two resolutions addressing antimicrobial use during its 2010 regular annual session July 29-30. One states that veterinarians should be involved in the decision-making process for the use of antimicrobials in animals, and the other that the AVMA should be at the forefront of discussions affecting availability of drugs, especially antimicrobials.

Dr. James D. McKean, chair of the AVMA Food Safety Advisory Committee and a professor at the Iowa State University College of Veterinary Medicine, said he understands the FDA's position but suggests that scientific studies have not made as clear a connection between antimicrobial resistance in humans and antimicrobial use in animals as is indicated in the document. He thinks food producers and veterinarians would be much more amenable to discontinuing the use of low concentrations of antimicrobials in feed if that connection were to become clear.

Dr. McKean said weaning pigs, for example, generally have improved health when fed low concentrations of antimicrobials in their feed, but the guidance document would classify this as use for growth promotion or feed efficiency because it is not aimed at a specific disease.

The FDA document states that veterinarians should be involved in decisions regarding antimicrobial use, whether they are diagnosing diseases and administering treatments or consulting with producers to establish disease management protocols.

The AVMA Policy "Judicious Therapeutic Use of Antimicrobials" also indicates that therapeutic use of prescription antimicrobials should meet all requirements of a veterinarian-client-patient relationship and that veterinarians should work with those responsible for the care of animals to use antimicrobials judiciously, regardless of how the drugs were obtained.

The changes in antimicrobial use proposed by the draft guidance document are indirectly connected to the FDA's call for comments on the veterinary feed directive process, Dr. Flynn said. The agency has been seeking comments on the regulation, which is related to the distribution and use of medicated feeds under veterinary supervision.

Few feed-use antimicrobials have been approved under the regulation, and their use requires supervision by a veterinarian and a valid veterinarian-client-patient relationship.

A March 29 Federal Register notice opening the call for comments stated that the FDA had received feedback that the VFD process is burdensome. Recently the agency extended the deadline for comments through Aug. 27. Dr. Flynn said that, because the FDA wants to move toward greater veterinarian oversight for use of some antimicrobials, the agency needs a process that can facilitate that oversight.

The FDA is seeking comments on the antimicrobial draft guidance through Aug. 30. To view the guidance document or to comment, go to www.regulations.gov and search for "FDA-2010-D-0094." Written comments can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

To submit comments on the VFD process, go to www.regulations.gov and search for "FDA-2010-N-0155." Written comments can be sent to the same address as comments on the antimicrobial draft guidance.