As part of its overall responsibility for ensuring the safety of animal drugs, CVM is addressing public health safety concerns associated with antimicrobial drug use in animals and the development of antimicrobial resistant bacteria. These efforts are focused on the use of antimicrobial drugs in food-producing animals and the impact of such use on antimicrobial resistance in foodborne bacterial pathogens. During FY 2011, we took steps to enhance the quality and accuracy of antimicrobial drug sales and distribution data, and to develop strategies for addressing antimicrobial resistance concerns.
On December 9, 2010, CVM published its first annual report summarizing sales and distribution data of antimicrobial drugs approved for food-producing animals. The data reported were for calendar year 2009. The Animal Drug User Fee Amendments of 2008, Section 105, requires antimicrobial drug sponsors to report the amount of antimicrobial active ingredient in their drugs that have been sold or distributed for use in food-producing animals. The Animal Drug User Fee Act also requires FDA to summarize the sales and distribution information received from drug sponsors each year, and to provide these summaries to the public.
The collection of data on antimicrobial drugs, such as the sales and distribution information, assists CVM in its evaluation of antimicrobial resistance trends as well as its analysis of other issues that may arise relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals such as cattle, swine, and poultry.
During the year we implemented enhancements to improve the quality and accuracy of data on the active antimicrobial ingredients in animal drugs, strengthening FDA’s position on the judicious use of antibiotics and limiting production use of antibiotics. CVM:
- Created a relational database for receiving 2010 food-producing animal antimicrobial data. The relational database is written in Microsoft Access, a powerful tool that allows for easy entry, access, and reporting of antimicrobial distribution data. The new database has helped save time and resources, and ensured accuracy and consistency of the reported data.
- Established a contract and implemented plans for electronic receipt of food-producing animal antimicrobial data into a newly designed corporate database.
- Issued reminder letters to drug sponsors who were seriously delinquent in their periodic annual drug experience reporting.
- Identified drug products that had not been marketed for several years as candidates for withdrawal of the approved applications.
As part of our work to address antimicrobial resistance, we continued to work on the issue of the judicious use of medically important drugs. In June 2010, FDA published draft Guidance for Industry #209, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.” The draft guidance document communicated our key recommendations on the use of these important drugs in food-producing animals. Judicious use is vital to minimizing antimicrobial resistance while still maintaining the availability of these drugs for assuring the health of animals.
During FY 2011, we completed a review and analysis of the public comments submitted on draft Guidance for Industry #209. We continued a dialogue with all interested stakeholders, to discuss our recommendations and to hear their thoughts and concerns about implementation. Stakeholder input is critical to support the ongoing effort to develop strategies to ensure that public health is protected while also ensuring that the health needs of animals continue to be met.
One of the key recommendations in draft Guidance for Industry #209 is to limit the use of medically important antimicrobial drugs in food animals to therapeutic uses with veterinary involvement. Our current focus is on those antimicrobial drugs that are considered medically important and are currently administered to food animals through feed or water. For feed use antimicrobials, this means changing their marketing status from over-the-counter to veterinary feed directive. For water use products, this would mean changing their status from over-the-counter to prescription. These considerations were part of our discussions with all affected stakeholders during FY 2011 to develop a strategy for ensuring the judicious use of medically important antimicrobial drugs.
In 2008, FDA issued an order that would have prohibited all extralabel uses of cephalosporin drugs in food-producing animals. The goal was to preserve the effectiveness of cephalosporin drugs for treating disease in humans. However, FDA revoked the order so that it could review all comments received during the public comment period. Based on our review of the comments, we have developed a revised order that prohibits those specific extralabel uses that present a risk to public health. (The order was published in FY 2012.)
Scientists from CVM and FDA’s Center for Drug Evaluation and Research continued to collaborate in the biomarkers topic area of the Medical Counter Measures Initiative regulatory science program for Chemical, Biological, Radiological, and Nuclear agents and pandemic influenza. This project focuses on rapid, sensitive, and comprehensive detection of antibiotic resistant determinants in biothreat agents and in bacteria associated with disease outbreaks. The project’s long-term goal is to provide point-of-care diagnosis of antibiotic resistance as early as possible so that the appropriate individual and group treatments can be quickly tailored for the situation at hand.
The project scientists are working to develop a high density, oligonucleotide-based microarray that includes all the available antibiotic resistance genes in public and privately owned databases, including those associated with soil-dwelling bacteria. The microarray will constitute a significant improvement over current methodology, which detects fewer antibiotic resistance genes. During FY 2011, the project staff updated and installed necessary laboratory equipment, and began updating the database of antibiotic resistance gene sequences with new information that is available since the first generation array was designed.
Distiller’s grains result from the fermentation of various crops to produce ethanol. CVM is concerned about potential animal and human health hazards from the use of distiller’s byproducts as animal feed ingredients, due to the possibility that the byproducts will contain antibiotic residues. Among other consequences, the residues could lead to the development of antimicrobial-resistant organisms.
During the past year we have been developing a draft guidance document related to antibiotic residues in distillers grains used for animal feed. At the end of FY 2011, an initial draft was undergoing review within the agency.