Generated Summary
This document is a summary report from the Food and Drug Administration (FDA) on antimicrobials sold or distributed for use in food-producing animals in 2009. It is based on data reported by sponsors of approved animal drug applications as required by the Animal Drug User Fee Amendments of 2008 (ADUFA). The report summarizes sales and distribution data by antimicrobial drug class, medical importance, and route of administration, among other categories. The report aims to provide information to the public while protecting confidential business information. The data presented are not indicative of how these antimicrobial drugs were actually used in animals. Certain limitations exist on how the data may be interpreted and used. The report excludes antifungal, antiviral, and antiprotozoal drugs without antibacterial properties. Data are summarized by antimicrobial drug class, and only those classes and other categories with three or more distinct sponsors are independently reported. The report also notes differences in the circumstances in which antimicrobial drugs are used in human and veterinary medicine that must be considered when comparing data.
Key Findings & Statistics
- In 2009, there were 25 sponsors of 157 approved new animal drug applications for antimicrobials actively marketed for use in food-producing animals (Table 1, Figure 1a, and Figure 1b).
- In 2009, sales and distribution (domestic and export) of antimicrobials approved for use in food-producing animals was approximately 12.8 million kilograms.
- Domestic sales and distribution of antimicrobials approved for use in food-producing animals were approximately 12.6 million kilograms (approximately 98%), and export sales were approximately 202.5 thousand kilograms (approximately 2%) (Table 2 and Figure 2).
- Tetracyclines accounted for 42% and ionophores for 30% of domestic sales.
- Tetracyclines accounted for 10%, sulfonamides for 7%, and penicillins for less than 1% of export sales.
- Domestic sales and distribution of antimicrobials that are not currently medically important (NCMI) accounted for 39% of the domestic sales of all antimicrobials approved for use in food-producing animals; 76% of these were ionophores (Table 3 and Figure 3).
- In 2009, domestic sales and distribution of NCMI antimicrobials approved for use in food-producing animals administered in feed accounted for 99% of the domestic sales of all NCMI antimicrobials for use in food-producing animals (Table 4 and Figure 4).
- In 2009, domestic sales and distribution of NCMI antimicrobials that are approved for use in food-producing animals and are labeled solely for production indications or for both production and therapeutic indications accounted for 73% of the domestic sales of all NCMI antimicrobials approved for use in food-producing animals (Table 5 and Figure 5).
- In 2009, domestic sales and distribution of NCMI antimicrobials that are approved for use in food-producing animals labeled with an OTC dispensing status accounted for 39% of the domestic sales of all antimicrobials for use in food-producing animals (100% of NCMI antimicrobials that are approved for use in food-producing animals) (Table 6 and Figure 6).
- In 2009, domestic sales and distribution of medically important antimicrobials accounted for 61% of the domestic sales of all antimicrobials approved for use in food-producing animals. Of these sales, tetracyclines accounted for 68%, penicillins for 9%, macrolides for 7%, sulfonamides for 7%, aminoglycosides for 3%, lincosamides for 1%, and cephalosporins for less than 1% (Table 3 and Figure 3).
- Distribution of medically important antimicrobials approved for use in food-producing animals administered in feed accounted for 74% of the domestic sales of all medically important antimicrobials for use in food-producing animals, products administered by water for 19%, by means of injection for 5%, oral or topical administration for 2%, and intramammary administration for less than 1% (Table 4 and Figure 4).
- In 2009, domestic sales and distribution of medically important antimicrobials that are approved for use in food-producing animals and are labeled solely for production indications or for both production and therapeutic indications accounted for 72% of the domestic sales of all medically important antimicrobials approved for use in food-producing animals (Table 5 and Figure 5).
- In 2009, domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals labeled with solely an OTC dispensing status accounted for 98% of the domestic sales of all medically important antimicrobials for use in food-producing animals (Table 6 and Figure 6).
- In 2009, tetracyclines administered by feed accounted for 60% of domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals, sulfas for less than 1%, and all other medically important antimicrobials for 13%. In 2009, tetracyclines administered by water accounted for 7% of domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals, penicillins for 6%, sulfas for 3%, aminoglycosides for 2%, lincosamides for less than 1%, and all other medically important antimicrobials for less than 1%. In 2009, sulfonamides administered by all other routes of administration accounted for 2% of domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals, tetracyclines for 1%, cephalosporins for less than 1%, and all other drugs for 4% (Table 7 and Figure 7).
Other Important Findings
- The report provides data on the total annual domestic sales and distribution of antimicrobial drugs approved for use in food-producing animals categorized by: (1) importance in human medical therapy; and (2) antimicrobial drug class. (Table 3 and Figure 3)
- The report provides data on the total annual domestic sales and distribution of antimicrobial drugs approved for use in food-producing animals categorized by: (1) importance in human medical therapy; and (2) route of administration. (Table 4 and Figure 4)
- The report provides data on the total annual domestic sales and distribution of antimicrobial drugs approved for use in food-producing animals categorized by: (1) importance in human medical therapy; and (2) approved label indications. (Table 5 and Figure 5)
- The report provides data on the total annual domestic sales and distribution of antimicrobial drugs approved for use in food-producing animals categorized by: (1) importance in human medical therapy; and (2) dispensing status (i.e., prescription, OTC, or VFD). (Table 6 and Figure 6)
- The report provides total annual domestic sales and distribution data of antimicrobial drugs approved for use in food-producing animals categorized by: (1) importance in human medical therapy; (2) route of administration; and (3) antimicrobial drug class. (Table 7 and Figure 7)
- Some antimicrobial drug applications include approved products that are labeled for use in both food-producing animal species (e.g., cattle and swine) and nonfood-producing animal species (e.g., dogs and cats).
Limitations Noted in the Document
- The sales and distribution data submitted by animal drug sponsors and summarized in this report are not indicative of how these antimicrobial drugs were actually used in animals (e.g., in what species and for what indications).
- The report does not provide a breakdown of sales by individual target animal species.
- The report does not include information indicating what proportion of antimicrobial drugs was sold for use in food-producing animals and what proportion was sold for use in nonfood-producing animals.
- Any yearly variations in categories presented may make it difficult to directly compare certain tabular data between reported years.
- Minor variations in tabular data may occur over time depending on when this summary data are generated, due to updates or corrections to previously submitted data from animal drug sponsors.
- FDA cannot provide sales and distribution data separately for products administered orally and topically; therefore, products approved for oral or topical means of administration have been combined into a single category.
- FDA cannot provide sales and distribution data for products labeled with VFD dispensing status; therefore, products labeled with either a VFD dispensing status or Rx dispensing status are combined into a single category.
- Because of confidentiality constraints, export sales and distribution data for antimicrobials approved for use in food-producing animals cannot be further reported.
- Because of confidentiality constraints, sales and distribution data for other drug classes of NCMI antimicrobials approved for use in food-producing animals cannot be further reported.
- Because of confidentiality constraints, FDA cannot provide sales and distribution data for products labeled solely for production indications.
- Because of confidentiality constraints, sales and distribution data for NCMI antimicrobials approved for use in food-producing animals cannot be broken out by route of administration and drug class.
- Because of confidentiality constraints, sales and distribution data for other drug classes of medically important antimicrobials approved for use in food-producing animals cannot be further reported.
Conclusion
The FDA’s 2009 summary report on antimicrobials in food-producing animals provides a comprehensive overview of sales and distribution data, categorized by drug class, medical importance, route of administration, and other factors. The report highlights the significant role of antimicrobials in animal agriculture while acknowledging the need to balance public health concerns with the protection of confidential business information. The document emphasizes that the presented data does not reflect actual drug usage in animals, and therefore, a direct comparison between human and animal drug sales is difficult. The data reveals that tetracyclines and ionophores are the most prevalent antimicrobials used in food-producing animals. The report also reveals that a large percentage of antimicrobials are administered through feed, and a significant portion of drugs are labeled for production indications, or both production and therapeutic indications. A key takeaway is that the use of medically important antimicrobials requires careful consideration. The report acknowledges the limitations regarding data reporting, including the inability to provide species-specific sales data or separate sales data for products with VFD dispensing status. The report highlights a key trend of decreasing amounts of antimicrobials are being sold for use in food-producing animals. The insights offer a window into how these drugs are distributed and used, supporting the agency’s continued monitoring of antimicrobial resistance, and the need for judicious use to protect both animal and human health. This summary underlines the ongoing efforts to manage antimicrobial use in the context of both animal and human health, offering a detailed snapshot of the landscape of antimicrobial use within food-producing animals.