Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al
Filing
33
DECLARATION of Jennifer A. Sorenson in Support re: 19 MOTION for Summary Judgment.. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Exhibit U, # 22 Exhibit V, # 23 Exhibit W, # 24 Exhibit X, # 25 Exhibit Y, # 26 Exhibit Z, # 27 Exhibit AA, # 28 Exhibit BB, # 29 Exhibit CC, # 30 Exhibit DD)(Sorenson, Jennifer)
EXHIBIT P
TO DECLARATION OF
JENNIFER A. SORENSON
FDA 2009 Summary Report on Antimicrobials Sold or Distributed for Use in
Food-Producing Animals (2010)
2009
SUMMARY REPORT
on
Antimicrobials Sold or Distributed
for Use in Food-Producing
Animals
Food and Drug Administration
Department of Health and Human Services
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) (110 P.L. 316; 122
Stat. 3509) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360b) to require that sponsors of applications for new animal drugs containing an
antimicrobial active ingredient submit an annual report to the Food and Drug Administration on
the amount of each such ingredient in the drug that is sold or distributed for use in foodproducing animals, including information on any distributor-labeled product. This legislation
was enacted to assist FDA in its continuing analysis of the interactions (including drug
resistance), efficacy, and safety of antibiotics approved for use in both humans and foodproducing animals (H. Rpt. 110-804).
Each report submitted to the FDA must specify: (1) the amount of each antimicrobial active
ingredient by container size, strength, and dosage form; (2) quantities distributed domestically
and quantities exported; and (3) a listing of the target animals, indications, and production
classes that are specified on the approved label of the product. Sponsors of antimicrobial drug
products that are approved and labeled for more than one food-producing animal species are not
required to report sales and distribution information for each individual animal species. Only
total product sales information is required. The first report must be submitted not later than
March 31, 2010, and each year’s report will provide monthly sales and distribution data for the
preceding calendar year. These reports are separate from periodic drug experience reports that
are required under 21 CFR 514.80(b)(4).
Section 105 of ADUFA also directs the FDA to make annual summaries of the reported
information publicly available. In accordance with statutory requirements designed to protect
confidential business information, annual sales and distribution data will be summarized by drug
class and only those antimicrobial classes with three or more distinct sponsors of approved and
actively marketed animal drug products are independently reported. Antimicrobial classes with
fewer than three distinct sponsors are reported collectively as “Not Independently Reported”
(NIR) if the product was marketed domestically or “Not Independently Reported Export” (NIRE)
if the product was exported. The number of distinct sponsors in a particular antimicrobial class
is determined by two criteria: (1) the sponsor must be named in 21 CFR 510.600 as the holder of
an approved application for an animal drug product in that particular class on the last day of the
annual reporting period, and (2) the sponsor must have actively sold or distributed such animal
drug product at some point during that annual reporting period.
FDA’s annual summary report for 2009 is presented in Table 1. The annual totals provided in
Table 1 reflect all approved uses of all dosage forms (e.g., injectable, oral, medicated feed) of the
identified classes of actively marketed drugs in food-producing animals. Table 2 lists the 17
antimicrobial drug classes represented in the report. As reference, this table also lists the specific
drugs in each class for which there are approved animal drug products. However, the fact that an
animal drug product is approved does not necessarily mean that it was actively marketed during
this particular annual reporting period. This summary report includes antimicrobial drugs that
are specifically approved for antibacterial uses or are known to have antibacterial properties.
Anti-fungal and anti-viral drugs are not included in this report because, with the exception of
formalin and hydrogen peroxide water immersion products, there are currently no approved drug
products actively marketed for these purposes in food-producing animals.
Table 1. Antimicrobial Drugs Approved for Use in Food-Producing Animals:
2009 Sales and Distribution Data Reported by Drug Class
Antimicrobial
Class
Aminoglycosides
339,678
Cephalosporins
41,328
Ionophores
3,740,627
Lincosamides
115,837
Macrolides
861,985
Penicillins
610,514
Sulfas
517,873
Tetracyclines
4,611,892
NIR 2
2,227,366
Tetracyclines
515,819
NIRE 3
Domestic
Annual Totals
(kg 1 )
1,115,728
Export
1
kg = kilogram of active ingredient. Antimicrobials which were reported in International Units (IU)
(i.e., Penicillins and Polypeptides) were converted to kg.
2
NIR = Not Independently Reported. Antimicrobial classes for which there were less than three
distinct sponsors actively marketing products domestically were not independently reported.
These classes include: Aminocoumarins, Amphenicols, Diaminopyrimidines, Fluroquinolones,
Glycolipids, Pleuromutilins, Polypeptides, Quinoxalines, and Streptogramins.
3
NIRE = Not Independently Reported Export. Antimicrobial Classes for which there were less
than three distinct sponsors exporting products were not independently reported. These classes
include: Aminocoumarins, Aminoglycosides, Amphenicols, Cephalosporins, Diaminopyrimidines,
Fluroquinolones, Glycolipids, Ionophores, Lincosamides, Macrolides, Penicillins, Pleuromutilins,
Polypeptides, Quinoxalines, Streptogramins and Sulfas.
Table 2. Antimicrobial Drugs and Drug Classes Approved for Use in FoodProducing Animals
Aminocoumarins
Macrolides
Novobiocin
Aminoglycosides
Apramycin
Dihydostreptomycin
Efrotomycin
Gentamicin
Hygromycin B
Neomycin
Spectinomycin
Streptomycin
Carbomycin
Erythromycin
Oleandomycin
Tilmicosin
Tulathromycin
Tylosin
Penicillins
Amphenicols
Florfenicol
Amoxicillin
Ampicillin
Cloxacillin
Hetacillin
Penicillin
Pleuromutilins
Cephalosporins
Tiamulin
Ceftiofur
Cephapirin
Polypeptides
Diaminopyrimidines
Ormetoprim
Bacitracin
Polymixin B
Quinoxalines
Fluoroquinolones
Carbadox
Danofloxacin
Enrofloxacin
Streptogramins
Virginiamycin
Glycolipids
Bambermycin
Ionophores
Laidlomycin
Lasalocid
Monensin
Narasin
Salinomycin
Semduramicin
Lincosamides
Lincomycin
Pirlimycin
Sulfas
Sulfachlorpyridazine
Sulfadimethoxine
Sulfamerazine
Sulfamethazine
Sulfaquinoxaline
Sulfathiazole
Tetracyclines
Chlortetracycline
Oxytetracycline
Tetracycline
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