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 N
TO DECLARATION OF
JENNIFER A. SORENSON
FDA Letters to Drug Sponsors (2004)

Carol A. Wrenn
President, Animal Health Division
Alpharma Inc.
One Executive Drive
Fort Lee, New Jersey 07027-1298
Dear Ms. Wrenn:
As you are aware, the Center for Veterinary Medicine was charged with examining previously
approved antimicrobial products as a result of an amendment to the FY 2001 appropriations
sponsored by U.S. Representative Sherrod Brown. As part of that effort, we have completed our
review of the administrative file for your Penicillin 100 (penicillin G procaine 50, Type A
Medicated Article, NADA 046-666).
Our review included an examination of the correspondence contained in, data submitted to, and
master files referenced in, the administrative file. We conducted a qualitative risk assessment in
light of the Center's recently published Guidance for Industry #152 entitled, "Evaluating the
Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on
Bacteria of Human Health Concern," using the information contained in the records.
We are taking this opportunity to provide you with a summary of our findings:
•

The codified indications are: ""For increased rate of weight gain and improved feed
efficiency."

•

§558.15 studies were conducted in swine and chickens. Originally the company
participated in the AHI effort and sought subtherapeutic indication. Then the original
sponsor withdrew from AHI and sought therapeutic indication.

•

CVM reviewed the studies and concluded that they had met the Salmonella shedding
requirements under §558.15, but that there were still questions about the observed
increases in resistant Salmonella and E. coli. Insufficient information to address GFI
#152.

•

CVM concluded numerous times that efficacy data were insufficient for the therapeutic
claims.

•

The NADA was DESI finalized on April 10, 1998 for the subtherapeutic indications.

•

CVM's proposal to withdraw penicillin premixes remains pending. 42 FR 43,770. Aug.
30, 1977 and 42 FR 56,264, Oct. 21, 1977.

Page 2 - Ms. Wrenn
The administrative record does not contain sufficient information to alleviate the Center's concern
about the use of your product and its possible role in the emergence and dissemination of
antimicrobial resistance. We used only that information on penicillin contained in your
administrative file to evaluate your product. Where information on your specific product was
lacking, we generally took a conservative approach and assessed the risk as high. The outcome of
the qualitative risk assessment conducted according to Guidance #152 is that the product is
considered Category 1. Production claims for increased rate of weight gain and improved feed
efficiency are not considered appropriate for Category 1 or 2 products under Guidance #152.
The Center for Veterinary Medicine would like to invite you to meet with us and discuss our
findings. Please contact my office as soon as possible to arrange this. If you have any questions
please contact Dr. Linda Tollefson, Deputy Director at 301-827-2950.
Sincerely yours,

Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

cc: NADA 046-666
Director, Office of New Animal Drug Evaluation
Division Director, Human Food Safety

Carol A. Wrenn
President, Animal Health Division
Alpharma Inc.
One Executive Drive
Fort Lee, New Jersey 07027-1298
Dear Ms. Wrenn:
As you are aware, the Center for Veterinary Medicine was charged with examining previously
approved antimicrobial products as a result of an amendment to the FY 2001 appropriations
sponsored by U.S. Representative Sherrod Brown. As part of that effort, we have completed our
review of the administrative file for your Aureo S-P250® (NADA 035-688); CSPTM 250 (NADA
039-077); and –ChlorachelTM 250 (NADA 091-668).
Our review included an examination of the correspondence contained in, data submitted to, and
master files referenced in, the administrative file. We conducted a qualitative risk assessment in
light of the Center's recently published Guidance for Industry #152 entitled, "Evaluating the
Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on
Bacteria of Human Health Concern," using the information contained in the records.
We are taking this opportunity to provide you with a summary of our findings:
Aureo S-P250® (NADA 035-688)
•

The product is a Type A medicated article intended to produce a Type C medicated feed
consisting of 100 grams of chlortetracycline, 50 grams of procaine penicillin, and 100
grams of sulfamethazine per ton of feed.

•

The codified indication is: "for reduction of the incidence of cervical abscesses;
treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by
Salmonella choleraesuis and vibrionic dysentery), prevention of these diseases during
times of stress; maintenance of weight gains in the presence of atrophic rhinitis; growth
promotion and increased feed efficiency in swine weighing up to 75 pounds.

•

Protocols and data to address 21 CFR 135.109/558.15 were submitted. The requirements
of 21 CFR 558.15 were not met.

•

CVM's proposal to withdraw Aureo S-P250® remains pending. 42 FR 43,770, Aug. 30,
1977 and 42 FR 56,264, Oct. 21, 1977.

Page 2 - Ms. Wrenn
CSPTM 250 (NADA 039-077)
•

The product is a Type A medicated article intended to produce a Type C medicated feed
consisting of 100 grams of chlortetracycline, 50 grams of procaine penicillin, and 100
grams of sulfathiazole per ton of feed.

•

The codified indication is: "for reduction of the incidence of cervical abscesses;
treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella
choleraesuis and vibrionic dysentery), maintenance of weight gains in the presence of
atrophic rhinitis; swine 10 lbs of body weight to 6 weeks post weaning: increased rate of
weight gain and improved feed efficiency. Swine 6 to 16 weeks post weaning: increased
rate of weight gain." (21 CFR 558.155).

•

Protocols and data to address 21 CFR 135.109/558.15 were submitted. The requirements
of 21 CFR 558.15 were not met.

•

CVM's proposal to withdraw CSPTM 250 remains pending. 42 FR 43,770, Aug. 30, 1977
and 42 FR 56,264, Oct. 21, 1977.
ChlorachelTM 250 (NADA 091-668)

• The product is a Type A medicated article intended to produce a Type C medicated feed
consisting of 100 grams of chlortetracycline, 50 grams of penicillin and 100 grams of
sulfamethazine.
• The codified indication is: "It is administered to swine in a Type C feed for reduction of
the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or
necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of
these diseases during times of stress; maintenance of weight gains in the presence of atrophic
rhinitis; growth promotion and increased feed efficiency in swine weighing up to 75
pounds." (21 CFR 558.145).
•

Protocols and data to address 21 CFR 135.109/558.15 were submitted. The requirements
of 21 CFR 558.15 were not met.

•

CVM's proposal to withdraw ChlorachelTM 250 remains pending. 42 FR 43,770, Aug.
30, 1977 and 42 FR 56,264, Oct. 21, 1977.

The administrative record does not contain sufficient information to alleviate the Center's concern
about the use of these products and their possible role in the emergence and dissemination of
antimicrobial resistance. We used only that information on penicillin, tetracycline, sulfathiazole,
and sulfamethazine contained in your administrative files to evaluate your products. Where
information on your specific products was lacking, we generally took a

Page 3 - Ms. Wrenn
conservative approach and assessed the risk as high. The outcome of the qualitative risk
assessment conducted according to Guidance #152 is that the product is considered Category 1.
Production claims for weight gain, maintenance of weight gains in the presence of atrophic
rhinitis and for growth promotion and increased feed efficiency in swine are not considered
appropriate for Category 1 or 2 products under Guidance #152.
The Center for Veterinary Medicine would like to invite you to meet with us and discuss our
findings. Please contact my office as soon as possible to arrange this. If you have any questions
please contact Dr. Linda Tollefson, Deputy Director at 301-827-2950.
Sincerely yours,

Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

cc: NADA 035-688
NADA 039-077
NADA 091-668
Director, Office of New Animal Drug Evaluation
Division Director, Human Food Safety

Gregory P. Bergt
Director, Regulatory Affairs
Pennfield Oil Company
14040 Industrial Road
Omaha, NE 68144
Dear Mr. Bergt:
As you are aware, the Center for Veterinary Medicine was charged with examining previously
approved antimicrobial products as a result of an amendment to the FY 2001 appropriations
sponsored by U.S. Representative Sherrod Brown. As part of that effort, we have completed our
review of the administrative file for your Pennchlor SP 250 and Pennchlor SP 500 (NADA 138934).
Our review included an examination of the correspondence contained in, data submitted to, and
master files referenced in, the administrative file. We conducted a qualitative risk assessment in
light of the Center's recently published Guidance for Industry #152 entitled, "Evaluating the
Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on
Bacteria of Human Health Concern," using the information contained in the records.
We are taking this opportunity to provide you with a summary of our findings:
• Both products are Type A medicated articles intended to produce a Type C medicated
feed consisting of 100 grams of chlortetracycline, 50 grams of penicillin and 100 grams of
sulfamethazine.
• The codified indication is: "It is administered to swine in a Type C feed for reduction of
the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or
necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of
these diseases during times of stress; maintenance of weight gains in the presence of atrophic
rhinitis; growth promotion and increased feed efficiency in swine weighing up to 75
pounds." (21 CFR 558.145).
•

Protocols and data to address 21 CFR 135.109/558.15 were submitted. The requirements
of 21 CFR 558.15 were not met.

•

CVM's proposal to withdraw penicillin premixes remains pending. 42 FR 43,770, Aug.
30, 1977 and 42 FR 56,264, Oct. 21, 1977.

Page 2 - Mr. Bergt
The administrative record does not contain sufficient information to alleviate the Center's concern
about the use of your product and its possible role in the emergence and dissemination of
antimicrobial resistance. We used only that information on penicillin, tetracycline, and
sulfamethazine contained in your administrative file to evaluate your product. Where information
on your specific product was lacking, we generally took a conservative approach and assessed the
risk as high. The outcome of the qualitative risk assessment conducted according to Guidance
#152 is that the product is considered Category 1. Production claims for maintenance of weight
gains in the presence of atrophic rhinitis and for growth promotion and increased feed efficiency
are not considered appropriate for Category 1 or 2 products under Guidance #152.
The Center for Veterinary Medicine would like to invite you to meet with us and discuss our
findings. Please contact my office as soon as possible to arrange this. If you have any questions
please contact Dr. Linda Tollefson, Deputy Director at 301-827-2950.
Sincerely yours,

Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

cc: NADA 138-934
Director, Office of New Animal Drug Evaluation
Division Director, Human Food Safety

Norma A. Buckart
Manager, Regulatory Affairs
Phibro Animal Health
710 Rt. 46 East
Suite 401
Fairfield, NJ 07004
Dear Ms. Buckart:
As you are aware, the Center for Veterinary Medicine was charged with examining previously
approved antimicrobial products as a result of an amendment to the FY 2001 appropriations
sponsored by U.S. Representative Sherrod Brown. As part of that effort, we have completed our
review of the administrative file for your Penicillin G Procaine 50% (Type A Medicated Article,
NADA 46-668).
Our review included an examination of the correspondence contained in, data submitted to, and
master files referenced in, the administrative file. We conducted a qualitative risk assessment in
light of the Center's recently published Guidance for Industry #152 entitled, "Evaluating the
Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on
Bacteria of Human Health Concern," using the information contained in the records.
We are taking this opportunity to provide you with a summary of our findings:
•

The codified indications are: "For increased rate of weight gain and improved feed
efficiency."

•

No data were found to address 21 CFR 558.15 or GFI #152.

•

CVM's proposal to withdraw penicillin premixes remains pending. 42 FR 43,770, Aug.
30, 1977 and 42 FR 56,264, Oct. 21, 1977.

The administrative record does not contain sufficient information to alleviate the Center's concern
about the use of your product and its possible role in the emergence and dissemination of
antimicrobial resistance. We used only that information on penicillin contained in your
administrative file to evaluate your product. Where information on your specific product was
lacking, we generally took a conservative approach and assessed the risk as high. The outcome of
the qualitative risk assessment conducted according to Guidance #152 is that the product is
considered Category 1. Production claims for increased rate of weight gain and improved feed
efficiency are not considered appropriate for Category 1 or 2 products under Guidance #152.

Page 2 - Ms. Buckart
The Center for Veterinary Medicine would like to invite you to meet with us and discuss our
findings. Please contact my office as soon as possible to arrange this. If you have any questions
please contact Dr. Linda Tollefson, Deputy Director at 301-827-2950.
Sincerely yours,

Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

cc: NADA 046-668
Director, Office of New Animal Drug Evaluation
Division Director, Human Food Safety