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 L
TO DECLARATION OF
JENNIFER A. SORENSON
FDA Tentative Response to 2005 Petition (2005)

DEPARTMENT

OF HEALTH

& HUMAN

SERVICES

Food and Drug Administration
Rockville MD 20857

OdJoL7, & -7 Ag
:47
. Karen Florini, Senior Attorney
Environmental Defense
1875 Connecticut Avenue, NW
Suite 600
Washington, DC 20009
Re: Docket No. 05P-0139
Dear Ms. Florini:
Pursuant to the administrative regulations at 21 CFR 10.30(e)(2)(iii), this is a tentative
response to the Citizen Petition (05P-0139/CP 1) submitted by you on behalf of
Environmental Defense, the American Academy of Pediatrics, the American Public
Health Association, and the Union of Concerned Scientists.
The petition requests that FDA withdraw approvals for herdwide/flockwide uses of the
following antimicrobial drugs in chicken, swine, and beef cattle for purposes of growth
promotion (including weight gain and feed efficiency) and disease prevention and control
(except for non-routine use where a bacterial infection has been diagnosed within a herd
or flock): penicillins., tetracyclines, aminoglycosides, streptogramins, macrolides,
lincomycin, and sulfc)namides.
Your petition seeks withdrawal of these drugs based, in part, on the criteria listed in
Guidance for Industry #152, “Evaluating the Safety of Antimicrobial New Animal Drugs
with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.”
Guidance # 152 outlines a qualitative risk assessment approach to evaluate the microbial
food safety of certain drugs.
In order for the Agency to withdraw a new animal drug approval, two processes need to
be completed. First, FDA’ Center for Veterinary Medicine (Center or CVM) needs to
s
determine whether to initiate formal withdrawal proceedings. Second, if the Center
decides to initiate formal withdrawal proceedings, it must then undertake the formal
withdrawal process required by statute. For legal, scientific and resource reasons,
withdrawal actions for the petitioned drugs need to be considered on a drug by drug basis.
Data and information will need to be reviewed and analyzed for each drug. Thus, the
petitions can only be granted or denied on a drug by drug basis as reviews are completed
and resources permit.
An approved new animal drug application can be withdrawn if, among other things,
experience or scientific data show that the drug is unsafe (section 512(e)(l)(A)), or if the
drug is not shown to be safe (section 5 12(e)(l)(B)). If the Center concludes that a drug’
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Page 2 - Docket 05P-0139
approval should be withdrawn, it is required by section 5 12(e)(l) to provide the drug’
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sponsor with notice and an opportunity for a formal administrative hearing (NOOH). A
separate NOOH is orldinarily issued for each individual drug, because most of the
relevant scientific evidence is likely to be unique to the individual drug, although actions
involving chemically related drugs may be consolidated.’
Issuance of NOOHs and requests for a hearing are governed by the FDA’ regulations
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regarding formal evidentiary public hearings (2 1 CFR Parts 12 and 5 14). A sponsor who
requests a formal hearing is required to submit detailed data to justify the request. The
request will be reviewed and, if the Commissioner determines that a hearing is justified, the
Commissioner will issue a notice of hearing. A presiding officer will conduct a formal
evidentiary hearing and render an initial decision, which can be appealed to the
Commissioner. A sponsor may appeal the Commissioner’ decision to withdraw an
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approval of a new animal drug to the U.S. Court of Appeals as specified in section 512(h).
The Agency’ experience with contested, formal withdrawal proceedings is that the
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process can consume extensive periods of time and Agency resources. For example, the
NOOH for withdrawal1 of the approval for enrofloxacin in poultry was issued in October
20002, but the final rule withdrawing the approval was not published until August 2005,
with an effective date of September 12, 2005.3
The Agency recognizes the need to address concerns related to the role that antimicrobial
drug use in food-producing animals plays in the emergence and selection of antimicrobial
drug resistant bacteria.. To address these public health concerns, the FDA has developed
a regulatory strategy that includes Guidance #I52 which describes a recommended
process for evaluating, the safety of antimicrobial drugs intended for use in foodproducing animals. Guidance #152 is based on the Agency’ current thinking on this
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topic and is primarily aimed at providing guidance to sponsors of antimicrobial new
animal drug applications on evaluating the safety of their proposed product during the
pre-approval process. As stated in Guidance #152, it contains non-binding
recommendations. Like all FDA guidance documents, Guidance #152 does not establish
legally enforceable responsibilities.

’ For example, separate NOOHs were issued for the proposed wthdrawals of approval for nitrokazone
(36 FR 5927, March 31, 1971) and fiu-azolidone (36 FR 14343, August 4, 1971), but the actions involving
both nitrofurans were consolidated for hearing. See 56 FR 4 1902 (August 23,199l).
* See 65 FR 64954 (October 3 1,200O)
3 See 70 FR 44048 (August 1,2005)

Page 3 - Docket OSP-0139
As explained above, the petition can only be granted or denied when the Agency makes a
final decision on whether to withdraw any of the drug approvals listed in your petition.
Therefore, at this time, it would be premature to grant or deny the petition, in whole or in
part.
Sincerely yours,
J

h-J/#

Stephen F. Sun&f, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

cc: HFA-305 (Docket 05P-0139)