Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 59

DECLARATION of Mitchell S. Bernard in Support re: 56 MOTION for Summary Judgment on Plaintiffs Third Claim for Relief.. 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)(Bernard, Mitchell)

EXHIBIT B
TO THE DECLARATION OF MITCHELL S. BERNARD

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DEPARTMENT OF HEALTH & HUMAN SERVICES

NOV 7 2011

Food and Drug Administration
Rockville MD 20857

Andrew Maguire
Vice President, Environmental Health
Environmental Defense
1875 Connecticut Avenue, NW
Suite 600
Washington, DC 20009
Re: Original Docket No. 05P-0139/CP
New Docket No. FDA-2005-P-0007
Dear Mr. Maguire:
This is the final response from the Food and Drug Administration ("FDA" or the
"Agency") to Citizen Petition (Original Docket No. 05P-0139/CP; New Docket No.
FDA-2005-P-0007) submitted on April 7, 2005, on behalf of Environmental Defense, the
American Academy of Pediatrics, the American Public Health Association, Food Animal
Concerns Trust, and the Union of Concerned Scientists.
The petition requests that FDA withdraw approvals for herdwide/flockwide uses of the
following antimicrobial drugs in chickens, 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 sulfonamides. Your petition seeks withdrawal of these drugs based, in
part, on the criteria listed in FDA’s Guidance for Industry #152, "Evaluating the Safety of
Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on
Bacteria of Human Health Concern" (GFI #152).
On October 4, 2005, FDA’s Center for Veterinary Medicine ("CVM" or "Center") issued
a tentative response to this Citizen Petition explaining that a final response granting or
denying the petition would not be issued until FDA makes a decision about whether to
withdraw the drug approvals listed in the petition. In that letter, the Agency also
acknowledged "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."
We have reviewed the issues raised in your petition. Although we share your concern
about the use of medically important antimicrobial drugs in food-producing animals for
growth promotion and feed efficiency indications (i.e., production uses), in accordance
with 21 CFR 10.30(e)(1)(ii), FDA is denying your petition. The reasons for this decision
are discussed below.

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In order to withdraw a new animal drug’s approval, FDA must follow a number of
statutory requirements, such as providing the sponsor of the new animal drug with notice
that the Agency proposes to withdraw approval of the drug and an opportunity for a
formal evidentiary hearing on the matter. FDA cannot withdraw approval of a new
animal drug until the legally-mandated process is complete.
Prior to initiating formal proceedings to withdraw approval of a new animal drug, CVM
makes a determination about whether such action is warranted after analyzing the
relevant data and information. The Center’s determination about whether to initiate
action to withdraw approval of a new animal drug is primarily an internal process,
although participation by drug sponsors and the public may be requested. This process
may include, among other things, an in-depth review and evaluation of available data and
information related to the particular drug, collection of additional data if needed, and in
some instances a risk assessment. This process will be used to determine whether
statutory grounds may exist to support a withdrawal action. If the Center concludes that
grounds exist to withdraw a new animal drug approval, before moving forward to
withdraw under section 512(e) of the FD&C Act, FDA must provide the drug’s sponsor
with notice and an opportunity for a formal administrative hearing ("NOOH").
Issuance of NOOHs and requests for a hearing are governed by the federal regulations
dealing with formal evidentiary hearings. A sponsor who requests a formal hearing is
required to submit detailed data to justify the request. The sponsor’s request and
supporting documentation will be reviewed and, if the Commissioner determines that a
hearing is justified, the Commissioner will issue a notice of hearing. If the Commissioner
grants a hearing, a formal evidentiary hearing is held. Generally, the Commissioner will
appoint a presiding officer to conduct the hearing and render an initial decision, which
can be appealed to the Commissioner. An order withdrawing the approval of a new
animal drug will issue only after this process is completed and the Commissioner has
found that the cited grounds for withdrawing the drug have been demonstrated. To date,
no hearings have been held with respect to the animal drugs at issue in the Citizen
Petition, and the Commissioner has not made any final determination about whether
grounds for withdrawal under section 512(e) of the FD&C Act have been satisfied.’
DISCUSSION
As discussed below, for various reasons the Agency has decided not to institute formal
withdrawal proceedings at this time and instead is currently pursuing other alternatives to
address the issue of antimicrobial resistance related to the production use of
antimicrobials in animal agriculture.
The Agency’s experience with contested, formal withdrawal proceedings is that the
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Although the Agency did publish two Notices for Opportunity for a Hearing in 1977 on proposals to
withdraw approvals of the new animal drug applications for all uses of penicillin and some uses of
tetracyclines in animal feed, no hearings were held on these proposals and no final findings were made by
the Commissioner.

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process can consume extensive periods of time and Agency resources. For example, the
first NOOHs for withdrawal of nitrofuran approvals were issued in 1971, but the final
rule withdrawing the approvals was not issued until 1991. Withdrawal of
diethylstilbestrol (DES) approvals became final in 1979, seven years after issuance of an
NOOH. More recently, the withdrawal of approved uses of erirofloxacin in poultry took
almost five years and cost FDA approximately $3.3 million.
Recognizing that the process of reviewing safety information for antimicrobial drugs
approved before 2003, and pursuing withdrawal proceedings in some cases, would take
many years and would impose significant resource demands on the Agency, in June
2010, FDA proposed a different strategy to promote the judicious use of medically
important antimicrobials in food-producing animals in a draft guidance entitled, "The
Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals"
draft Guidance for Industry #209 ("draft GFI #209"). Generally speaking, judicious uses
would be those uses that are appropriate and necessary to maintaining the health of
humans and animals.
Draft GFI #209 proposes two principles aimed at ensuring the judicious use of medically
important antimicrobials in food-producing animals. The first principle set out in the
draft guidance is that the use of medically important antimicrobial drugs in foodproducing animals should be limited to those uses that are considered necessary for
assuring animal health. As set out in the draft guidance, FDA does not consider
production uses of such drugs to be necessary for assuring animal health because, unlike
other uses, production uses are not directed at any specifically identified disease but
rather are expressly indicated and used for the purpose of enhancing the production of
animal-derived products (e.g., promoting faster weight gain or improving feed
efficiency). The second principle set out in the draft guidance is that the use of medically
important antimicrobial drugs in food-producing animals should be limited to those uses
that include veterinary oversight or consultation. This principle speaks to the need for the
scientific and clinical training of licensed veterinarians in assuring that medically
important antimicrobials are used in a judicious manner.
Based on feedback this Agency has received following the issuance of draft GFI #209,
FDA believes that the animal pharmaceutical industry is generally responsive to the
prospect of working cooperatively with the Agency to implement the principles
recommended in draft GFI #209. FDA intends to work with sponsors who approach
FDA and are interested in working cooperatively with the Agency to phase out
production uses of medically important antimicrobials and to transition medically
important antimicrobials currently approved for over the counter use in food-producing
animals to a marketing status that involves veterinary oversight (i.e., veterinary feed
directive ("VFD") status for feed use drugs and prescription status for drugs approved for
use through other routes of administration).
As part of the proposed strategy, FDA issued an advance notice of proposed rulemaking
("ANPRM") in March 2010 to seek public comment on whether and to what extent
efficiency improvements should be made to the current VFD process as set forth in
FDA’s regulation at 21 CFR 558.6. FDA received numerous public comments in

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response to the ANPRM and is taking those comments into consideration in drafting a
revised rule.
FDA believes that the strategy set out in draft guidance #209 is a pathway to achieving
the same goals as those advocated by your organization, i.e., judicious use of medicallyimportant antimicrobials. Additionally, given the considerable amount of Agency
resources that are required to pursue withdrawal proceedings, we believe the current
proposed approach will accomplish these goals in a more timely and resource-efficient
manner than would otherwise be the case. Moreover, this strategy does not foreclose
initiating withdrawal proceedings in the future.
CONCLUSION
For the foregoing reasons, FDA denies your petition. FDA is committed to working with
animal drug sponsors, the veterinary and public health communities, the animal
agriculture community, and all other interested stakeholders in developing a strategy to
address antimicrobial resistance concerns in a manner that is protective of both human
and animal health.
Sincere

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Lesli Kux
Acting Assistant Commissioner for Policy