[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79383-79385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31889]



[[Page 79383]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0528]


Unapproved Animal Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency) is 
soliciting comments from stakeholders on strategies to address the 
prevalence of animal drug products marketed in the United States 
without approval or other legal marketing status. FDA is concerned that 
the safety and effectiveness of these actively-marketed products has 
not been demonstrated. Therefore, the Agency is requesting comments on 
approaches for increasing the number of legally-marketed animal drug 
products, as well as on the use of enforcement discretion for some 
unapproved animal drug products in certain limited circumstances.

DATES: Submit either electronic or written comments by February 18, 
2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tracey H. Forfa, Center for Veterinary 
Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-9000. e-mail: <a href="/cdn-cgi/l/email-protection#4d393f2c2e2834632b223f2b2c0d2b292c6325253e632a223b"><span class="__cf_email__" data-cfemail="f0848291939589de969f829691b0969491de989883de979f86">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Purpose

    FDA is soliciting comments from all stakeholders, including the 
regulated industry, veterinary professionals, and the public on 
strategies to address the prevalence of animal drug products marketed 
in the United States without approval or other legal marketing status. 
The Agency is concerned that the safety and effectiveness of these 
marketed products has not been demonstrated. FDA recognizes that the 
continued availability of a number of these products is important to 
meet the health needs of animals. FDA is requesting comments on 
approaches for increasing the number of currently marketed animal drug 
products that have legal marketing status. Our focus at this time is 
not on revising the current new animal drug approval process. Instead, 
we wish to explore additional mechanisms that utilize FDA's existing 
regulatory framework as well as novel strategies not currently employed 
by the agency to increase the number of approved or otherwise legally 
marketed animal drugs. Furthermore, we are requesting comment on the 
use of limited enforcement discretion as an element of the overall 
strategy.

II. Background

    New animal drugs cannot be legally marketed unless they have been 
reviewed and approved, conditionally approved, or index-listed by FDA. 
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) defines the 
term ``drug'' to include articles intended for use in the diagnosis, 
cure, mitigation, treatment, or prevention of disease in man or other 
animals, and articles (other than food) intended to affect the 
structure or any function of the body of man or other animals (section 
201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). The FD&C Act also 
defines the term ``new animal drug.'' A ``new animal drug'' includes 
any drug intended for use for animals that is not generally recognized 
as safe and effective for use under the conditions listed in the drug's 
labeling (section 201(v) of the FD&C Act).
    Under the FD&C Act, a new animal drug may not be legally introduced 
into interstate commerce unless it is the subject of an approved new 
animal drug application (NADA) or abbreviated new animal drug 
application (ANADA) under section 512 of the FD&C Act (21 U.S.C. 360b), 
a conditional approval (CNADA) under section 571 of the FD&C Act (21 
U.S.C. 360ccc), an index listing under section 572 of the FD&C Act (21 
U.S.C. 360ccc-1), or an investigational new animal drug exemption 
(INAD) under section 512(j) of the FD&C Act (21 U.S.C. 360b(j)). When 
this notice refers to an ``unapproved animal drug,'' we mean an animal 
drug that does not have a necessary approval, conditional approval, 
index listing, or INAD exemption.
    The FD&C Act's new animal drug approval requirements provide 
important protection for humans and animals. Animal drugs that are 
marketed without required FDA review and approval may not meet 
requirements and standards for, among other things, safety and 
effectiveness. The FDA drug approval process ensures, through an 
evaluation of scientific evidence, that animal drugs are safe and 
effective. The approval process also provides a review of product-
specific information that is critical to ensuring the safety and 
effectiveness of the finished animal drug product. For instance, the 
sponsor of an NADA must demonstrate that the manufacturing processes 
can reliably produce drug products of expected identity, strength, 
quality, and purity. Furthermore, FDA's review of the applicant's 
labeling assures that veterinarians, animal owners and other consumers 
have the information necessary to understand a drug product's risks. In 
addition, firms marketing approved animal drug products must report 
adverse events associated with their product's use, which helps FDA 
continuously assess the risks associated with a particular product. 
Although the conditional approval and indexing requirements differ in 
some ways from the animal drug approval process, they all provide for a 
science-based review to assure the drug will be safe for its intended 
use. FDA employs these standards in the new animal drug approval 
process to protect both human and animal health.
    For many years, FDA has been aware that a wide variety of animal 
drug products are being marketed that meet the definition of ``drug'' 
and ``new animal drug'' as defined in the FD&C Act, but are not 
approved, conditionally approved, or indexed. Many of these unapproved 
animal drugs were, and some continue to be, the standard of care in 
treating animals, and some are essential to protecting animal health 
and ensuring an adequate food supply.
    In general, the types of unapproved animal drugs being marketed 
include, but are not limited to, injectable vitamins, various topical 
solutions, shampoos, and liniments, electrolyte and glucose solutions, 
and antidotes. In addition, there are a variety of anti-infective and 
other animal drug products marketed for use in a variety of animal 
species. The Agency determined, based on available information, that 
some of these animal drug products or categories of products did not 
raise safety concerns. With respect to those products, the Agency 
historically exercised its enforcement discretion, even though such 
products lacked the required FDA marketing approval. This approach has 
been important for setting enforcement priorities and for making 
decisions as to whether to take action against an illegally marketed 
unapproved drug or class of drugs under particular circumstances.
    Some of these unapproved drugs which did not raise safety concerns 
have been marketed under an FDA letter of ``no objection,'' issued in 
response to a firm's request, stating that FDA did not at the time 
object to the marketing of a particular unapproved new animal

[[Page 79384]]

drug. In addition, some unapproved drugs have been marketed under the 
auspices of Compliance Policy Guides issued by FDA to let its staff, 
the public, and industry know the conditions under which FDA would 
consider enforcement action with respect to these unapproved drugs. 
This practice of proactively announcing the Agency's intent to exercise 
enforcement discretion with respect to particular types of unapproved 
drugs under specified conditions has been used in certain circumstances 
because of the relatively limited number of approved animal drugs 
available to meet the animal health needs of a diverse number of animal 
species.
    FDA recognizes that it will be necessary to continue to exercise 
enforcement discretion in limited circumstances for certain essential 
unapproved animal drug products or categories of products as the Agency 
works to develop new ways to increase the availability of products that 
are approved or otherwise legally marketed. However, it is the Agency's 
general expectation that new animal drugs must be approved or otherwise 
legally marketed as required by the FD&C Act. Therefore, any exercise 
of the Agency's enforcement discretion with respect to unapproved 
animal drugs should be limited to the greatest extent possible. To that 
end, the Agency is seeking comment on strategies for increasing the 
number of animal drug products that are legally marketed, and thus 
decreasing the number of currently marketed products that lack approval 
or other legal marketing status. Such strategies may include 
alternative pathways to achieve legal marketing status that assure 
animal drug products meet safety and effectiveness standards, including 
human food safety standards. However, even after alternative pathways 
to legal marketing are established, some drugs may not be well-suited 
to such alternatives and may be required to go through the new animal 
drug approval process, especially in cases where there are safety or 
effectiveness concerns. For example, certain drug products intended for 
use in food-producing animals may only be able to achieve legal 
marketing status through the traditional new animal drug approval 
process because of concerns about drug residues appearing in edible 
tissues.

III. Agency Request for Comments

    FDA is soliciting public comment on potential actions the Agency 
can take to help achieve the goal of obtaining legal marketing status, 
as appropriate, for unapproved animal drugs that are currently being 
marketed in the United States. We are interested in comments on 
strategies that utilize FDA's existing regulatory framework for 
addressing this issue as well as comments on novel strategies not 
currently employed by the Agency. In conjunction with pursuing this 
goal, the Agency recognizes the need for maintaining the availability 
of essential animal drugs for pet owners, veterinarians, and animal 
producers.
    FDA is also specifically requesting comments and information on the 
questions and subjects below. This list is not all-inclusive, however, 
and is not intended to limit the range of options available for public 
comment. The Agency asks that comments be as detailed as possible, with 
explanations and information to assist FDA in evaluating whether the 
approaches will help accomplish the goal of increasing the number of 
currently marketed animal drug products that have approval or other 
legal marketing status. FDA's intent is that of inquiry and not for 
anyone to read this list as any indication of the Agency's position on 
a particular approach or a determination that the Agency has the 
resources to implement such an approach.

A. Increasing the Availability of Legally Marketed Animal Drug Products

    In general, the types of unapproved animal drugs being marketed 
include, but are not limited to: Injectable vitamins; various topical 
solutions, shampoos, and liniments; electrolyte and glucose solutions; 
and antidotes. In addition, there are a variety of anti-infective and 
other animal drug products marketed for use in a variety of animal 
species. Given the broad array of animal drug products that are 
important for meeting the health needs of a diverse number of animal 
species, FDA is interested in exploring alternative approaches (i.e., 
alternatives to the existing new animal drug approval process) by which 
those products could be legally marketed. Some examples of alternative 
approaches are discussed in sections III.A.1 and III.A.2 of this 
document.
1. Monographs
    Certain over-the-counter (OTC) drugs for humans are marketed under 
monographs that establish the conditions under which these drugs are 
generally recognized as safe and effective and not misbranded. The 
monographs specify active ingredients, dosage forms, product strengths, 
indications for use, labeling, and other conditions. Human OTC drug 
products that comply with all of a monograph's conditions and the 
provisions in 21 CFR part 330 may be manufactured and distributed 
without applications or any other premarket review. Monographs are 
developed after review of available information about safety and 
effectiveness, including published and unpublished data and information 
submitted to the Agency, and must be supported by adequate and well-
controlled studies.
    Does published literature of sufficient quality exist for some 
currently marketed unapproved animal drugs such that monographs might 
be a feasible approach? For which drugs might this be feasible? What 
are the attributes that make the published literature suitable for this 
purpose? What criteria should be used to determine whether an animal 
drug is potentially suitable for a monograph to ensure that quality, 
safety and effectiveness would not be compromised in the absence of 
premarket review?
2. Use of Publicly Available Information
    In some cases, human prescription drugs have been approved and 
marketed after FDA reviewed the existing literature and data regarding 
a particular drug or class of drugs. Examples of drugs for which FDA 
has used this approach include the following:
    <bullet> Prussian Blue (see ``Guidance for Industry on Prussian 
Blue for Treatment of Internal Contamination With Thallium or 
Radioactive Cesium; Availability'' (68 FR 5645, February 4, 2003)) and
    <bullet> Pancreatic Enzymes (see ``Exocrine Pancreatic 
Insufficiency Drug Products'' (69 FR 23410, April 28, 2004), ``Exocrine 
Pancreatic Insufficiency Drug Products for Over-the-Counter Human Use'' 
(56 FR 32282, July 15, 1991), and ``Guidance for Industry: Exocrine 
Pancreatic Insufficiency Drug Products--Submitting NDAs,'' issued in 
April 2006 and available online at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071651.pdf).
    For each of these drugs, FDA reviewed the publicly available 
information and published in the Federal Register a discussion 
regarding the drug's safety and effectiveness, and any conclusions 
reached by the Agency based on that review. Firms then submitted drug 
applications referencing the public information and/or the Federal 
Register notice to address certain information requirements needed for 
an application.
    Does published literature of sufficient quality exist for some 
animal drugs that could be used to support safety and effectiveness 
evaluations for these

[[Page 79385]]

currently unapproved marketed drugs? For which drugs might this be 
feasible? What attributes make published literature of sufficient 
quality to contribute to such an evaluation?

B. Limiting the Use of Enforcement Discretion

    As stated previously, the Agency acknowledges that the practice of 
exercising enforcement discretion in certain circumstances is necessary 
to ensure the availability of some essential animal drug products. This 
practice of exercising enforcement discretion (i.e., a decision on the 
part of the Agency to not take enforcement action in certain 
circumstances) is not only important for managing limited Agency 
resources related to compliance activities but is also important for 
assuring that certain animal drug products remain available for 
addressing the health needs of animals. However, FDA's goal is to 
limit, to the extent possible, its use of enforcement discretion for 
unapproved animal drugs.
    What factors should the Agency consider when determining which 
unapproved animal drug products or categories of products should be the 
subject of enforcement discretion?

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31889 Filed 12-17-10; 8:45 am]
BILLING CODE 4160-01-P


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