Under the FDCA, Congress has comprehensively regulated
animal drugs. The black market for these animal drugs includes both
foreign-made drugs that do not comply with FDCA requirements, and drugs banned
in the United States. Targets in these investigations include smugglers,
distributors to veterinarians and livestock owners, and veterinarians who
compound such drugs from smuggled raw or bulk ingredients.
The FDCA's regulation of animal drugs has two central aims.
One is to ensure that veterinary drugs are both safe and effective for the
animals that receive them, because unsafe or ineffective drugs may result in
unnecessary economic loss to livestock owners. The other aim is to insure the
safety of the nation's food supply. Unapproved animal drugs, or drugs that are
used in an unapproved manner, may leave dangerous chemical residues in food
derived from treated animals. Such residues pose serious health risks to humans
that ingest them.
The FDCA is structured to achieve its aims through two
complementary approaches. One approach is to require that all "new animal
drugs," 21 U.S.C. § 321(v), be approved as safe and effective by FDA
before being marketed for use. 21 U.S.C. § 360b. Virtually all drugs intended
for animal use are new animal drugs within the FDCA's definition and thus are
required to receive FDA's approval prior to marketing. A drug lacking such
approval is deemed to be adulterated under the FDCA and may not be distributed
in interstate commerce. 21 U.S.C. §§ 331, 351(a)(5), 360b. The other approach
is to require that all drugs be properly labeled so that all users, including
laymen, can use them safely and effectively. 21 U.S.C. § 352. A drug that is
not properly labeled is deemed to be misbranded and may not be distributed in
interstate commerce. 21 U.S.C. §§ 331, 352.
FDA grants pre-market approval to a "new animal
drug" only if its sponsor succeeds in demonstrating that the drug is safe
and effective for its intended uses. To gain approval, the sponsor must submit
a "new animal drug application" ("NADA") bearing extensive,
scientifically rigorous data covering a number of subjects. Such subjects
include the ingredients and composition of the drug; the methods and controls
used in producing the drug; and the extent to which foods derived from animals
treated with the drug may contain chemical residues that pose health risks to
humans. 21 U.S.C. § 360b(b)(1). More specifically, a NADA must describe how the
manufacturer proposes to measure chemical residues in food products derived
from treated animals and must describe any restrictions on use of the drug
necessary to keep such residues at safe levels.
Approval of an NADA, if granted, pertains only to those
particular uses of the drug specified in the application (uses that would
typically be confined to particular animals). 21 U.S.C. § 360b(a)(1). For
instance, an NADA showing safety and effectiveness of a particular formulation
for a disease condition in swine does not allow the manufacturer to claim
similar effectiveness for the disease condition in cattle. Due to the metabolic
differences in species of animals, each new condition must be the subject of an
approval. Moreover, FDA can revoke approval if, at a later time, evidence
demonstrates that a drug is not safe or effective for the particular uses for
which it has been approved. 21 U.S.C. § 360b(e).
quoted from here
Black Market
The extensive research, as well as laboratory and field
testing, that is necessary to establish safety and efficacy is expensive. Drugs
that are claimed to be the same as an approved drug, except for the fact they
have been made by a different manufacturer, must still meet the rigorous NADA
procedures. This requirement exists because it has been established that drugs,
even though they may be of a similar chemical composition, do not necessarily
work the same way. Drugs which have not been approved by FDA may be cheaper to
obtain because they do not bear the overhead associated with the approval
process. However, the use of a drug that lacks approval is accompanied by the
very real threat that the drug may be harmful to the animal to which it is
given, may not be effective, and/or may leave harmful residues in the animal's
meat, milk or eggs.
In addition to the premarket approval requirements for new
animal drugs, the FDCA requires that all drugs, including veterinary drugs, be
properly labeled so as to assure their safe and effective use. This means that
all veterinary drugs must have adequate directions which instruct users,
including laymen, on numerous matters such as how to dispense the drug for the
appropriate conditions and in the proper manner, dose, frequency, and duration.
Without such directions, the use of a drug could result in the drug not being
effective or, even worse, harmful. A drug that is not properly labeled is
misbranded. 21 U.S.C. § 352.
Investigations into the black market distribution of
unapproved drugs intended for use in food producing animals have revealed that
individuals and companies buy, at discount prices, foreign-made drugs that do
not comply with the requirements of the FDCA, and then have the drugs smuggled
or otherwise illegally imported into the United States. They are then sold
either as contraband, i.e., as available supplies of animal drugs widely
understood to be subject to a flat prohibition on use, or as "generic equivalents"
of, or substitutes for, approved animal drugs.
In other words, the animal drug black market reflects two
types of economic incentives. One type of incentive is the substantial profit
to be made in simply bypassing FDA's pre-market approval process. In response
to this first kind of incentive, black marketeers sell substitutes (supposedly
chemical equivalents) for established, approved drugs. Typically, the
substitutes contain active ingredients smuggled or otherwise unlawfully
imported into this country from abroad. Not having been subjected to FDA
scrutiny, and not having been compounded or formulated for use under conditions
meeting the high standards of pharmaceutical science, the illegal substitutes
are not assured of having the same composition, purity, effectiveness, and
safety as the approved formulations they purport to replace. This is true even
though the approved formulations and illegal analogues may share active
ingredients or possess the same or similar chemical composition. The illegal
products are, however, marketed at much lower prices than the approved drugs.
The second type of economic incentive is the large profit to
be made in bringing to market drugs that are effective in treating
food-producing animals but that have been banned by FDA because of health risks
to humans or for some other reason. In response to this second type of
incentive, black marketeers again typically smuggle into the United States or
otherwise unlawfully import drug substances, active ingredients in bulk, from
abroad.
The FDCA's prohibitions on the distribution in
interstate commerce of misbranded or adulterated animal drugs reach quite far
across the chain of distribution. For example, since the FDCA defines
"drug" to include any article intended for use as a component of a
"drug", 21 U.S.C. § 321(g)(1)(D), bulk ingredients destined for
inclusion in any new animal drug are deemed to be adulterated and misbranded
unless specifically within the coverage of an approved NADA governing all
aspects of the new animal drug, including identity of ingredients. 21 U.S.C. §§
351(a)(5), 360b. Likewise, the term "new animal drug" includes
pharmaceutical ingredients intended for use in an animal feed. 21 U.S.C. §
321(w)quoted from here
Black Market
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"Black-markets" exist for several types of drugs
that lead to prosecutions under the Food, Drug, and Cosmetic Act (FDCA).
These include new drugs that are not yet controlled substances, performance
enhancing drugs, and animal drugs that are distributed outside FDA regulated
channels. The issues that arise in these cases differ from issues in
Controlled Substances Act cases. "Buy-bust" scenarios in these
areas also raise concerns in addition to those under the Controlled
Substances Act.
A.
Manufacturers
and Distributors of Gamma Hydroxy Butyrate (GHB)
Manufacturers and distributors of the body-building and
psychoactive drug gamma hydroxy butyrate, or "GHB", operate
clandestinely. See this manual at 16 for a description of
circumstances in which FDCA violations take place, 17 for sample charges, and 18 for portions of a probation letter.
B.
Human
Growth Hormone
Distributing anabolic steroids or human growth hormone for
muscle enhancement is unlawful. Incuded is a description of the evolution of
relevant statutes, stating which are currently effective. This section should
be consulted before attempting any prosecution involving human growth hormone
or anabolic steroids, the latter of which are now controlled substances.
Particular care must be used in prosecuting drug-dealing physicians who
dispense human growth hormone. See this manual at 19.
C.
The
"Buy-Bust" Prosecution
FDCA cases involving sales of illicit drugs are vastly
different from Controlled Substances Act cases. Mere possession of FDA
regulated drugs is not generally unlawful. Additional elements of fraudulent
intent, interstate commerce, the nature and identity of the product, and
"adulteration" or "misbranding" must be established.
Rarely, if ever, is a "buy-bust" advisable unless considerable
investigation has been conducted. A more detailed discussion of these issues
is included in this manual at 20.
D.
Animal
Drug Prosecutions
OCL coordinates investigations into the black market
distribution of unapproved drugs intended for use in food producing animals.
See this manual at 21 for a general description of
the pertinent regulatory framework, 22 and 23 for sample indictments, and 24
and 25 for jury instructions. See this manual at 26 et seq. for a trial
memorandum describing issues that may arise. See this manual at 28 for a memorandum regarding
expert testimony, frequently required in such cases, and 29re applying the "intent to defraud
FDA" felony theory to an animal drug prosecution.
[cited in USAM 4-8.220]
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