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).