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Prescription Drug Importation
In the context of rising drug prices, the possibility of
importing prescription drugs from other countries at lower
prices is again being debated. Generally, the importation or
reimportation of a prescription drug that does not meet
Food and Drug Administration (FDA) requirements is
prohibited. The policy debate has centered on creating a
legal option for the import of lower-cost prescription drugs
into the United States.
Prescripton Drug Regulation
FDA, under the Federal Food, Drug, and Cosmetic Act
(FFDCA), regulates prescription drugs. In order to market a
new drug in the United States, a manufacturer must obtain
approval from FDA by submitting a new drug application
(NDA), or in the case of a generic drug, an abbreviated
NDA (ANDA). To get approval, the manufacturer must (1)
demonstrate the drug's safety and effectiveness according
to criteria specified in law and regulation, (2) ensure that its
manufacturing facility passes FDA inspection, and (3)
obtain approval for the drug's labeling. Drugs made in
foreign countries that are imported into the United States
for commercial distribution must comply with the same
FFDCA requirements as domestically manufactured drugs,
including registration and premarket approval. A drug
manufacturer may import drugs produced abroad that have
not yet received approval (e.g., drugs intended for further
processing) by complying with FDA and U.S. Customs and
Border Protection (CBP) requirements. See CRS Report
R41983, How FDA Approves Drugs and Regulates Their
Safety and Effectiveness, and CRS Report R46507, FDA 's
Role in the Medical Product Supply Chain and
Considerations During COVID-19.
Prescription Drug Importation
Foreign-made versions of FDA-approved drugs that have
not been evaluated through the FDA process are typically
considered unapproved new drugs and are illegal. The
FFDCA provides for the circumstances under which an
unapproved drug may be imported into the United States.
This section discusses the circumstances under which
importation is prohibited, as well as the circumstances
under which it is allowed.
Importation That Is Prohibited Under Current Law
Under current law, the importation of unapproved new
drugs, including foreign-made versions of FDA-approved
drugs, is generally prohibited. This would entail bringing
into the United States an unapproved drug manufactured
outside of the United States. Even in cases where the drug
is a foreign-made version of an FDA-approved drug (i.e.,
the same active ingredient made by the same manufacturer),
FDA has stated that it is highly unlikely that the version for
the foreign market would meet all of the requirements in the
FFDCA for approval. Current law prohibits the introduction
Updated January 22, 2024
into interstate commerce of a drug that is unapproved,
adulterated (e.g., held under insanitary conditions), or
misbranded (e.g., the labeling does not include adequate
directions for use) [FFDCA Sections 505(a), 301(a), (d)].
Commercial Use. FFDCA Section 801(d)(1)(B) explicitly
prohibits the importation for commercial use of unapproved
drugs manufactured outside of the United States, with two
exceptions: (1) as authorized by the Secretary of Health and
Human Services (HHS) pursuant to a drug shortage, and (2)
pursuant to the authority at FFDCA Section 804 (discussed
in the next section). This prohibition does not apply to
drugs when, although manufactured outside of the United
States, the manufacturer has authorized them to be
marketed in the United States and has labeled them
according to relevant FFDCA requirements.
Reimportation. Current law also prohibits the
reimportation-importing an exported U.S.-manufactured
drug back into the United States-of a U.S.-manufactured
drug by anyone other than the manufacturer (FFDCA
Section 801(d)(1)(A)). Reimportation of a U.S.-
manufactured drug by anyone other than the original
manufacturer is illegal even if it meets all of the
requirements for approval under the FFDCA because it
could have been mishandled or otherwise adulterated when
it was outside of the reach of FDA. FFDCA Section
801(d)(2) creates an exception to this prohibition, allowing
the HHS Secretary to authorize the reimportation of a U.S.-
manufactured drug where required for emergency medical
care, or under FFDCA Section 804, as described below.
The provision prohibiting the reimportation of U.S.-
manufactured drugs was put in place in 1987 in an effort to
ensure a closed system for all prescription drugs
marketed in the United States. Proponents of this
prohibition argued that it protected against the possibility of
prescription drugs that were manufactured in the United
States and then exported from being brought onto the
American market in possibly subpotent, mislabeled,
adulterated, expired, or counterfeit form. Manufacturer
reimportation was permitted to allow for standard inventory
control practices within the industry.
Importation That Is Allowed Under Current Law
FFDCA Section 804. Section 804 gives the HHS Secretary
authority to promulgate regulations to establish a drug
importation program under which pharmacists and
wholesalers could import unapproved prescription drugs
from Canada into the United States, with certain
qualifications. Specifically, the provision provides that the
program cannot become effective until the HHS Secretary
certifies that the importation program would pose no
additional risk to the public's health and safety and would
offer significant reduction in the cost to U.S. consumers.
Until recently, no Secretary had given such approval.](ViewImageLocal?handle=hein.crs/goveobr0001&div=1&collection=&method=preview&ext=.png&size=3)