Current
Laws for Importing Drugs to the US
Rules and
Regulations
Information on
Importation of Drugs
"House OK's Easing Drug
Import Rules"
By Philip Brasher
The Associated Press
WASHINGTON (AP) - Amid growing public
resentment of high prescription drug prices, the House voted
overwhelmingly Monday to prevent the government from discouraging
the purchase of drugs in Canada or other countries.
An increasing number of Americans have been
going to Canada, Mexico and other countries to purchase prescription
drugs cheaper than what they cost in the United States.
Technically, it's illegal to import
prescription drugs that were originally made in the United States,
and the Food and Drug Administration sometimes sends warning letters
to people caught doing it. The agency gives its employees discretion
to permit imports of drugs that violate its restrictions so long as
they are intended for personal use.
The House approved, 363-12, an amendment to
an FDA appropriations bill that would prevent the agency from
enforcing the importation ban, so long as the drugs are for personal
use. A second amendment, approved 370-12, would bar the agency from
sending the warning letters. "People's lives are being shortened
today because of the abnormally high and ridiculously increased
price of prescriptions,'' said Rep. Tom Coburn, R-Okla.
Because of cost controls, drugs can cost
several times less in Canada, Mexico and Europe than in the United
States, leading some Americans to buy their pharmaceuticals by mail
order or else join bus trips across the border to fill their
prescriptions.
For example, Prilosec, a popular ulcer
medication, costs $400 for 100 capsules in New York but $184 in
Canada and $107 in Mexico, said Rep. Joseph Crowley, D-N.Y.
"Prescription drugs and medicines are not a
luxury, they are a necessity,'' added Crowley.
High drug prices have emerged as a
significant issue in this year's political campaigns. Polling
indicates the issue of prescription drugs is a priority for
Americans 65 and older, a group that accounted for more than
one-quarter of voters in the 1998 elections and is regarded as a key
swing group in the fall campaign.
Republicans pushed a bill through the House
last month that would use private insurance and federal subsidies to
cover some of the cost of prescription drugs for senior citizens.
President Clinton has threatened to veto
the legislation. He and congressional Democrats are advocating a
more encompassing but also costlier alternative: a uniform,
government-run prescription drug benefit, offered to all 39 million
elderly and disabled Medicare beneficiaries.
FDA spokesman Lawrence Bachorik said the
agency is concerned that the House legislation could undermine its
"ability to protect consumers and patients from substandard, poorly
manufactured or otherwise risky drugs.''
"The FDA stands ready to work with Congress
on these issues,'' he added.
The bill is H.R.4461.
See: Food and Drug Administration:
http://
www.fda.gov/
Prepared by the
Division of Import Operations and Policy, FDA
The United States Federal Food, Drug, and
Cosmetic Act (Act) (21 U.S.C. section 331)prohibits the interstate
shipment (which includes importation) of unapproved new drugs. Thus,
the importation of drugs that lack FDA approval, whether for
personal use or otherwise, violates the Act. Unapproved new drugs
are any drugs, including foreign-made versions of U.S. approved
drugs, that have not been manufactured in accordance with and
pursuant to an FDA approval. Under the Act, FDA may refuse admission
to any drug that "appears" to be unapproved, placing the burden on
the importer to prove that the drug sought to be imported is in fact
approved by FDA. Absent evidence that the specific drugs sought to
be imported from a foreign country have been manufactured pursuant
to an approved new drug application, in the manufacturing facility
permitted under the application, such drugs would appear to be
unapproved new drugs subject to FDA enforcement action. The use of
FDA resources to provide comprehensive coverage of unapproved new
drugs imported for personal use is generally not justified, however,
the agency developed guidance in its Regulation Procedures Manual
(RPM) entitled "Coverage of Personal Importations" (copy enclosed).
This guidance sets forth the agency's enforcement priorities related
to the personal importation of unapproved new drugs, with
enforcement being focused on products apparently intended for the
commercial market and on fraudulent products and those that pose an
unreasonable health risk. The guidance recognizes that circumstances
may exist where, for example, a person has begun treatment with an
unapproved drug in a foreign country or suffers from a condition for
which there exists no FDA approved treatment. If such circumstances
can be substantiated, as the text of the guidance quoted below
notes, the guidance suggests that refraining from taking action
against the illegal importation, in the exercise of enforcement
discretion, may be appropriate. The guidance document is not,
however, a license for individuals to import unapproved (and
therefore illegal) drugs for personal use into the U.S., and even if
all the factors noted in the guidance are present, the drugs remain
illegal and FDA may decide that such drugs should be refused entry
or seized. Similarly, the factors noted in the guidance, and
documentation that should be obtained from individuals importing the
drugs, are not mandatory requirements. They are intended to guide
FDA enforcement discretion and should not be represented as binding
requirements. The statements in the RPM are intended only to provide
operating guidance for FDA personnel and are not intended to create
or confer any rights, privileges, or benefits on or for any private
person. That said, FDA's guidance for coverage of personal
importations of unapproved drugs identifies several factors that
should be considered by FDA personnel when determining whether to
exercise enforcement discretion and refrain from taking action
against the importation of unapproved drugs. The General Guidance
Section states that the FDA should consider not taking enforcement
actions against such importation: "When 1) the intended use [of the
drug] is unapproved and for a serious condition for which effective
treatment may not be available domestically either through
commercial or clinical means; 2) there is no known commercialization
or promotion to persons residing in the U.S. by those involved in
the distribution of the product at issue; 3) the product is
considered not to represent an unreasonable risk; and 4) the
individual seeking to import the product affirms in writing that it
is for the patient's own use (generally not more than 3 month
supply) and provides the name and address of the doctor licensed in
the U.S. responsible for his or her treatment with the product or
provides evidence that the product is for the continuation of a
treatment begun in a foreign country." (Emphasis added) The above
guidance does not specify that a U.S. citizen may import an
unapproved drug only with a prescription from a U.S. licensed
physician, or that a foreign citizen may import an unapproved new
drug only with a foreign prescription. Rather, to ensure that the
importation is for personal use only (and not for resale), and to
ensure that the use of the unapproved new drug sought to be imported
into the U.S. is supervised and does not represent an unreasonable
risk, the guidance provides that the individual affirm in writing
that the drug is for his or her personal use, and provide either the
name and address of the U.S. licensed physician who will supervise
its use or some evidence that the treatment was begun in a foreign
country and that the drugs are being imported to continue/conclude
the already begun treatment. Thus, while not the only documentation,
either a U.S. or foreign prescription, along with an affirmation of
personal use, could be supplied as evidence that this factor exists.
The guidance also provides that the importation should generally not
represent more than a 3 month supply of the unapproved products. The
purpose for this provision is in keeping with the intent that the
guidance relate to only drugs for personal use, not commercial
distribution. As the document sets forth only guidance, the 3 month
limitation is not a "requirement" or a "restriction." If an
individual presents evidence that he or she requires more than a 3
month supply for the full treatment of his or her illness, and it
appears that the reordering of a one or two month additional amount
may be inappropriate, FDA may consider the release of the full
amount. Similarly, if a foreign traveler to the U.S. seeks to import
unapproved drugs during his or her stay in the U.S., the amount
sought to be imported should represent the amount needed for
personal use during the U.S. visit. Where the evidence appears to
indicate that the drugs may be imported for commercial distribution,
the guidance provides that FDA should refuse admission of such
drugs. It must be emphasized that the intent of the personal use
importation guidance is to save FDA resources and to generally
permit, through the exercise of enforcement discretion, medical
treatments sought by individuals that are not otherwise available in
the United States (where such treatments are not
promoted/commercialized in the U.S.). Thus, foreign-made chemical
versions of drugs available in the U.S. are not intended to be
covered by the policy. For example, a person may decide that his or
her FDA approved heart medication is cheaper in Mexico, and attempt
to import the unapproved version of the drug from Mexico. FDA cannot
assure that such products have been properly manufactured and are
effective; therefore, given that such products are available in the
U.S., their use would present an unreasonable risk and the guidance
would not apply (unless the person seeking their importation could
establish that the drugs were needed to refill a prescription while
traveling or were otherwise needed while traveling). Likewise, a
drug such as Valium is available in the U.S. and, as such, a
foreign-made version of the U.S. approved drug would not generally
be considered a candidate to be permitted entry under the guidance.
However, because the United States Drug Enforcement Administration (DEA)
may have specific requirements that apply to the importation of
controlled substances such as Valium, FDA's guidance on personal
importations specifically provides that controlled substances should
be returned to Customs for handling. FDA will not approve a
particular form or format for information to accompany personal use
shipments, or approve any scheme proposed to facilitate the
importation of an unapproved new drug, because to do so would be to
imply that such importation meets FDA's personal importation
guidance and is legally permitted. Congress has the power to
determine which articles may be permitted importation into the
United States from a foreign source and the terms upon which the
importation will occur. An article subject to the Federal Food,
Drug, and Cosmetic Act is still in "interstate commerce" even if it
is purchased before being shipped across state lines. This is true
even if the article is intended solely for personal consumption.
Therefore, the Act properly regulates personal articles imported
into the United States for personal consumption. The Act also
prohibits the importation into the United States of any unapproved
new drug. We appreciate that there is a significant cost
differential between drugs available here and those in other
countries. However, many drugs sold in foreign countries as "foreign
versions" of approved prescription drugs sold in the United States
are often of unknown quality with inadequate directions for use and
may pose a risk to the patient's health. FDA approves a drug on the
basis of scientific data proving it to be safe and effective. FDA
approved labeling provides information on how and when the drug can
be used to maximize effectiveness and minimize any harmful side
effects. The manufacturing facilities and procedures for approved
products are also carefully regulated by FDA to ensure product
integrity. Since FDA cannot assure the consumer that the drug
purchased in the foreign country would be the same product his or
her physician's prescription is written for, we recommend the
product covered by the prescription be acquired in the United
States. drafted: Marvin A. Blumberg, HFC-170, 4/3/98
Drug Import
Fairness Act of 2000
(Engrossed in House ) 106th CONGRESS 2d
Session H. R. 3240 AN ACT To amend the Federal Food, Drug, and
Cosmetic Act to clarify certain responsibilities of the Food and
Drug Administration with respect to the importation of drugs into
the United States. HR 3240 EH 106th CONGRESS 2d Session H. R. 3240
--- AN ACT To amend the Federal Food, Drug, and Cosmetic Act to
clarify certain responsibilities of the Food and Drug Administration
with respect to the importation of drugs into the United States. Be
it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled, SECTION 1. SHORT TITLE.
This Act may be cited as the `Drug Import Fairness Act of 2000'.
SEC. 2. FINDINGS. The Congress finds as follows: (1) Pharmacists,
patients, and other persons sometimes have reason to import into the
United States drugs that have been approved by the Food and Drug
Administration (`FDA'). (2) There have been circumstances in which--
(A) a person seeking to import such a drug has received a notice
from FDA that importing the drug violates or may violate the Federal
Food, Drug, and Cosmetic Act; and (B) the notice failed to inform
the person of the reasons underlying the decision to send the
notice. (3) FDA should not send a warning notice regarding the
importation of a drug without providing to the person involved a
statement of the underlying reasons for the notice. SEC. 3.
CLARIFICATION OF CERTAIN RESPONSIBILITIES OF FOOD AND DRUG
ADMINISTRATION WITH RESPECT TO IMPORTATION OF DRUGS INTO UNITED
STATES. Section 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381) is amended by adding at the end the following
subsection: `(g)(1) With respect to a drug being imported or offered
for import into the United States, the Secretary may not send a
warning notice to a person (including a pharmacist or wholesale
importer) unless the following conditions are met: `(A) The notice
specifies, as applicable to the importation of the drug, that the
Secretary has made a determination that-- `(i) importation is in
violation of section 801(a) because the drug is or appears to be
adulterated, misbranded, or in violation of section 505; `(ii)
importation is in violation of section 801(a) because the drug is
forbidden or restricted in sale in the country in which it was
produced or from which it was exported; `(iii) importation by any
person other than the manufacturer of the drug is in violation of
section 801(d); or `(iv) importation is otherwise in violation of
Federal law. `(B) The notice does not specify any provision
described in subparagraph (A) that is not applicable to the
importation of the drug. `(C) The notice states the reasons
underlying such determination by the Secretary, including a brief
application to the principal facts involved of the provision of law
described in subparagraph (A) that is the basis of the determination
by the Secretary. `(2) The term `warning notice', with respect to
the importation of a drug, means a communication from the Secretary
(written or otherwise) notifying a person, or clearly suggesting to
the person, that importing the drug is, or appears to be, a
violation of this Act.'. Passed the House of Representatives June 29
(legislative day, June 28), 2000. |
