69 lines
4.2 KiB
Plaintext
69 lines
4.2 KiB
Plaintext
|
|
|
|
P92-3 Food and Drug Administration
|
|
FOR IMMEDIATE RELEASE Brad Stone -- (301)443-3285
|
|
Jan. 30, 1992 (Home) -- (703)892-0468
|
|
|
|
|
|
The Food and Drug Administration announced today it has issued an import
|
|
alert against unapproved mail-order drugs promoted by six overseas companies.
|
|
Many of these drugs are illegally advertised in periodicals and through
|
|
direct mail, as foreign versions of approved prescription drugs. The
|
|
promotion and distribution of unapproved drug products within the United
|
|
States is illegal.
|
|
"In some cases, the drugs are counterfeit -- lacking any real similarity
|
|
to the approved drug. The uncertain character and quality of these drugs
|
|
constitute an unreasonable risk to the public health," FDA Commissioner
|
|
David A. Kessler, M.D., said.
|
|
The import alert instructs FDA field offices to automatically detain all
|
|
imported unapproved prescription products manufactured by six overseas
|
|
companies which have promoted their products in this country. The companies
|
|
cited are Interpharm, Inc., of Nassau, Bahamas; Northam Medication Service
|
|
International Pharmacy of Nassau, Bahamas; Inhome Services of Delemont,
|
|
Switzerland; International Products of Hannover, Germany; Azteca Trio
|
|
Internacional, S.A. de C.V., of Zona Rio Tijuana, Mexico; and Interlab of
|
|
London, England.
|
|
These companies have been promoting a wide variety of products purported
|
|
to treat various conditions, including depression, high blood pressure,
|
|
fungal infections, fatigue, chronic bronchitis and hair loss.
|
|
Many of the ads for these unapproved drugs claim that people can save
|
|
money on the costs of prescription drugs, but in reality the drugs may pose
|
|
a risk to the patient's health. Dr. Kessler said so-called "foreign
|
|
versions" of prescription drugs are often of unknown quality with inadequate
|
|
directions for use.
|
|
For many years FDA has permitted -- and will continue to permit -- its
|
|
field offices to exercise discretion regarding the release for entry into
|
|
the United States of small "personal-use" quantities of drugs sold abroad
|
|
but not approved in the United States -- provided that the drugs do not pose
|
|
unreasonable safety risks, that their use is not promoted in the United
|
|
States and that they are for a serious condition for which there is no
|
|
satisfactory treatment available in this country. The policy was designed
|
|
to give FDA field offices discretion to release small quantities of
|
|
medicines with which individuals returning to the United States may have
|
|
been treated while traveling abroad and to allow individuals with serious
|
|
conditions the ability to import, under certain limited conditions,
|
|
personal-use quantities of unapproved drugs that they believe might be
|
|
helpful in treating their conditions.
|
|
Personal-use quantities are generally considered to be amounts for a
|
|
patient's treatment for three months or less. Imports involving larger
|
|
quantities are not permitted as they lend themselves to commercialization.
|
|
FDA approves drugs on the basis of scientific data proving them to be
|
|
safe and effective. FDA-approved labeling provides information on how and
|
|
when the drugs can be used to maximize their effectiveness and minimize
|
|
their harmful side effects. The manufacturing facilities and procedures for
|
|
approved products are also carefully regulated by FDA to ensure product
|
|
integrity.
|
|
The unapproved drugs promoted by these overseas operations lack these
|
|
safeguards and quality assurance standards.
|
|
Consumers should also be aware that the acquisition and use of
|
|
prescription drugs without the valid prescription of a physician or other
|
|
licensed health professional may violate state or local laws. FDA warns
|
|
that severe adverse reactions, including death, can result from the improper
|
|
use of prescription drugs.
|
|
Persons with questions about importation of drugs for personal use
|
|
should consult with their local FDA district office or the FDA Imports
|
|
Operations Branch in Rockville, Md., at (301) 443-6553.
|
|
The Food and Drug Administration is one of the eight Public Health
|
|
Service agencies within HHS.
|
|
###
|