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Commentary on the FDA Import Bulletin
"In 1988 the FDA issued a directive regarding the importation
of medications for personal use. This came about as a result
of the tremendous pressure the FDA got from senior citizens,
aids activists etc. In addition, drug prices were outpacing
inflation by some 12%. The FDA decided to allow some experimental
drugs to be imported that had not been approved by the FDA.
Their guideline was a 90 day supply, for personal use only.
It takes the FDA years and endless red tape to approve a
new drug. According to their guidelines, this did not include
drugs already approved in the USA, nor did it allow the importation
of controlled substances.
The then current director of the FDA had the foresight to
realize to potential corruption of his agency in the future
by commercial enterprises, such as US drug manufacturers and
retail chains, so this FDA provision was set-up so it could
not be modified nor deleted by future FDA administrations.
Soon after, millions of people began importing medications
of all kinds with the exception of illegal or banned medications.
Pharmacies all over the world started websites promoting their
products. Because of pressure from congress and to a lesser
extent, the public, (who were getting ripped off), the FDA
began cracking down on overseas websites that promoted their
products. With the cooperation of the Thailand Government,
they began shutting down Thailand sites many that were unregulated
and associated with organized mobsters. They also began seizing
almost every parcel that came out of Thailand.
Soon after that, the FDA began to issue warning letters to
overseas pharmacies that were commercially promoting their
products and put many of these sites on import alert which
means the parcels were to be opened and seized. They then
sent the recipient a letter, which said, in effect, the medications
you ordered were not manufactured in the USA and since the
FDA did not approve them, they posed a risk to the citizen's
health.
The letter they sent had no teeth to it. Millions of people
threw them away and kept right on ordering. The reason was
that there was a very small chance a parcel would be opened
considering the millions that were coming over the border
every day.
Today, there is outrage over the high cost of medications
and congress is finally listening to their constituents. For
the most part, medications manufactured overseas are tested
just like they are here. The only difference is that big drug
companies do not influence overseas governments the way they
do here.
As a result, the folks on Capitol Hill are telling the FDA
to chill out. If a citizen can get an antibiotic overseas
for half the price, they should be allowed to do so. They
are telling the FDA to stop stealing people's medications
and to cease and desist the irritating, yet toothless letters
sent to USA citizens.
To give you an idea of the state of the Washington power
structure on this issue, consider that in the closing days
of the Clinton administration both houses of Congress unanimously
passed legislation removing all doubt about the importation
of drugs. (See article below import bulletin)
Unfortunately the legislation contained a provision that it
could not take effect without the approval of the FDA, and
that agency, which is notoriously cozy with the drug companies,
refused approval.
Consider however that the bureaucrats in the FDA are well
aware of the unanimous opinion of Congress and are therefore
highly unlikely to "rock the boat" by beginning
enforcement of the letter of the law.
This has not become law as of yet so caution is still warranted.
This is why we are including this commentary, to help you
interpret the wide ranging and confusing FDA regulations (see
more in FDA Bulletin below) and more importantly to keep you
away from the unscrupulous scammers that take advantage of
people in pain or other medical conditions."
Text of FDA Import Bulletin
U.S. Food & Drug Administration Bulletin
For Guidance In Handling Personal Importation Of
Personal (90
day supply) Of Drugs
[Pertinent portions only, emphasis supplied]
Imported Drugs
Persons wishing to ship a drug to the United States, and
persons in the United States wishing to import the same must
bear in mind that the article may be detained and refused
admission if it does not comply with the applicable drug provisions
of the Federal Food, Drug, and Cosmetic Act.
A drug which has been used outside the United States, and
which may be regarded as safe and effective by experts in
other countries, but which has not been marketed in this country,
is likely to be regarded as a new drug under the Federal Food,
Drug, and Cosmetic Act. A new drug will be admitted only if
the Food and Drug Administration has approved a New Drug Application
for it. However, exceptions to this
rule include drug importation for personal use only if specific
conditions are met.
COVERAGE OF PERSONAL IMPORTATIONS
GENERAL GUIDANCE
The statements in this chapter 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.
FDA personnel may use their discretion
to allow entry of shipments of violative FDA regulated products
when the quantity and purpose are clearly for personal use,
and the product does not present an unreasonable risk to the
user. Even though all products that appear to be in violation
of statutes administered by FDA are subject to refusal, FDA
personnel may use their discretion to examine the background,
risk, and purpose of the product before making a final decision.
Although FDA may use discretion to allow admission
of certain violative items, this should not be interpreted
as a license to individuals to bring in such shipments.
PURPOSE
To provide guidance for the coverage of personal-use quantities
of FDA-regulated imported products in baggage and mail and
to gain the greatest degree of public protection with allocated
resources.
BACKGROUND
Because the amount of merchandise imported into the United
States in personal shipments is normally small, both in size
and value comprehensive coverage of these imports is normally
not justified. This guidance clarifies how FDA may best protect
consumers with a reasonable expenditure of resources.
COMMERCIAL OR PROMOTIONAL SHIPMENTS
Commercial and promotional shipments are not subject to this
guidance. Whether or not a shipment is commercial or promotional
may be determined by a number of factors including, for example,
the type of product, accompanying literature, size, value,
and/or destination of the shipment. FDA personnel may also
consider whether an importation of drugs or medical devices
is a commercial shipment by evaluating whether the article
appears to have been purchased for personal use or whether
the quantity suggests commercial distribution (i.e., the supply
exceeds what one person might take in approximately three
months). Commercial shipments generally include shipments
other than those products that are personally carried, shipped
by a personal non-commercial representative of a consignee,
or shipped from a foreign medical facility where a person
has undergone treatment.
Drugs, Biologics, and Devices
When personal shipments of drugs
and devices that appear violative are brought to FDA's attention
by Customs, FDA personnel will use their discretion to decide
on a case-by-case basis whether to detain, refuse, or allow
entry of the product. Generally, drugs and devices
subject to Import Alerts are not amenable to this guidance.
Devices to be used by practitioners for treating patients
should not be viewed as personal importations subject to this
chapter. Drugs subject to Drug Enforcement Agency (DEA) jurisdiction
should be returned to Customs for handling.
In deciding whether to exercise discretion to allow personal
shipments of drugs or devices, FDA
personnel may consider a more permissive policy in the following
situations:
- When the intended use is appropriately
identified, such use is not for treatment of
a serious condition, and the product is not known to represent
a significant health risk; or
- when a) the intended use is unapproved and for
a serious condition for which effective treatment may
not be available domestically either through commercial
or clinical means; b) 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;
c) the product is considered
not to represent an unreasonable risk; and d) 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.
Clinton Administration Stops Congressional Bill
In one of it's last administrative acts, the Clinton Administration
refused to support the Congressional Bills, which were unanimously
passed by both the House and Senate this summer. Stating it's
case, Clinton representatives declared that the big pharmaceutical
business concerns in the USA would not be deterred by such
a law being passed. The spirit of the bill was to somehow
or other create opportunity for those who can not afford their
prescription medications here in the USA an alternative, by
giving them more facility to purchase foreign equivalents.
The bill however did not address the facility now existing
for personal imports, but rather with the proposition of allowing
"pharmacists" the facility to purchase meds wholesale
from abroad and then to sell them to those with a prescription
in the USA, in much the same way they currently sell generics.
In an article released today by the New York Times News Service
(see below). The Administration took
special care to mention that this defeat of the proposed legislation
is not meant to discourage personal import of meds in 90-day
supply for consumers. And essentially announces to all those
who may not know as much, that such facility exists. More
importantly this acknowledgment by Congressional leaders of
the need for such alternatives has now been squarely placed
in public view, removing the stigma long associated with personal
import of meds for medical need.
Some Remarks About Safety
The term safety is often used in a simplistic and misleading
manner. Safety depends on many particulars of the individual
case. For example, one of the authors of this Web site (Klein)
ingests ten milligrams of a blood thinner called Warfarin
every day. Warfarin is also available in hardware stores as
rat poison. When mixed with something tasty, rats gobble it
up and die from internal bleeding. Humans with vascular problems
reduce risks of thrombosis by ingesting small amounts of rat
poison. Large amounts would be deadly. Dosage and condition
are just two of the many factors that affect safety.
Is chemotherapy safe? Medicine is often poison. University
of Iowa professor of medicine William
B. Bean (1970) explained the point as follows:
[T]he power of a drug [usually] carries
with it almost in parallel a potential for dangerous reactions.
. . . [E]ach person in the world is biochemically, anthropologically,
genetically, and in any other way you wish individual and
unique. The postulate that there is a dose, a fixed dose,
of a drug which is routine for any person with a specific
disease-a standard to be applied by pressing a button in
a kind of therapeutic automat-is irrational. Absorption
varies. Internal bodily metabolisms are different. At one
end of the spectrum there are persons who react idiosyncratically
or allergically to a drug. In addition there are sensitivities
that exist without harming a person at all until he encounters
a biochemical agent to which he may have a violent reaction,
even though the majority of people exposed to the same thing
do not react in that way. After a while he may learn not
to revolt against its administration. . . . [I]n the practice
of medicine we should remember that [powerful and potent
drugs] are two-edged swords that cut back at you if you
are not very careful in the way you wield them. With increased
potency we have increased danger. (132-33)
In 1994, it is estimated that at least 106,000 people died
from adverse reactions to "safe," FDA-approved drugs
(Lazarou
et al. 1998). (This figure includes only hospitalized
patients and does not include those people who died because
of medical error such as the prescribing of the wrong drug,
which also accounts for some 100,000 deaths every year [Kohn,
Corrigan, and Donaldson 1999].) It is inevitable that
many people, often in weakened and uncertain condition, will
suffer and die from unwanted side effects.
Despite the subtleties involved, the FDA is set up to screen
out "unsafe" drugs for all cases of usage, taken
in aggregate. But neither the administering of drugs by doctors
nor the taking of drugs by patients is done on an aggregate
basis. A drug stamped "safe" by the FDA is usually
not safe for every particular case or individual, and a drug
not so stamped is, nonetheless, safe for many particular cases
and individuals. As the Warfarin and chemotherapy examples
demonstrate, it might be "unsafe" both to take the
drug and not to take the drug. But the relevant benchmark
is not a state of perfect health. What really matters is whether
taking the drug is safer than not taking the drug. The people
intimately concerned in the situation and intimately informed,
not bureaucrats in Rockville, Maryland, should make this determination,
however.
The safety of a drug depends on myriad particulars about
the patient, including age, sex, physical strength, condition,
activities, allergies, diet, dosage, medical attention, and
drug regimen. Furthermore and importantly, what is "safe"
contains an unalterable subjective component (Higgs
1994). Patients faced with the same diseases will make
different treatment decisions depending on how they perceive
and evaluate the inherently risky trade-offs among health,
pain, and disability. The establishment of a single society-wide
standard of safety and efficacy does violence to the reality
of myriad individuals with different values and experiences.
We see the dilemma most clearly when the FDA withdraws an
"unsafe" drug from the market, and patients complain.
The drug Lotronex, for example, was withdrawn from the market
in November 2000 under pressure from the FDA. Lotronex was
prescribed for irritable bowel syndrome, a disease that causes
abdominal pain and intense bouts of diarrhea. In the ten months
that it had been on the market, some three hundred thousand
people used the drug without serious problem, but seventy
users developed a serious side effect, and three deaths were
possibly linked to the drug (Grady
2001). Lotronex is thus not without complications, but
it improved the lives of many patients to the extent of allowing
them to hold a job and leave their homes without fear of pain
or sudden attack of diarrhea. On learning that Lotronex might
be withdrawn, many of these patients went to great efforts
to stockpile the drug, and when it was indeed withdrawn, they
complained vociferously to the FDA. Patient complaints were
so extensive that in June of 2002 the FDA allowed the drug
back on the market so long as doctors and patients fulfilled
a number of conditions ensuring that both were fully informed
about the drug's potential complications.
The FDA's typical policy is "one size doesn't fit all,"
but the final outcome of the Lotronex example is encouraging.
The FDA could better serve all patients if instead of acting
paternalistically, by making choices on behalf of patients
whom it cannot know or understand, it focused on collecting
and disseminating information that people could utilize within
the context of their own lives.
It's important to recognize that the Lotronex case is unusual
because patients knew that the FDA had taken away a drug that
was beneficial to them. In the usual case, the FDA fails to
approve a drug that could have benefited patients, and the
patients never learn of the drug's possible existence. (On
the importance of what is seen and unseen in FDA policy, see
the glossary item Types
of FDA Error and the section FDA
Incentives.)
Owing to the nature of the products, we regret, pharmaceuticals
once purchased cannot be returned except under exceptional
circumstances.
Prohibitions to return medications once they leave the care,
custody and control of the pharmacy are contained in U.S.
Federal law and in the laws of most states, for reasons of
public health and sanitation.
If you feel yours' are exceptional circumstances (and believe
you deserve a refund) please write to us describing the reason
why you would like to return the consignment, and we will
examine your case to consider issuing you a refund or for
re-shipment.
Washington AP Story: Bill HR 4461
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.
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.
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