amomynous

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00948.html

------------------------

FDA News
FOR IMMEDIATE RELEASE
P03-73
September 29, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially
Dangerous Imported Drug Shipments

A recent series of spot examinations of mail shipments of foreign drugs
to U.S. consumers conducted by the Food and Drug Administration (FDA)
and U.S. Customs and Border Protection (CBP or Customs) revealed that
these shipments often contain dangerous unapproved or counterfeit drugs
that pose potentially serious safety problems. This joint operation was
carried out to help FDA and CBP target, identify, and stop counterfeit
and potentially unsafe drugs from entering the United States from
foreign countries via mail and common carriers. It was also designed to
help FDA and CBP assess the extent of this problem.

These blitz exams were conducted in the Miami and New York (JFK) mail
facilities from July 29-31, 2003, and the San Francisco, and Carson,
Calif., mail facilities from August 5-7 2003, to obtain a representative
picture of products entering the United States. In each location,
packages shipped by international mail through U.S. Postal Service
facilities over a 3-day time span were examined. For the purposes of
these blitzes FDA and CBP identified, through review of historical data
and experience, those packages likely to contain drug products. For
example, packages were considered if they were from countries from which
drugs are known to be exported via the mail. Due to the speed at which
parcels are automatically processed and transported through the mail
facilities, country of origin was the only specific criterion that could
be consistently applied to all parcels.

Approximately 100 parcels (each of which may have contained multiple
drug products) per day per facility were selected based upon their
country of origin and historical experience. They were subsequently
opened by CBP and jointly examined by both Agencies. Those in violation
of CBP provisions were held by CBP. Those in violation of FDA
regulations were detained by FDA.
In general, FDA and CBP do not have sufficient resources to perform
comprehensive examinations of all mailed packages due to the huge volume
of parcels entering the United States through international mail and
courier services, the consuming time requirements for processing and
returning illegally imported drugs, and multiple, competing enforcement
priorities. For example, the Carson, Calif., mail facility alone
receives over 10,000 parcels per day.

Although many drugs obtained from foreign sources purport, and may even
appear to be, the same as FDA-approved medications, these examinations
showed that many are of unknown quality or origin. Of the 1,153 imported
drug products examined, the overwhelming majority, 1,019 (88%), were
violative because they contained unapproved drugs. Many of these
imported drugs could pose clear safety problems.
These drugs arrived from many countries. For example,15.8% (161) entered
the U.S. from Canada; 14.3% (146) from India; 13.8% (141) from Thailand;
and 8.0% (82) from the Philippines. The remaining entries came from
other countries.

This joint effort with CBP illustrates the real and serious public
health risks created by the importation of unapproved drugs,? said Mark
B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. ?To protect
Americans from unsafe imported drugs, we are working to target our
enforcement resources as effectively as possible against those products
that pose a threat to the health of consumers and the safety and
security of our drug supply.?
?This action represents an important step forward in keeping harmful or
illegal drugs from entering the country,? said Customs and Border
Protection Commissioner, Robert C. Bonner. ?Although CBP?s priority
mission is preventing terrorists and terrorist weapons from entering the
United States, CBP continues to perform its traditional mission by
working with the FDA to identify and interdict illegal and dangerous
drugs that could threaten public health and safety.?

The potentially hazardous products found in these blitz exams revealed:
Drugs different from those approved by FDA -- Drugs that FDA has never
approved are being imported. For example, Roaccutane (an unapproved
version of Accutane) is being imported from Thailand. In the United
States, prescribers of Accutane (a drug to treat a severe form of acne)
are required to monitor patients to avoid certain serious risks such as
birth defects that may occur following use of the drug. Taro-warfarin
(an apparently unapproved version of Warfarin) from Canada is also being
imported. Warfarin is used to prevent blood clotting and its potency may
vary depending on how it is manufactured. Because it can cause serious,
life-threatening bleeding if not administered appropriately, it requires
careful monitoring by a health care provider of a patient?s blood count
during treatment.

Drugs requiring careful dosing -- Drugs such as unapproved versions of
Dilantin (from Philippines); unapproved versions of Synthroid (from
Canada); and unapproved versions of Glucophage (from Canada and
Philippines) that require individual titration and
very careful dosing to avoid serious life-threatening side effects are
being imported.
Drugs with inadequate labeling -- Moreover, most of these drugs came
without adequate labeling or instructions for proper, safe use. Some of
the drug labeling was not in English and important information about
matters such as proper dosage was often missing.

Drugs inappropriately packaged -- In some cases, these drugs were
inappropriately packaged in baggies, tissue paper, or letter envelopes.
In other instances, the imported drugs arrived crushed and broken.

Drugs withdrawn from the market -- Consumers are importing drugs that
FDA has withdrawn from the market for safety reasons. For example, one
unapproved drug that came from Mexico, Buscapina, appears to be the drug
Dipyrone that was removed from the U.S. market in 1977 because of
several reports of the development of severe blood disorders following
the drug?s administration, some of which resulted in fatalities;

Animal drugs not approved for human use -- Animal drugs that FDA has not
approved for humans use are being imported. For example, Clenbuterol, a
drug approved for the treatment of airway disease in horses but that has
not been approved for human use and has been banned by the International
Olympic Committee as a performance enhancing drug, came from Costa Rica
and China;

Drugs with dangerous interactions -- Drugs such as ketoconazole (from
Thailand) ? unapproved versions of Viagra (from United Kingdom, India,
Philippines and Japan); and unapproved versions of Zocor (from Canada)
are being illegally imported and have the potential to cause clinically
significant interactions with other drugs which consumers may be taking;
Drugs that carry risks requiring initial screening and/or periodic
patient monitoring -- Drugs such as unapproved versions of Lipitor (from
Ireland, Thailand, Japan, Philippines, Canada, Argentina, New Zealand,
England and Brazil); and unapproved versions of Pravachol (from Canada)
are being illegally imported. Initial screening and periodic patient
monitoring by a medical professional (e.g. monitoring liver function)
are recommended in FDA?s approved labeling for these drugs to help
assure their safe use;
Controlled substances -- Over 25 different controlled substances were
offered for import including Diazepam (from Canada, Thailand,
Philippines, Costa Rica, Malaysia, New Zealand, and India); Xanax (from
Philippines); Codeine (from Canada, Philippines, Costa Rica, United
Kingdom, New Zealand, Thailand, Guatemala, China, Peru, and Taiwan);
Valium (from Philippines and Thailand); and anabolic steroids (from
Costa Rica). These drugs were referred to the Drug Enforcement
Administration. Controlled substances pose serious safety issues for
consumers because they are dangerous narcotics that have abuse potential
for patients who take them inappropriately or without the proper
physician supervision.
The blitz is also helpful in understanding trends in the illegal
importation of unsafe drugs. In 2001, FDA conducted a similar ****ysis
that prompted the same concerns about the risk of these imported drugs.
Compared to the 2001 results at the Carson mail facility, this most
recent blitz uncovered a somewhat larger number of imports, including a
larger number of unapproved drugs and drugs that appeared to be
counterfeits. The blitz FDA conducted at the Carson mail facility in
2001, as well as the most recent blitz conducted by FDA in coordination
with Customs, illustrate the type of regular surveillance activities
involving imported drug products that FDA undertakes. As a result of the
current blitz, we are re-evaluating the enforcement strategies and
objectives we use to target the entry of unapproved and/or counterfeit
drug products through international mail facilities.
?There is no evidence that unapproved imported drugs are becoming any
safer or more reliable,? said Dr. McClellan. ?Given FDA?s limited
resources and authorities to detect and block potentially unsafe
imports, we are concerned about any measures that would increase the
flow of these unapproved drugs, or provide easier channels for them to
enter the United States.

The blitz results will assist the Agency in its efforts to:
Utilize its investigatory and regulatory resources more strategically to
focus on the foreign sources of illegal, unsafe imported drugs;

Identify shipping patterns specific to identified sources of unsafe
drugs so that it can target future shipments and sources of such drugs;
and
Seek out partnerships with other federal and state agencies to combat
this problem.

In addition, FDA will continue its efforts to educate the public about
the dangers of drugs through illegal, poorly-regulated, and potentially
unsafe foreign channels.
*

your.name

Interesting that this is all they would say about Viagra....

jack frost

It is most likely that the "blitzes" are not to protect the public but
instead to protect the huge profits of the drug companies gouging us in the
good ol' USA.


http://www.fda.gov/bbs/topics/NEWS/2003/NEW00948.html

------------------------

FDA News
FOR IMMEDIATE RELEASE
P03-73
September 29, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially
Dangerous Imported Drug Shipments

A recent series of spot examinations of mail shipments of foreign drugs
to U.S. consumers conducted by the Food and Drug Administration (FDA)
and U.S. Customs and Border Protection (CBP or Customs) revealed that
these shipments often contain dangerous unapproved or counterfeit drugs
that pose potentially serious safety problems. This joint operation was
carried out to help FDA and CBP target, identify, and stop counterfeit
and potentially unsafe drugs from entering the United States from
foreign countries via mail and common carriers. It was also designed to
help FDA and CBP assess the extent of this problem.

These blitz exams were conducted in the Miami and New York (JFK) mail
facilities from July 29-31, 2003, and the San Francisco, and Carson,
Calif., mail facilities from August 5-7 2003, to obtain a representative
picture of products entering the United States. In each location,
packages shipped by international mail through U.S. Postal Service
facilities over a 3-day time span were examined. For the purposes of
these blitzes FDA and CBP identified, through review of historical data
and experience, those packages likely to contain drug products. For
example, packages were considered if they were from countries from which
drugs are known to be exported via the mail. Due to the speed at which
parcels are automatically processed and transported through the mail
facilities, country of origin was the only specific criterion that could
be consistently applied to all parcels.

Approximately 100 parcels (each of which may have contained multiple
drug products) per day per facility were selected based upon their
country of origin and historical experience. They were subsequently
opened by CBP and jointly examined by both Agencies. Those in violation
of CBP provisions were held by CBP. Those in violation of FDA
regulations were detained by FDA.
In general, FDA and CBP do not have sufficient resources to perform
comprehensive examinations of all mailed packages due to the huge volume
of parcels entering the United States through international mail and
courier services, the consuming time requirements for processing and
returning illegally imported drugs, and multiple, competing enforcement
priorities. For example, the Carson, Calif., mail facility alone
receives over 10,000 parcels per day.

Although many drugs obtained from foreign sources purport, and may even
appear to be, the same as FDA-approved medications, these examinations
showed that many are of unknown quality or origin. Of the 1,153 imported
drug products examined, the overwhelming majority, 1,019 (88%), were
violative because they contained unapproved drugs. Many of these
imported drugs could pose clear safety problems.
These drugs arrived from many countries. For example,15.8% (161) entered
the U.S. from Canada; 14.3% (146) from India; 13.8% (141) from Thailand;
and 8.0% (82) from the Philippines. The remaining entries came from
other countries.

This joint effort with CBP illustrates the real and serious public
health risks created by the importation of unapproved drugs,? said Mark
B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. ?To protect
Americans from unsafe imported drugs, we are working to target our
enforcement resources as effectively as possible against those products
that pose a threat to the health of consumers and the safety and
security of our drug supply.?
?This action represents an important step forward in keeping harmful or
illegal drugs from entering the country,? said Customs and Border
Protection Commissioner, Robert C. Bonner. ?Although CBP?s priority
mission is preventing terrorists and terrorist weapons from entering the
United States, CBP continues to perform its traditional mission by
working with the FDA to identify and interdict illegal and dangerous
drugs that could threaten public health and safety.?

The potentially hazardous products found in these blitz exams revealed:
Drugs different from those approved by FDA -- Drugs that FDA has never
approved are being imported. For example, Roaccutane (an unapproved
version of Accutane) is being imported from Thailand. In the United
States, prescribers of Accutane (a drug to treat a severe form of acne)
are required to monitor patients to avoid certain serious risks such as
birth defects that may occur following use of the drug. Taro-warfarin
(an apparently unapproved version of Warfarin) from Canada is also being
imported. Warfarin is used to prevent blood clotting and its potency may
vary depending on how it is manufactured. Because it can cause serious,
life-threatening bleeding if not administered appropriately, it requires
careful monitoring by a health care provider of a patient?s blood count
during treatment.

Drugs requiring careful dosing -- Drugs such as unapproved versions of
Dilantin (from Philippines); unapproved versions of Synthroid (from
Canada); and unapproved versions of Glucophage (from Canada and
Philippines) that require individual titration and
very careful dosing to avoid serious life-threatening side effects are
being imported.
Drugs with inadequate labeling -- Moreover, most of these drugs came
without adequate labeling or instructions for proper, safe use. Some of
the drug labeling was not in English and important information about
matters such as proper dosage was often missing.

Drugs inappropriately packaged -- In some cases, these drugs were
inappropriately packaged in baggies, tissue paper, or letter envelopes.
In other instances, the imported drugs arrived crushed and broken.

Drugs withdrawn from the market -- Consumers are importing drugs that
FDA has withdrawn from the market for safety reasons. For example, one
unapproved drug that came from Mexico, Buscapina, appears to be the drug
Dipyrone that was removed from the U.S. market in 1977 because of
several reports of the development of severe blood disorders following
the drug?s administration, some of which resulted in fatalities;

Animal drugs not approved for human use -- Animal drugs that FDA has not
approved for humans use are being imported. For example, Clenbuterol, a
drug approved for the treatment of airway disease in horses but that has
not been approved for human use and has been banned by the International
Olympic Committee as a performance enhancing drug, came from Costa Rica
and China;

Drugs with dangerous interactions -- Drugs such as ketoconazole (from
Thailand) ? unapproved versions of Viagra (from United Kingdom, India,
Philippines and Japan); and unapproved versions of Zocor (from Canada)
are being illegally imported and have the potential to cause clinically
significant interactions with other drugs which consumers may be taking;
Drugs that carry risks requiring initial screening and/or periodic
patient monitoring -- Drugs such as unapproved versions of Lipitor (from
Ireland, Thailand, Japan, Philippines, Canada, Argentina, New Zealand,
England and Brazil); and unapproved versions of Pravachol (from Canada)
are being illegally imported. Initial screening and periodic patient
monitoring by a medical professional (e.g. monitoring liver function)
are recommended in FDA?s approved labeling for these drugs to help
assure their safe use;
Controlled substances -- Over 25 different controlled substances were
offered for import including Diazepam (from Canada, Thailand,
Philippines, Costa Rica, Malaysia, New Zealand, and India); Xanax (from
Philippines); Codeine (from Canada, Philippines, Costa Rica, United
Kingdom, New Zealand, Thailand, Guatemala, China, Peru, and Taiwan);
Valium (from Philippines and Thailand); and anabolic steroids (from
Costa Rica). These drugs were referred to the Drug Enforcement
Administration. Controlled substances pose serious safety issues for
consumers because they are dangerous narcotics that have abuse potential
for patients who take them inappropriately or without the proper
physician supervision.
The blitz is also helpful in understanding trends in the illegal
importation of unsafe drugs. In 2001, FDA conducted a similar ****ysis
that prompted the same concerns about the risk of these imported drugs.
Compared to the 2001 results at the Carson mail facility, this most
recent blitz uncovered a somewhat larger number of imports, including a
larger number of unapproved drugs and drugs that appeared to be
counterfeits. The blitz FDA conducted at the Carson mail facility in
2001, as well as the most recent blitz conducted by FDA in coordination
with Customs, illustrate the type of regular surveillance activities
involving imported drug products that FDA undertakes. As a result of the
current blitz, we are re-evaluating the enforcement strategies and
objectives we use to target the entry of unapproved and/or counterfeit
drug products through international mail facilities.
?There is no evidence that unapproved imported drugs are becoming any
safer or more reliable,? said Dr. McClellan. ?Given FDA?s limited
resources and authorities to detect and block potentially unsafe
imports, we are concerned about any measures that would increase the
flow of these unapproved drugs, or provide easier channels for them to
enter the United States.

The blitz results will assist the Agency in its efforts to:
Utilize its investigatory and regulatory resources more strategically to
focus on the foreign sources of illegal, unsafe imported drugs;

Identify shipping patterns specific to identified sources of unsafe
drugs so that it can target future shipments and sources of such drugs;
and
Seek out partnerships with other federal and state agencies to combat
this problem.

In addition, FDA will continue its efforts to educate the public about
the dangers of drugs through illegal, poorly-regulated, and potentially
unsafe foreign channels.

rich

Yes, very true.. I agree. And why protect the huge profits of drug
companies? These drug companies have NOT cured anything since 1954 (when
they cured polio)!!!

marek williams

On Thu, 9 Oct 2003 16:07:30 -0400, "Jack Frost"
<Provocative_Name@hotmail.com> dijo:

You're right that the blitzes were not to protect the public. But
protecting the profits of the drug companies and doctors were
secondary purposes. The real reason was to protect the FDA and CBP
employees' jobs.

Read it again and note how it hypes the evil effects of these
"unapproved" drugs and makes it sound like we need even more
enforcement employees.

It's all bogus, of course. Like drugs from Canada are "counterfeit" or
"potentially unsafe." If I were a Canadian I'd be insulted. Sure,
there are countries where standards are not as high as in the U.S.,
but most of the countries on their list are not among them. In fact,
in all the posts in here about drugs purchased from abroad, I can't
recall a single case where someone got bad drugs. I know the
hypertension meds I get from India work exactly like the ones I used
to buy at U.S. drugstores.

And one of the things they conveniently left out is the improved
health of U.S. citizens because they can finally afford the drugs they
need.

--
Bogus e-mail address, but I read this newsgroup regularly, so reply here.

rich

Look at the wording...it's the wording... the wording of this "news" item
that makes it look like they're onto something important.

For example, they say "often contain dangerous, unapproved, or
counterfeit... that pose potentially serious safety problems".

Give me a break.... domestic shipments of Bone Meal Supplements often
contain dangerous, unapproved, or counterfeit ingredients... that pose
"potentially serious safety problems"... and because of that you want to
confiscate our Bome Meal supplements, too?

Or, how about an ordinary Hammer? A hammer often contains dangerous,
unapproved, or counterfeit parts... and the Hammer poses "potentially
serious safety problems"...and because of that you want to confiscate our
Hammers, too?

The truth is, most of the countries on their list have high standards. In
fact, in all the posts -- in here and elsewhere -- about drugs purchased
from abroad, I can't recall a single incident where someone received bad
drugs from abroad. I do know the
thyroid meds I get from Greece, Mexico and Canada work exactly like the ones
I used to buy at U.S. drugstores.

Accidentally or on purpose, one of the things they forgot to mention is the
improved health of U.S. citizens.... because now we can finally afford the
drugs we need.

How about victims of AIDS, Alzerhemer's, Parkinson's, Cancer, MS, CF and
hundreds of other diseases? Would you rather see good American people DIE or
suffer greatly, when they cannot afford the outrageous prices charged by
U.S. drugstores?

r.coyote

from LEF.ORG

Dear Life Extension Supporter,

The future of affordable health care resides in the U.S. Senate, where a
fierce debate rages over the prescription drug import bill that was passed
by the House of Representatives on July 25, 2003.

Drug company propagandists are inundating Congress and the media with
blatantly false reports that Canadian prescription drugs are dangerous. The
FDA is backing the drug industry with baseless allegations that these
imported prescription drugs cannot be trusted.

What makes the FDA's position particularly absurd is the fact that
prescription drug counterfeiting has become rampant in the United States,
where high drug prices induce unscrupulous wholesalers to sell bogus
medications to American pharmacies. (Source: Wall Street Journal, September
22, 2003) Despite FDA and drug company rhetoric, Americans have been
importing lower-cost medications from other countries for decades, and there
have been no reports of an adulterated drug causing harm (Source: The FDA,
which has yet to produce a victim). Americans are being exposed to scare
tactics to protect the astronomical profits of the pharmaceutical industry
(Source: http://www.stopfda.org).

The Pharmaceutical Market Access Act of 2003 (that the Senate is now
debating) contains provisions that would make drugs imported from Canada
safer than those obtained in American pharmacies under current regulatory
guidelines.

The encouraging news is that the word is getting out about how Americans are
grossly overcharged for their prescription medications. Increasing numbers
of senior citizens are ordering their prescription drugs from Canada at
substantially lower prices.

On August 7, 2003, the AARP launched a lobbying campaign to encourage
Senators to pass The Pharmaceutical Market Access Act of 2003 (H.R. 2427).
AARP issued a statement to Congress that Americans can no longer afford the
steep prices of medications and supported opening up the market to
lower-cost foreign competition. The lead editorial in the New York Times on
September 20, 2003 endorsed passage of the bill that would provide Americans
access to these lower-cost medications from other countries.

Most surprising is news that some cities and states are encouraging their
employees to order prescription drugs from Canada in order to reduce the
healthcare budget. The FDA is warning officials from these cities and states
that it is illegal for Americans to import medications from Canada, but some
city officials are rebelling against the FDA's edicts. (Source: Wall Street
Journal, August 27, 2003)

It is crucial that the Senate pass the Pharmaceutical Market Access Act of
2003 (H.R. 2427) without any amendments that would provide the FDA with
loopholes to deny Americans unfettered access to lower-cost medications. Our
concern is that public pressure will force the Senate to pass a watered-down
version of the House bill that will contain a "poison pill" that will give
the FDA bureaucratic excuses to deny Americans access to affordable
medications.

It is now easier than ever to contact your two Senators and urge them to
pass the Pharmaceutical Market Access Act of 2003. Just click here
(http://www.senate.gov) and you can gain instant email access to your two Senators.
Because of anthrax threats, sending regular mail to members of Congress is
no longer the ideal way of conveying your message. Senate staffers now
prefer emails or faxes.

Please click on to this link (http://www.senate.gov) to access the Senate's web
page and to ask your two state Senators to pass the Pharmaceutical Market
Access Act of 2003 (HR 2427). At the end of this message is a model letter
that you can cut and paste into an email directly to your Senators.

While the drug import issue is now a hot political topic, it was the Life
Extension Foundation that originally enlightened Americans to the fact that
identical medications could be purchased for far less money from other
countries. After battling the FDA, the media, and the drug companies for
more than 20 years, we have a realistic chance of getting legislation passed
that will give you the right to chose where you purchase your prescription
drugs.

Please take the few minutes of time to email your two Senators a copy of the
letter that appears at the end of this do***ent.

For longer life,

William Faloon

Letter to send to your two Senators:

The Honorable Senator__________________

Washington, D.C. 20510

Dear Senator:

I am writing to encourage you to put your full support behind the
Pharmaceutical Market Access Act of 2003 (HR 2427).

If this House bill is passed intact, it will provide American consumers with
legal access to lower-cost medications from other countries that will have
safety standards comparable to those of the United States. The
Pharmaceutical Market Access Act of 2003, as passed by the House on July 25,
2003, contains specific provisions to guard consumers against unsafe and
counterfeit drugs.

When considering this legislation, I ask that you:

1) Make sure the Pharmaceutical Market Access Act of 2003 (HR 2427) is
included in any Medicare reform bill.

2) Check to see the bill allows consumer access to the 25 countries
approved by the FDA in year 2000, and retained in the version of the
Pharmaceutical Market Access Act of 2003 most recently passed by the House
(H.R. 2427).

3) Verify that there is no "poison pill" in the Senate version of this
bill that would provide the FDA with a bureaucratic loophole to deny
consumers access to more competitively priced prescription drugs. There are
already enough safety provisions in the House's version of the bill to
protect consumers against counterfeit drugs.

Please confirm by return email what actions you are taking to make sure the
Senate passes the Pharmaceutical Market Access Act of 2003 (H.R. 2427) with
NO poison pill provision.

Sincerely,

Name:

Street:

City: ST
Zip

Email: