NTERF EIT MED ICINEES
COU E A R A N D P R E S E N T D A N G
One Company’s Experience
Around the World
Congress may soon resume debate on the in the world. While U.S. consumers can
issue of whether to permit importation of rest assured that the vast majority of the
medicines from foreign nations. prescription drugs they buy are safe and
effective, counterfeit medicines are
There are many reasons why Members of
increasingly becoming a problem.
Congress should oppose importation.
The FDA reports that counterfeiting
• Importation will not save money for
investigations have increased fourfold over
American patients under any of the
the past several years (from an average of
importation schemes being considered.
only about five per year through the late
(See CBO report, July 2004.)
1990s to over 20 per year since 2000).
• Importation would be the equivalent
For Pfizer, the safety of our medicines is always
of adopting the governmental health
foremost in our minds. We take this approach
systems of other nations, particularly the
not only to safeguard public health but also to
government-dictated price controls that
maintain public confidence in the Pfizer name
have done so much to stymie medical
and the integrity of our medicines.
research in other countries.
Reasonable people may disagree about
• Importation would undermine the
financing healthcare and the best way to
incentives for American medical research
provide medicines to those unable to get the
and undercut the role of your community’s
care they need. But, it is not reasonable to
physicians and pharmacists.
consider schemes that would open up
However, the most important reason to American borders to a surge of counterfeit
oppose importation is due to the growing and unapproved medicines.
global menace of counterfeit medicines.
These materials are provided to make you
Importation is opposed by all the federal
aware of the clear and present danger that
offices responsible for protecting American
counterfeit medicines pose and to ask
public health: the Food & Drug Administration
for your help in opposing legislation that
(FDA), the U.S. Department of Health &
would loosen protections against the unsafe
Human Services, U.S. Customs & Border
importation of medicines. The following are
Protection, and the U.S. Department of
a series of myths and misperceptions that are
driving the importation issue, and responses
The United States has a distribution system to those misleading notions.
that is generally considered to be the safest
COUNTERFEIT MEDICINES ARE
myth #1: ONLY A PROBLEM FOR PATIENTS
IN A FEW NATIONS.
Counterfeiting is an issue for the American pharmaceutical industry, just
as it is with other businesses such as the software, video and music
recording industries. However, the biggest difference is that you will not
die if you wear a counterfeit pair of Levi’s or play your next round of golf
with a counterfeit club. You could die if you take a tablet
of counterfeit medicine.
For years, it was a well-accepted belief that counterfeiting was a serious
problem only in China, India, and a few other developing countries. In
order to protect the supply of American medicines, Congress responded
in 1987 by passing the Prescription Drug Marketing Act (PDMA), Public
Law 100-293. The PDMA put restrictions on how medicines are moved
across American borders.
The problem became much worse in the 1990s. With the dawn of the
internet and other enhancements in technology, a new era in counterfeit
medicines began. What had been a problem in only a few, isolated locales
became a global industry. This now threatens to undermine public
confidence in the world’s supply of medicines.
An investigation by Pfizer Global Security identified a source in Thailand for the manufacture
of counterfeit Viagra tablets. An undercover investigator placed an order for 4,500 of the
counterfeit tablets and traveled to Bangkok, where he took delivery. The Thai National Police
were notified and took the seller into custody. Based on information he provided, authorities
raided this factory from which they seized 80,000 counterfeit Viagra tablets, counterfeit
packaging and manufacturing equipment.
The World Health Organization (WHO) concluded that about 10-20% of
drugs tested in developing countries fail the most basic quality tests, meaning
that the medicines are either
counterfeit or that they have not
been handled according to “We're now up against
manufacturer specifications. large and sophisticated
(See World Health criminal organizations
Counterfeit Drugs;” press release
with global reach and we
WHO/84, November 25, 1997. must address this problem
World Health Organization; on a global basis.”
Report of the WHO/IFPMA – John Theriault, Vice President, Pfizer Global Security.
Round Table Discussions,
Pfizer Global Security is headed by John Theriault,
November 3, 1999.)
a former Senior Executive with the Federal Bureau
of Investigation (FBI) with more than 25 years of law
enforcement experience. Pfizer Global Security now
consists of more than forty professionals with offices
in numerous countries around the world.
CaSe: NORVASC ®
Seizures of counterfeit versions of the high blood pressure medicine
Norvasc increased from less than 4,000 in 2002 to more than 1.5 million
in 2003, reflecting an alarming trend towards increased counterfeiting of
myth #2: COUNTERFEITTS BUY MEDICINES
Y AN ISSUE WHEN PATIEN
FROM ILLICIT OR UNTRUSTWORTHY SOURCES.
With an increasing number of counterfeit medicines, there was always
some comfort that these counterfeits mostly appeared in illegal or
unauthorized channels of distribution. That is, these counterfeit medicines
were sold in unlicensed venues where an intelligent person might be able
to surmise the possibility of risk. Today, that is no longer the case.
Counterfeits are no longer limited
The best way to avoid counterfeit drugs to unapproved pharmacies and
is to purchase prescription medicines at shady internet operations. The
legitimate channels of distribution
your local pharmacy from a reputable in developed nations, like the
pharmacist whom you know. United States, are now subject to
the dangers of counterfeits.
VIAGRA® COUNTERFEITING IN CANADA
In April 2003, authorities advised Pfizer about a major counterfeiting operation in
Canada; one that had targeted the U.S. A joint investigation conducted by the Royal
Canadian Mounted Police (RCMP) and the United States Drug Enforcement
Agency (DEA), led to the identification of Naturtek, a site in Quebec, that had been
manufacturing counterfeit Viagra.
In addition to two tablet presses and 32 counterfeit punches – 16 to deboss
“Pfizer” into the tablets, eight to deboss “VGR 100” and eight to deboss “VGR
50” – a search warrant executed at that site yielded 2.95 kg of counterfeit Viagra®
tablets (approximately 4,770 100mg tablets) and 5 kg of sildenafil citrate (enough
to make approximately 50,000 100mg or 100,000 50mg tablets).
COUNTERFEIT LIPITOR® IN U.S. SUPPLY CHAIN
In 2003, Pfizer saw the largest instance of counterfeit medicines being introduced
into legitimate U.S. distribution channels. In 2003, Pfizer assisted federal law
enforcement in the investigation of five U.S. firms involved in the distribution of
counterfeit Lipitor tablets. The most significant of those investigations concerned
counterfeit Lipitor tablets repackaged
by a company in Nebraska, and
distributed primarily by another
company in Missouri. At the end of
the investigation, FDA recalled more
than 18,000,000 counterfeit and
repackaged “Lipitor” tablets.
Pfizer first became aware of the
problem as a result of consumer
complaints that the tablets dissolved
quickly and tasted bitter. Tablets
were obtained from the consumers,
tested and found to be counterfeits These counterfeit tablets (left) were among those
containing Lipitor's active recalled from the U.S. supply chain in May 2003.
pharmaceutical ingredient. As you can see, they are virtually indistinguishable
from the authentic tablets (right). Visually, the
Lipitor is the most prescribed
only distinction between the tablets is that the
pharmaceutical product for the
counterfeits are slightly thicker than the
reduction of cholesterol in the
authentic. Pfizer was alerted to the presence of the
world. During 2003, for example,
counterfeits in the supply chain when consumers
68,958,000 prescriptions for Lipitor
complained that the tablets tasted bitter and
were written in the U.S. alone. To
dissolved more quickly than usual.
put the this case into perspective,
more than 600,000 U.S. residents --
after visiting their local pharmacy, or placing an order by phone, mail or internet --
may have received a thirty day supply of Lipitor that contained counterfeit tablets.
myth #3: COUNTERFEITYMEDICINES ARE
MADE BY ONL SMALL-TIME
Recent cases have demonstrated to Pfizer the sophistication of
counterfeiters. Chemical analysis of the counterfeit medicines in the
Lipitor® case revealed that all of the counterfeit product had the same
chemical formulation. This suggests that these fakes were manufactured by
the same source, one capable of producing large quantities of counterfeit
pharmaceutical products with a consistent chemical formulation. The
production of these counterfeits seems to have been done at a fairly large-
scale plant with sophisticated equipment. Counterfeiting is a big business.
Pfizer’s experience has shown that the major counterfeiting threat to the
American pharmaceutical supply is not from within the United States but
from other countries. The problem is worsened by the complicity of some
foreign governmental offices in the illegal operations. This government
“protection” has only made the job of cracking down on international
counterfeits even more difficult. However, there are signs of hope, like our
agreement with authorities in Shanghai.
In May 2004, Pfizer signed an agreement with regulatory authorities in
Shanghai to join forces to more effectively detect and deter the presence
of counterfeit medicines. The joint effort is unique within the global
pharmaceutical industry. Under this agreement, Pfizer will provide
those agencies with
which they will pursue
aggressively. The goal is
to reduce the number of
counterfeits produced in
China as well as to raise
public awareness to the
threats that these
products pose to health
and safety. In December
2003, Pfizer provided Not only is the chemical composition of counterfeit
training to the Shanghai medicines more sophisticated but so also is the labeling
regulatory authorities and other packaging which can easily mislead patients.
to enhance their ability This photograph shows the labeling of an authentic versus
to distinguish between a counterfeit label.
counterfeit Pfizer The counterfeit bottle (left) is from Viagra dispensed from a
products and to share pharmacy in Glendale, California. Although the counterfeit
with them investigative packaging closely resembles the authentic, there were several
techniques that had areas in which the type was excessively bold. The Pfizer
proved effective in logo was poorly rendered and the field behind the tablet
previous investigations. strength is more pointed than on the authentic.
myth #4: IT’S EASY TO TELL THE DIFFERENCE
BETWEEN COUNTERFEIT MEDICINES
AND AUTHENTIC MEDICINES.
Technology to produce everything from labels to active pharmaceutical
ingredients is now widely available. With growing technological
sophistication, counterfeiters are often able to make fake medicines look
almost identical to authentic ones.
Consumers may not even know that the medicines they've purchased are
counterfeits. In dealing with counterfeit cases, Pfizer is sometimes made
aware of problems when a patient reports a different taste, or appearance
of a medicine that is later identified as being counterfeit. In worst cases,
patients may have an adverse medical reaction to the counterfeit drug.
That's why it's important for patients to purchase prescription medicines
from a pharmacy and pharmacist with whom they are familiar.
This site for the manufacture of counterfeit
Ponstan was raided by authorities in
Colombia. Authorities seized large quantities
of counterfeit Ponstan (left), packaging and
The counterfeit tablets manufactured in this
plant may appear harmless, but they
contained none of the active ingredient
found in authentic Ponstan. Instead, they
were composed primarily of boric acid, a
pesticide that can, when ingested, cause
gastrointestinal symptoms and renal failure.
Some of the counterfeit Ponstan examined
in an earlier case actually achieved its yellow
color from leaded highway paint!
EXPORTS AND IMPORTS
Export/Import patterns suggest Canada is importing pharmaceuticals from non-U.S.
sources to meet increased demand from Americans seeking “Canadian” medicines.
According to the Center
for Pharmacoeconomic TRIPLE-DIGIT GROWTH FOR PHARMACEUTICAL
Studies at the University
EXPORTS TO CANADA FROM VARIOUS COUNTRIES
of Texas at Austin,
Imports to Canada for Pharmaceutical Products, Annual Totals
Canada is importing
from Selected Countries in Percentage Growth, 2002–2003
more medicines from
around the world. Since 327% 309%
1999, Canada has total
pharmaceutical imports 182%
by Canada have increased 143% 137% 134%
101.6% from $2.347
billion to $4.732 billion. 19%
Iran Bulgaria Panama South Swaziland Malta Thailand US
These imported Korea
medicines are not going 2003: $211,708 $107,594 $244,150 $1,792,355 $149,526 $609,810 $1,416,379 $3 billion
to meet the needs of 2002: $49,524 $26,324 $86,723 $737,576 $63,195 $261,028 $933,725 $2.5 billion
Canadians. A growing Source: Trade Data Online, NAICS Codes. Strategis.gc.ca, Extracted March 2004
portion of these imported
medicines is being used for export out of Canada. This chart graphically depicts the
shift in the proportion of Canadian drug imports from the U.S. and other
countries. Among the countries exporting more medicines to Canada is Iran.
Source: Center for Pharmacoeconomic Studies, University of Texas at Austin, Report to Senate
Permanent Select Committee on Investigations, 2004
myth NOT A:COUA MEDICINE THEAUTHENMEDICINE
#5 IF NTERFEIT), IS N THE TIC
CAN AUTOMATICALLY BE ASSUMED TO BE SAFE.
Unfortunately, counterfeiting is only one aspect of the criminal activity
involving medicines. “Diversion” of authentic medicines is also a growing
problem that poses potential risks to the American supply of medicines.
Diversion refers to medicines that are “diverted” – often illegally – from their
intended markets. This is sometimes referred to as the “gray market.”
Numerous criminal investigations have revealed the close ties between diverted
and counterfeited medicines. In the Lipitor® counterfeiting case, the FDA
found a commingling of authentic and counterfeit tablets.
myth #6: EXISTING LAWS ARE EFFECTIVE IN
THE PREVENTION OF COUNTERFEITING.
Counterfeiting is a global problem, and counterfeit operators around the
world (whether they be manufacturers, packagers, distributors or
middlemen) have a keen interest in penetrating the U.S. market.
The importation of counterfeit, infringing, misbranded and unapproved
pharmaceutical products into the United States is on the rise.
The response by regulatory and law enforcement agencies to the growing crisis
must be reviewed, analyzed and modified at all levels. The public health and
safety depend upon the FDA's vigilance. The safety of the U.S. supply of
pharmaceuticals hangs in the balance.
Given the recent rise in the number of counterfeiting cases, it cannot be said
that existing strict regulations are sufficient to prevent counterfeiting. Regulations
governing the drug distribution system do not provide a strong enough deterrent,
in terms of enforcement and penalties, to discourage counterfeiters.
LIPITOR® REPACKAGING IN LOS ANGELES
A California company came under scrutiny in 2002 for repackaging
medicines intended for foreign markets and selling those medicines in the
U.S. In 2003, bottles of Lipitor repackaged by this same company were
found to contain counterfeit tablets.
An investigation, conducted by the FDA and the Los Angeles County
Sheriff ’s Office, found several illegal schemes where authentic Pfizer
medicines – intended for foreign markets – were imported into the U.S.,
repackaged, and then sold in the U.S. (The emptied medicine bottles
and packaging – with the foreign language labels – were then filled
with vitamins and other inappropriate substances and shipped to a
hospital in Vietnam.)
The principal Pfizer product being repackaged was Lipitor®, obtained
primarily from Canada. When search warrants were executed at those
firms in February 2003, authorities seized large quantities of Pfizer
products, including Lipitor®.
While some of those medicines were still in their original packaging,
others were in plastic sandwich bags, with handwritten notes identifying
the product, lot number and expiration date. Even though diverted
medicines may be authentic, they may still pose a risk to patients because
the manner in which they have been handled and stored cannot be
determined. Lipitor®, for example, is highly sensitive to humidity.
Authentic Pfizer packaging for Lipitor® has been designed to protect the
product from humidity and ensure its efficacy. No such assurances can be
provided once the product is removed from the carefully designed Pfizer
packaging and placed into plastic bags.
TO PRESERVE THE INTEGRITY
OF THE U.S. MEDICINE SUPPLY
WHAT NEEDS TO BE DONE
Pfizer recommends the following steps be taken to help Americans avoid
the dangers of counterfeit medicines.
• Require more transparency in, and tighter • Permit the FDA to conduct unannounced
control over, the flow of pharmaceuticals in inspections so as to ensure compliance with
the distribution process. When medicines FDA regulations. The giving of notice, which
start flowing between multiple wholesalers is now required, permits those engaged in
before arriving at the pharmacy, oversight criminal behavior, those placing the public
becomes tougher. health and safety at risk, to conceal the
evidence of their conduct.
• Require pedigrees for all medicines that have
more than one pharmacy or wholesaler in • Enhance criminal and civil penalties for
their chain of sale. Implement and enforce the counterfeiting medicines. As long as the
“pedigree” provisions of the Prescription Drug counterfeiting of medicines remains a high-
Marketing Act (PDMA) of 1988. These profit, low-risk criminal activity, it will
provisions require wholesalers to provide their continue to attract organized crime and
customers with a pedigree documenting the terrorist organizations.
sales history of the medicines they sell. For
• Encourage new state regulations for wholesaler
years, these requirements have been delayed in
legal and regulatory challenges.
• Provide additional resources to the FDA and
• Improve regulatory scrutiny of “repackagers.”
Customs Service so that they may fulfill their
The repackaging of pharmaceuticals can easily
mandate to protect the American public.
result in the introduction of counterfeit and
unapproved products into legitimate distribution • Provide funding to the States for the sole
channels. Repackagers must come under more purpose of ensuring the integrity of the
careful scrutiny by the FDA. Regulations that distribution system through inspections
apply to these firms must be strictly enforced and oversight.
and, where necessary, additional regulations • Finally, oppose importation legislation which
enacted. Particular scrutiny of those engaged in would only exacerbate the current situation
import for export is required. and create vast new opportunities for
• Improve FDA’s recall procedures by giving the counterfeiters to penetrate the U.S. market.
FDA authority to compel a recall. When the Defend the landmark Prescription Drug
manufacturer provides evidence of counterfeiting, Marketing Act, written under the
the FDA should have the resources and the stewardship of U.S. Rep. John Dingell,
authority to act on that information. passed by Congress in 1987 and signed by
President Ronald Reagan in 1989.
WHAT IS PFIZER DOING TO COMBAT
THE COUNTERFEITING PROBLEM?
• Pfizer has built a team of global security others globally to determine how to best keep
professionals who investigate counterfeiting the drug distribution system safe for patients.
cases around the world. The company works
• Pfizer continues to explore and implement
with law enforcement authorities in each
new technological developments to deter
country as well as multilateral organizations
counterfeiting. Pfizer uses special packaging
to help stem the flow of counterfeits.
and printing techniques that make
• Pfizer has developed effective partnerships with counterfeiting both more difficult to
regulatory agencies around the world. We are accomplish and easier to spot.
working with wholesalers, the pharmacy
• Pfizer is working with the FDA, wholesalers,
community, and all regulatory and law
the pharmacy community and others to
enforcement agencies, such as the FDA, the
determine how to best keep America's drug
British Medicines and Health care products
distribution system safe for patients.
Regulatory Agency (MHRA), the Australian
Therapeutic Goods Administration (TGA), and
HOW CAN YOU AVOID BUYING COUNTERFEIT PRODUCTS?
• The best way to avoid counterfeit drugs is to • Closely scrutinize the appearance of your
purchase prescription medicines at your local medicine and its packaging. Talk to your
pharmacy from a reputable pharmacist whom pharmacist if you notice anything unusual, or if
you know. you have a different reaction to your medicine.
• Where available, ask for the product in the • Report suspected counterfeiting to the FDA
manufacturer's original package. MedWatch Program (or 800-FDA-1088) and
to the manufacturer.
• Avoid drugs in foreign packaging because
unregulated imports have been a way for • Remember that if the price of a medicine
counterfeits to enter the U.S. market. seems too good to be true, it probably is.
BUYING MEDICINES ONLINE
• Before you fill your prescription online, – Through certification of pharmacies that meet
always see your doctor and get a written state licensing and inspection requirements,
prescription. the NABP helps ensure the quality and safety
of every online prescription.
• Use an online pharmacy certified by the
National Association of Boards of Pharmacy • Don't buy medications from an online
(NABP) through its “Verified Internet pharmacy that isn’t licensed in your country,
Pharmacy Practice Sites” (VIPPS™) program. that offers to write prescriptions, or that sells
medications without prescriptions.
– Use the VIPPS™ certified pharmacy list to
choose a VIPPS™-approved online pharmacy.
“We have found that some patients who
believe they are purchasing re-imported
Canadian medicines are in fact receiving non-
FDA approved drugs from foreign countries
that are not at all what they claim to be.
There is significant evidence that patients
have received drugs through the internet that
are past their expiration date, are sub-potent
(or, in some cases, more potent than indicated), contain the wrong
dose, are contaminated or clearly counterfeited, are not properly
stored or shipped (i.e. medicines that require constant refrigeration
or others that must be protected from freezing) among other
problems. We have found that medicines ordered over the internet
that purport to be manufactured under FDA oversight or delivered
through Canadian pharmacies are in fact manufactured in countries
such as Pakistan, China, Iran, Singapore and many others. The
fundamental question of product quality and integrity must be at
the center of this important discussion.”
Mayor Rudolph W. Giuliani
Former Mayor of New York City
Quoted in a report delivered to the Senate Government Affairs Permanent Subcommittee on Investigations
June 17, 2004
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