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FDA
Announces Initiative to Heighten Battle Against Counterfeit Drugs
July 16, 2003 -
Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., today
announced a major new initiative to more aggressively protect American
consumers from drugs that have been counterfeited. The new initiative
includes creating an internal task force to explore the use of modern
technologies and other measures such as stronger enforcement that will
make it more difficult for counterfeit drugs to get distributed with -
or deliberately substituted for -- safe and effective drugs.
The task force will submit
its initial findings and recommendations in approximately 60 days and
will issue a final report six months from now, after opportunities to
hear from the public. In addition, FDA plans to coordinate more
closely with other federal agencies and state and local governments
that share the responsibilities with FDA for ensuring the safety of
the U.S. drug supply and distribution system as well as with members
of Congress who have worked closely with FDA in the past on these
important public health issues.
“It’s essential for
consumers that the medicines that they buy are the actual drugs that
their doctors prescribe,” said Secretary of Health and Human Services
Tommy G. Thompson. ”The dangers of counterfeit drugs are real, and we
must protect consumers from these dangerous frauds. We will
aggressively investigate instances of drug counterfeiting and will
seek criminal prosecution of all offenders to the fullest extent of
the law.”
Counterfeit prescription
drugs are not only illegal but are also inherently unsafe. Many
counterfeit drugs are visually indistinguishable from the authentic
versions, and thus pose a potentially serious health threat to
Americans. Consumers can protect themselves from counterfeit drugs by
purchasing their medications from licensed, domestic pharmacies and
contacting their pharmacist or doctor if they notice anything unusual
about their medication --including its packaging, taste, or unfamiliar
side effects such as an unfamiliar feeling at an injection site.
“The sole purpose of this
initiative is to develop new and innovative ways to make sure that
Americans can continue to have confidence that the drugs they buy are,
in fact, the real deal,” said Commissioner McClellan. “There are new
technologies and new opportunities for counterfeit drugs to reach
Americans, but there are also new technologies and opportunities for
FDA to protect the integrity of our drug supply. One thing isn’t
changing: counterfeiting - and counterfeiters - have no role to play
in the American health care system.”
In the United States, drug
counterfeiting is a relatively rare event. Although FDA believes
domestic counterfeiting is not widespread, the agency has recently
seen an increase in counterfeiting activities as well as a more
sophisticated ability to introduce finished dosage counterfeits into
the otherwise legitimate drug distribution channels. FDA has likewise
seen its counterfeit drug investigations increase to over 20 per year
since 2000, after averaging only about 5 per year through the late
1990’s.
At the same time, worldwide
counterfeiting of drugs is believed to be more commonplace. The World
Health Organization has estimated that perhaps seven or eight percent
of drugs worldwide are counterfeit, and reports from some countries
suggest that as much as one-half of those countries’ drugs are
counterfeit.
The FDA initiative is
designed to better identify the risks and threats from counterfeit
drugs, to coordinate public and private efforts to fight drug
counterfeiting and distribution, and to develop new tools to aid in
identifying, deterring and combating counterfeiting.
Specifically, the internal
FDA task force will:
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Develop a strategic
action plan to decrease the risk of counterfeit drugs entering the
U.S. marketplace and to protect consumers from potentially harmful
effects of using these products.
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Continue to strengthen
FDA’s collaborative relationships with other federal agencies,
including the Bureau of Immigration and Customs Enforcement (BICE),
the Bureau of Customs and Border Protection (BCBP), and the U.S.
Secret Service in the Department of Homeland Security and entities
within
the Department of Justice, as well as with health professionals,
industry, consumer, and other stakeholders to gather information
regarding the best practices for dealing with drug counterfeiting.
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Identify mechanisms for
strengthening the nation’s protections against counterfeiting,
including such possibilities as model practice acts for adoption by
the states, best practices for those who sell and distribute
prescription drugs, and better education for patients, pharmacists,
and others about how to identify counterfeit drugs and alert others
to their existence.
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Assess the extent to
which new technologies, e.g., counterfeit-resistant packaging,
product identifiers such as chemical taggants, and implanted
radio-frequency chips in packaging can help assure the authenticity
of drugs. Although some of this technology is not currently mature
enough to adequately protect the drug supply, it may have great
promise as an added counter-measure against counterfeit
pharmaceutical products.
FDA believes the increase
and shift in this illicit activity has occurred for a number of
reasons. These include:
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better counterfeiting
technology, including improved technology to make labeling,
packaging
and products that appear real but are not;
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better organized, more
effective criminal groups attracted by financial opportunities;
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the online sale of
prescription drugs by unlicensed pharmacies and/or foreign websites;
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opportunities for
introducing foreign-made counterfeit and unapproved drugs into large
and rapidly growing import flows; and
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weak spots in the
domestic wholesale drug distribution chain, including some
wholesalers who acquire most of their inventory from secondary
sources, do not maintain effective due diligence efforts on these
sources and ignore warning signs indicative of illegal or unethical
behavior.
“At the forefront of this
effort will be the special agents of our Office of Criminal
Investigations (OCI). Their record and dedication is impressive.
Working together, I am confident we will defeat the criminal element
engaged in counterfeit drug activity,” added Commissioner McClellan.
For example, OCI has
recently launched a major counterfeit investigation relating to
Lipitor, a widely prescribed cholesterol-lowering drug, and three
convictions that occurred as a result of their investigation of
counterfeited Procrit, a drug used to stimulate the production of red
blood cells to treat severe anemia.
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