**Testimony of**

**Carmen A. Catizone, MS, RPh, DPh**

**Executive Director/Secretary**

**National Association of Boards of Pharmacy**

**Testimony before the Secretary's Task Force on Importation**

**Chairman, Richard H. Carmona, M.D., M.P.H., F.A.C.S.**

**United States Surgeon General**

**May 14, 2004**

Mr. Chairman and Members of the Task Force:

I am honored to submit the following information on the illegal
importation of drugs into the United States and its impact on the public
safety and state regulation of the practice of pharmacy.

The National Association of Boards of Pharmacy (NABP) was founded in
1904. Our members are the pharmacy regulatory and licensing
jurisdictions in the United States, District of Columbia, Guam, Puerto
Rico, and the Virgin Islands, eight provinces of Canada, three
Australian States, New Zealand, and South Africa. Our purpose is to
serve as the independent, international, and impartial Association that
assists states and provinces in developing, implementing, and enforcing
uniform standards for the purpose of protecting the public health.

NABP does not oppose importation within the safe and secure regulatory
framework of the Food and Drug Administration (FDA) and state boards of
pharmacy. NABP does oppose the illegal importation of medications which
is presently occurring and compromising the integrity of our medication
system and state regulation of the practice of pharmacy. At our recently
concluded Annual Meeting, which marked the 100^th^ Anniversary of the
founding of NABP, the member boards passed a resolution which resolved:

*That NABP continue to oppose the illegal importation of medications and
express to the Food and Drug Administration (FDA) the concerns of its
member boards and strongly urge the FDA or appropriate legal authority
to pursue actions against state and local governments for endorsing,
promoting, or engaging in the illegal importation of medications.*

**Illegal Importation is a Real Threat to the Public Health and Safety**

The illegal importation of drugs from Canada and other countries is one
of the most complicated and frustrating issues confronting pharmacy
regulators. It is an issue that has the potential of altering how
medications are dispensed in the United States and how the practice of
pharmacy is regulated. In fact, if the illegal importation of drugs into
the US is allowed to continue, the impact on patient safety, pharmacy
practice, and the regulation of pharmacy practice will be devastating.
Patients illegally importing drugs are bypassing the drug approval
process of the Food and Drug Administration (FDA) and the safety of
licensed US pharmacies thus placing their health and well being in the
hands of the country, territory, or back room with the seemingly, lowest
prices for pharmaceuticals.

At its worst, the illegal importation of drugs creates the opportunity
for unknowing and unsuspecting patients to suffer harm, counterfeit and
dangerous drugs to contaminate the US medication distribution system,
and a thalidomide-like disaster to reoccur.

When the patient safety concerns of state boards of pharmacy, the FDA,
and other regulatory agencies are ignored by patients, governors,
mayors, and legislators with a chilling, "If the illegal importation of
drugs is unsafe, then show us the bodies!" the situation becomes even
more compelling. NABP cannot accept the premise that people must die
from the illegal importation of drugs before the existing laws ensuring
the safety of patients are complied with and enforced. The "show us the
bodies" strategy proposed by some legislators, governors, mayors, and
other public officials is irresponsible.

Critics of the regulatory actions of the FDA and state boards of
pharmacy against entities distributing or assisting in the distribution
of medications from other countries contend that there have been only a
few reports of patient harm and injury. Although the number of reports
may be low, the actual harm to patients is immeasurable and could be
significant. NABP maintains that the number of reported patient injuries
is low and immeasurable because patients may not be able to discern
whether the drugs received from other countries are authentic or
appropriate, injuries resulting from patients receiving wrong or
counterfeit drugs may not manifest in the health care system until
sometime later when the patient's condition worsens and requires
emergency treatment or hospitalization, and consumers purchasing drugs
from other countries are reluctant to report any adverse consequences
because of the fear of prosecution for violating federal and state laws.

NABP's response to critics of the actions of the state boards of
pharmacy to enforce existing state and federal laws protecting the
public and prohibiting illegal importation is the presentation of
reports from consumers describing real problems which are occurring with
illegal importation. Some of the incidents reported to NABP include:

-   An Oregon patient being treated for breast cancer receiving the
    wrong medication from a Canadian pharmacy. The patient continued to
    take the wrong drug for three months as her condition worsened.

-   Consumer complaints, totaling thousands of dollars, reporting that
    payment was made (credit cards charged) and no product received.

-   Consumer complaints of counterfeit or inactive products:

    -   *Ordered Acyclovir 400MG from this site received some other
        medication. Verified using imprint codes.*

    -   *Product has no effect. Seems counterfeit.*

    -   *The pills have no obvious effect.*

    -   *I have taken pain medication before (prescribed by a local
        doctor). The effects of such meds are obvious. For one thing,
        the taste is bitter, bordering on awful. In contrast, the pills
        from MedPrescribe have no taste (I split one in half and tasted
        it). More importantly, the MedPrescibe pills have no effect (no
        benefit). In short, they do nothing to alleviate my pain.
        Nothing.*

    -   *The item I received was very close to the shape and size of
        genuine Viagra. However, they bore no marking, logo, or
        insignia. Also the surface of the tablet was not as smooth and
        polished as real Viagra. The tablets were received sealed inside
        of a foil pouch with no indication of origin.*

    -   *Order arrived with pills in a zip lock bag with drug name and
        dose on an adhesive label stuck on the bag. No return address on
        the mailing envelope and no receipt in the envelope.*

    -   *I ordered \"Tramadol\" from this site, but what I received was
        not Tramadol. I contacted the poison control center, and they
        stated that they did not know what this medication was, nor did
        any local pharmacy know. I called \[the site's\] customer
        service number but they would not let me speak to the pharmacist
        that filled the script.*

-   Consumer complaints regarding illegal and life-threatening access to
    addicting drugs,

    -   *My wife is ordering drugs such as phendimetrazine and clonopin
        over the internet. They arrive by FedEx. Her charge card is
        charged because she gave the pharmacies her info. The pharmacies
        have some unknown drugs.*

    -   *The header read, Vicodin, 24 Hour Sale Online - looks to be
        aimed at drug addicts. My son is a prescription drug addict
        (currently non-using), so the potential is very high.*

One of the most startling examples of the atrocities of illegal
importation drugs is the receipt of drugs wrapped in tin foil void of
any labeling, product identification, directions for use, warning
labels, or protective container.

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> height="2.183333333333333in"}
>
> ![](media/image2.png){width="3.4833333333333334in"
> height="2.0833333333333335in"}

NABP has also learned that the purchase and import of drugs from other
countries is gravely compromising state laws and regulations by granting
the authority to practice medicine and prescribe medications to
unqualified, unlicensed individuals and fueling the proliferation of
solicitations for controlled substances:

-   A US entity affiliated with a Canadian pharmacy operation is paying
    paramedics in the US to conduct the physical examination and
    diagnosis of patients. The paramedics' examinations and diagnosis
    are then forwarded to a Canadian pharmacy where prescriptions are
    issued by a Canadian doctor and drugs shipped to US patients. This
    activity contravenes US laws by allowing paramedics to practice
    medicine without appropriate education, training, and licensure.

-   A certification/purchasing program is providing the means for
    psychologists to illegally order psychotropic drugs (e.g.
    barbiturates, Clozapine, haloperidol, etc.) for their patients
    through a Canadian pharmacy. Again, the opportunity to obtain
    prescription medications through foreign sources is directly
    abrogating the US regulatory system and allowing individuals to
    practice medicine without the appropriate education, training, and
    licensure.

-   Within the last four months NABP identified a staggering number of
    web sites brazenly offering controlled substances without a valid
    prescription (as required by federal and state laws) and a never
    before witnessed preponderance of spam emails offering unrestricted
    and illegal access to controlled substances.

**Importation Places Patients Outside of Regulatory Safeguards**

NABP acknowledges that appropriate safeguards exist within Canada's
federal and provincial regulatory systems to ensure that the dispensing
of medications in Canada to Canadian patients is safe. Similarly, NABP
attests that the dispensing of medications to US patients within the US
regulated system is safe.

Unfortunately, the same safeguards do not exist for US patients
purchasing and importing drugs from Canada and other countries.
Information received by NABP indicates that although Health Canada
prohibits the import of drugs outside of the Canadian approval system
for dispensing to Canadian patients, it does not prohibit or regulate
the import of such drugs for export to US patients. The regulatory void
and breach of the safety net for US patients is significant and unknown
to the overwhelming majority of patients ordering drugs from Canadian,
or believed to be Canadian, pharmacies. NABP learned first-hand from the
president of an Internet pharmacy corporation based in Canada that drugs
shipped to US patients may not be approved by the Canadian drug approval
process and may originate in New Zealand, Vietnam, Pakistan or any
country in the world where prescription drug prices are lower than those
in the US or Canada.

In fact, there are no limitations as to where drugs will originate from
for delivery to US patients. Recent media reports indicate that the
State of Illinois will be sending a team to visit sites in Europe with
the desired outcome of allowing for the shipment of drugs to Illinois
citizens from European countries. Although NABP has information
regarding the drug approval process and provincial regulatory system in
Canada, related information from countries in Europe and other parts of
the world is extremely limited. Each progression to extend the
distribution source to unknown borders further away from the FDA drug
approval process and state regulation of pharmacy practice makes the
situation more dangerous. The extension of importation to countries
lacking effective drug approval processes, regulatory systems, or
practice standards, the further the erosion and destruction of the
entire regulatory structure for the practice of pharmacy. The US system,
based within the states and the FDA, has been exemplary in protecting
the citizens of the various states and providing patients and health
care practitioners with the assurances and confidence that the
medications prescribed and dispensed are safe and effective products.
The state based regulatory system successfully protects patients and is
flexible enough to extend the regulatory framework and safety net across
state borders and allow for the practices of telepharmacy and
telemedicine to become realities.

The keys to this interstate regulatory framework have been uniform
practice standards, licensure of pharmacists and pharmacies, and
licensure or registration of non-resident pharmacies. In fact, all but a
handful of states require that non-resident or out of state pharmacies
license or register with them and comply with their applicable laws and
statutes. These laws and regulations have been in place in some states
for almost 20 years, effectively protecting the citizens of the states
and fostering cooperation among the states. The nonresident pharmacy
laws and regulations protect the practices of pharmacy and medicine
across state lines without unduly burdening interstate commerce and
rightfully restricting the operation of illegal operations seeking to
bypass the regulatory system of the states. State laws and regulations
also allow for Internet pharmacies, the electronic transmission of
prescriptions, shared data bases, electronic patient profiles, and other
means for patients to receive pharmacist care and appropriately
prescribed medications across state lines, through the Internet, or by
the use of the mail. These laws and regulations transfer existing and
accepted standards for patient care from traditional brick and mortar
pharmacies to new, non-traditional Internet pharmacies and interstate
practices. In order for importation to occur safely and appropriately,
the same regulatory framework and safeguards must be in place across the
borders of the US.

If the appropriate inter-border regulatory framework is not in place,
then allowing for the purchase and import of drugs from pharmacies or
foreign operations that do not comply with existing federal and state
laws and regulations places US patients at risk. If the safeguards in
place for the US drug approval system and state regulation of pharmacies
and wholesale distributors are deliberately compromised, US patients
will be subject to the dangers of a "buyers beware" environment and left
unprotected to gamble with their health and safety.

**Inter-border Regulatory Proposal**

NABP recognizes that a solution resolving the conflict of affordable
access to medications versus safety concerns must be developed to
address the needs of US patients and prevent irreparable damage to, if
not the elimination of, the regulatory systems in the US. The first step
of this process was the launching of the VIPPS program in Canada in
November 2003 by NABP and the National Association of Pharmacy
Regulatory Authorities (NAPRA) in Canada. The VIPPS Canada program
mirrors NABP's VIPPS program[^1] in the US and will identify for
Canadian patients legal and safe Internet pharmacies accredited by a
credible and valid system with standards that focus on the protection of
the public health and patient safety.

NABP is also in discussions with a variety of regulatory agencies and
affected stakeholders to develop the necessary regulatory framework to
regulate the inter-border practice of pharmacy and dispensing of
medications to patients in the US and Canada. The framework would
provide similar protections as those afforded US patients who utilize
pharmacies engaged in the interstate practice of pharmacy and would
focus on identifying and monitoring the source of medications. The
framework will coordinate the regulatory efforts and resources of the
Canadian provinces and US state boards of pharmacy.

In closing, NABP respectfully requests that the Task Force recognize
that allowing and encouraging the purchase and importation of
medications from other countries without the appropriate regulatory
safeguards is a serious threat to our regulatory foundation and patient
safety. NABP requests further, the Task Force's assistance in preserving
the sanctity of current regulations so as to prevent any patient from
being seriously injured by the illegal importation of medications from
other countries where US laws and regulations are being ignored or the
laws of that country or territory do not equate to US laws and
regulations. NABP does not believe that even one patient should suffer
or be harmed as a consequence of disregarding federal and state laws
that ensure the dispensing of safe and effective medications to US
patients.

Thank you for the opportunity to address this important issue.

[^1]: NABP's VIPPS program was introduced by NABP in 1999 and fashions
    traditional regulation and consumer empowerment into a thorough and
    successful verification and authentication system. The VIPPS process
    developed by NABP encompasses compliance with state and federal laws
    governing the practice of pharmacy and the direct verification of
    licensure of the Internet pharmacy with all states where licensure
    or registration is required. VIPPS certifies, through on-site
    inspections and the meticulous analysis of the site's operations and
    submitted written information, compliance with an 18-point
    criterion. The VIPPS Criteria combine current licensure requirements
    in all of the US states and territories with additional criterion
    that concentrate on the distinctions of Internet practice such as
    the transmission of prescription information and patient data,
    confidentiality of patient records, and quality improvement and
    monitoring of prescription processing and patient interactions.