FDA Warning Letter – Global Drug Supply

TO: Global Drug Supply
FROM: The United States Food and Drug Administration
RE: Shipment of Unapproved New Drugs and Misbranded Drugs to the United
States
DATE: December 6th, 2016
WARNING LETTER
The United States Food and Drug Administration (FDA) has determined that your firm
causes the introduction of unapproved new drugs and misbranded drugs into the United
States (U.S.) by shipping to U.S. consumers in violation of sections 301(a), 301(d), and
505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a),
331(d), and 355(a)]. FDA requests that Global Drug Supply immediately cease shipping
violative drug products to U.S. consumers.
UNAPPROVED NEW DRUGS
Global Drug Supply dispenses and ships unapproved new drugs directly to individual
U.S. consumers on behalf of Canadadrugs.com, an internet pharmacy from which U.S.
consumers purchase violative drug products.1
The drug products shipped by Global Drug
Supply are represented as being equivalent to U.S. approved drug products that are
indicated to treat serious conditions including (but not limited to) seizures, Parkinson’s,
hypertension, depression, and asthma. Because these products are intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect
the structure or function of the body, these products are drugs within the meaning of
section 201(g) of the FD&C Act [21 U.S.C. § 321(g)]. These products are also new
drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they
are not generally recognized as safe and effective for their labeled uses. New drugs may
not be legally introduced or delivered for introduction into interstate commerce without
prior approval from FDA as described in section 505(a) of the FD&C Act [21 U.S.C. §
355(a)]. No approved applications pursuant to section 505 of the FD&C Act [21 U.S.C.
§ 355] are in effect for these products. Accordingly, their introduction or delivery for
introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C
Act [21 U.S.C. §§ 331(d) and 355(a)].

1
Canadadrugs.com and Global Drug Supply are both under criminal indictment in the U.S. District Court
for the District of Montana for engaging in the illegal importation of unapproved new drugs, misbranded
drugs, and counterfeit drugs for sale and distribution to physicians and physician office practices in the U.S.
(The charges contained in the Indictments are merely accusations and the defendants are presumed
innocent unless and until proven guilty.)
Canadadrugs.com received an FDA Warning Letter in 2012 for causing the introduction of misbranded and
unapproved drugs into the U.S. See
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm321068.htm.
Page 2
FDA physically examined packages imported to the U.S. by Global Drug Supply that
were determined, based on shipping labels, prescription order forms, and product labeling
to contain unapproved new drugs.
One example of an unapproved new drug shipped by Global Drug Supply to a U.S.
consumer is Pristiq. While Pristiq is the name of an FDA-approved prescription drug, the
product labeling for the drug shipped to the U.S. from Global Drug Supply is intended for
Australia. For example, the product labeling states, “Pfizer Australia Pty Ltd” and refers
to medical information available at “Australia 1800 675 229” and
“medicalaffairs.anzpfizer.com.” In the U.S., Pristiq is approved for the treatment of
depression. Shipping an unapproved version of this drug to U.S. consumers is particularly
concerning given that FDA-approved Pristiq bears a boxed warning, commonly referred
to as a “black box warning,” which is the strongest warning FDA requires, indicating that
the drug carries a significant risk of serious or even life-threatening adverse effects. The
boxed warning addresses suicidal thoughts or actions. There have also been reports of
several serious adverse reactions associated with the use of Pristiq such as a potentially
life-threatening condition called serotonin syndrome that can happen when Pristiq is
taken with certain other medicines. Serotonin syndrome can cause serious changes in
how the brain, muscles, heart and blood vessels, and digestive system work. In addition,
Pristiq can cause other serious side effects such as new or worsened high blood pressure,
abnormal bleeding or bruising, and visual problems.
Another example of an unapproved new drug shipped by Global Drug Supply to a U.S.
consumer is Exforge. While Exforge is the name of an FDA-approved prescription drug
indicated for the treatment of high blood pressure, the product labeling for the drug
shipped to the U.S. from Global Drug Supply states that it is distributed in Australia.
Shipping an unapproved version of Exforge to U.S. consumers is especially concerning
given that FDA-approved Exforge bears a boxed warning regarding harm or death to an
unborn baby. Exforge product shipped to the U.S. by Global Drug Supply contains no
such boxed warning. In addition, the FDA-approved product labeling for Exforge
includes warnings and precautions regarding low blood pressure, risk of heart attack or
worsening chest pain, decreased kidney function, and increased potassium levels in the
blood. There have been reports of several adverse reactions associated with the use of
Exforge including, but not limited to, swelling of the hands, ankles, or feet, nasal
congestion or sore throat, head or chest cold, and dizziness.
MISBRANDED DRUGS:
Because drugs shipped by Global Drug Supply appear to be manufactured and marketed
for countries other than the U.S., they are unapproved new drugs under the FD&C Act, as
described above. A drug is misbranded under section 502(f)(1) of the FD&C Act [21
U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s).
“Adequate directions for use” means directions under which a layperson can use a drug
safely and for the purposes for which it is intended (21 CFR 201.5). The drug products
shipped by Global Drug Supply purport to treat conditions that are not amenable to selfdiagnosis
and treatment by persons who are not medical practitioners. Therefore,
adequate directions for use cannot be written for these drug products, and they must
qualify for one of the exemptions to 502(f)(1) to avoid being misbranded The exemption
Page 3
to 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] found at 21 CFR § 201.100 does
not apply to unapproved new drugs because that exemption requires that such drugs bear
“the labeling authorized by the approved new drug application.” Furthermore,
unapproved new prescription drugs also do not qualify for the exemption set forth at 21
CFR 201.115, which also requires an approved new drug application (NDA) or active
investigational new drug application (IND). Consequently, a prescription drug that is a
new drug and has not been approved by FDA or is not subject to an exemption from the
premarketing approval requirements under the FD&C Act cannot qualify for the
exemptions to 502(f)(1). Because none of the exemptions to 502(f)(1) apply, the labeling
for the drug products shipped by Global Drug Supply fails to bear adequate directions for
the intended uses, and the products are therefore misbranded under section 502(f)(1) of
the FD&C Act [21 U.S.C. § 352(f)(1)]. By shipping these products to U.S. consumers,
Global Drug Supply is causing the introduction of misbranded drugs into interstate
commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Additional examples of misbranded and unapproved new drugs that have been shipped by
Global Drug Supply to U.S. consumers are noted in the table below.* This list may not be
all-inclusive.
Generic Name Brand Name
Budesonide/formoterol    Vannair
Bupropion Zyban
Celecoxib Celebrex
Conjugated Estrogen Premarin
Estrogens, Conjugated/Medroxyprogesterone Premia
Duloxetine Cymbalta
Escitalopram Lexapro
Estradiol Estradot
Estradiol/Norethindrone Estalis
Ezetimibe Ezetrol
Fexofenadine Telfast
Finasteride Regen
Fluticasone Flixotide
Fluticasone/Salmeterol Seretide
Hydroxychloroquine Plaquenil
Metoprolol CR Betaloc CR
Pentosan Elmiron
Phenytoin Dilantin
Pramipexole Sifrol
Rosuvastatin Crestor
Salbutamol/Ipratropium Duolin
Sildenafil Viagra
Tazarotene Zorac
Telmisartan/Hydrochlrothiazide Micardis Plus
Tretinoin Retrieve
Valsartan/Hydrochlorothiazide Co-Diovan
*Several of the accompanying labels purport that the shipped drug is equivalent to an FDA-approved drug.
Page 4
CONCLUSION:
FDA is taking this action against Global Drug Supply because of the risks posed by its
conduct in causing the importation of drugs that are unapproved and misbranded into the
U.S. FDA’s regulation and oversight of the drug approval process protects consumers by
requiring rigorous scientific standards for new drug approval, labeling review for
accuracy and completeness, and manufacturing procedures and testing performed under
closely controlled conditions at FDA-registered and inspected facilities.
Unapproved foreign versions of FDA-approved drugs often have different trade names or
manufacturers and may have substantially different risk profiles due to changes in drug
formulations, drug delivery methods, directions for use, or contraindications and
warnings. Any and all of these factors may harm consumers who are unaware that they
are not receiving the same medications prescribed by their healthcare practitioners.
Taking an unapproved drug in place of the FDA-approved product can negatively affect
patient outcomes because the health care practitioner may unknowingly make subsequent
treatment decisions based on the patient’s response to the unapproved drug, rather than to
the approved drug that was prescribed. This can also cause potentially dangerous drug
interactions with the patient’s other medications.
This letter is not intended to identify all the ways in which your activities might be in
violation of law. You should promptly cease shipping misbranded and unapproved new
drug products to U.S. consumers and correct any other violations of the FD&C Act.
Failure to do so immediately may result in further regulatory action, including seizure or
injunction, without further notice.
Please notify this office in writing within 10 working days of receipt of this letter of any
steps you have taken or will take to correct the violations set forth above and to prevent
their recurrence. If the corrective action(s) cannot be completed within 10 working days,
state the reason for the delay and the time within which the correction(s) will be
completed. Your response, and any other inquiries concerning this letter, should be sent
to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForceCDER@fda.hhs.gov.

Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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