Drug Importation
In 2017, the four most recent U.S. Food
and Drug Administration (FDA) commis-
sioners sent a letter to Congress asserting
that drug importation would “harm patients
and consumers and compromise the care-
fully constructed system that guards the
safety of our nation’s medical products.” 13
The U.S. drug supply is among the
safest in the world according to the FDA,
and federal protections create a closed drug
distribution system to assure U.S. consum-
ers of that safety. “Public health is at
risk when the safety measures put in
place by federal laws and regulations
are undermined or absent through the
importation of unapproved foreign
drugs,” Lyndsay Meyer, of the FDA’s
Office of Media Affairs, told ASH
Clinical News.
Chain of Command
Part of the FDA’s role in overseeing the
U.S. drug supply chain is regulating
the importation of drugs from other
countries to ensure those drugs are
from legitimate sources and are manu-
factured, transported, and stored under
appropriate conditions.
The agency claims that 40 percent
of the finished pharmaceuticals sold
in the U.S. are imported and that 80
percent of active pharmaceutical ingre-
dients found in U.S. drugs are foreign-
made, but according to research by
PharmacyChecker.com, 70 percent of
the top 40 brand-name drugs sold in
the U.S. were foreign-made. 14
“The FDA says buying medication
online is not safe, yet we already rely to
some degree on foreign regulators to
protect our drug supply,” Mr. Levitt said
in a press release about the research.
The FDA has regulatory authority
over these foreign-made ingredients or
products; without this federal over-
sight, it would be difficult to guarantee
that drugs imported from other coun-
tries are from a legitimate, regulated
supply chain in that country, Ms.
Meyer said.
In addition, the FDA said that if
a Canadian company is selling drugs
only for export to the U.S., and not to
Canadian citizens, Health Canada (the
country’s health department) might
not regulate the drugs or the company
at all. Drugs coming to the U.S. from
Canada may be coming from some
other country and simply passing
through Canada.
However, Mr. Levitt argued that,
although this is a popular talking point
for PhRMA and the FDA, it is not
entirely accurate.
“If you call the pharmacy boards
in Manitoba or British Columbia, they
will tell you that, if a prescription is
mailed from a licensed pharmacy in
Canada to a patient in the U.S., it must
be a Health Canada–approved drug.”
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ASH Clinical News
Counterfeit Goods
Mr. Levitt considered many concerns
about counterfeit drugs to be exaggerated.
“Personal drug importation, when done
wisely, is … a lifeline of more affordable
medications for Americans who need them,”
he said.
Dr. Adler recently discussed drug
importation with a patient with chronic
myeloid leukemia who has been on Gleevec®
(imatinib) for 10 years. About four to five
years ago, the price of Gleevec was $11,000
for a 90-day supply. The patient, who was
also a physician, decided to research drug
importation online. He purchased Gleevec
through the online pharmacy CanadaDrugs.
com for $1,600 for a 90-day supply. The pa-
tient’s wife, a breast cancer survivor, receives
her hormone therapy medications through
the same website.
However, Dr. Alvarnas has person-
ally witnessed the dangers of obtaining
drugs from outside the FDA’s safety chain.
When he practiced in Arizona, one of Dr.
Alvarnas’ patients crossed the border into
Mexico to purchase lower-cost pharma-
ceuticals. She wanted access to medicine
she couldn’t afford, but the medication she
bought turned out to be counterfeit and
caused her death.
The U.S. has pursued litigation against
potential bad actors. In 2015, the U.S. De-
partment of Justice announced indictments