Commercial importation of prescription drugs by large wholesalers could be
rendered safe under certain stringent criteria, according to a report by the
U.S. Department of Health and Human Services (HHS).
But the cost of ensuring safety of imported drugs would be in the hundreds
of millions of dollars, while legalized drug importation from price-controlled
countries would do little to solve the problem of high drug prices in the U.S.
Moreover, legalized importation by wholesalers would likely reduce incentives
for research and development of new drugs here in the United States, HHS
Meanwhile, the government's report, intended to provide guidance to
Congress in considering legislation to legalize drug importation, paints a
negative picture of private importation by individuals, saying it would be all
but impossible to ensure safety of such imported drugs.
In a press conference on the day the report was released, U.S. Surgeon
General Richard Carmona, M.D., said the estimated cost of ensuring safety of
privately imported drugs would be about $3 billion.
There are also potentially profound safety issues related to private
importation of drugs, the scope of which cannot be gauged since the role of
imported drugs in adverse events is likely to be hidden.
"If you have a senior citizen with a heart condition who buys some
Internet medications then a week or two later dies of heart failure, it may
never be known [if the patient died as a result of the drug]," Carmona
But the HHS report did at least suggest that ensuring safety of drugs
imported wholesale by large commercial suppliers is feasible—though it
would be difficult, costly, and of questionable benefit in the long run
(see box below). The
report also states that the only country from whom safety of imported drugs
could be ensured is Canada.
"If Congress is willing to consider importation from Canada, it must
be specifically regulated much like the FDA regulates sale of pharmaceuticals
in the U.S.," Carmona told reporters. "We would have to make sure
that the manufacture, storage, and shipment of imported drugs conforms to U.S.
guidelines and that there is a pedigree so you can know the lifetime of that
medication, where it started and where it ended, to make sure that it hasn't
Carmona added that importation would only be advisable for drugs that are
in high demand and are especially costly in the United States.
Key findings in the 144-page report include the following:
During Congressional debate on drug importation proposals, APA expressed
concern to Congress about the absolute need to ensure the safety of
medications brought into the United States under any legislative proposal or
by administrative action.
"Certainly, we would agree with the AMA that the overarching concern
must be to maintain absolute assurance of patient safety as Congress and the
administration work to make prescription medications more affordable,"
said Nicholas Meyers, director of APA's Department of Government
The American Medical Association likewise hailed the emphasis on public
health safety. "While we are still reviewing [the report], we are
pleased with the report's focus on ensuring access to drugs that are safe and
effective, as well as affordable," said AMA Trustee Edward Langston,
M.D. "We will carefully review the recommendations of today's HHS
[report] and continue to work to ensure that our nation's prescription drug
supply is as safe and as affordable as possible."
At the interim meeting of the AMA House of Delegates last month in Atlanta,
delegates voted to support importation of prescription drugs by wholesalers
under conditions that are similar to those spelled out in the HHS report
(Psychiatric News, January 7). They include the following:
At the same meeting, the AMA also reiterated its opposition to personal
importation of prescription drugs via the Internet until patient safety can be
The HHS report on prescription drug importation is posted online at<www.hhs.gov/importtaskforce/Report1220.pdf>.▪