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To Import or Not To Import

That is the question that many of our lawmakers are asking. Senators Dorgan (D-ND), Snowe (R-ME), McCain (R-AZ) and Stabenow (D-MI) brought that question to the forefront when they introduced the “Pharmaceutical Market Access and Drug Safety Act of 2009” (S. 525) in March. Currently waiting to be placed on the Senate calendar, the bill would allow for prescription drug importation.

Bryan A. Liang, MD, PhD, JDLiang (sm)

That is the question that many of our lawmakers are asking.  Senators Dorgan (D-ND), Snowe (R-ME), McCain (R-AZ) and Stabenow (D-MI) brought that question to the forefront when they introduced the "Pharmaceutical Market Access and Drug Safety Act of 2009" (S. 525) in March.  Currently waiting to be placed on the Senate calendar, the bill would allow for prescription drug importation.

While a good-intentioned idea, the Partnership for Safe Medicines (PSM) believes that "Pharmaceutical Market Access and Drug Safety Act of 2009" will undermine nearly two decades of drug safety policy.  Throughout the past 16 years and under two administrations, no HHS Secretary—Democrat or Republican—has certified a drug importation plans—a clear indication of the extreme safety concerns associated with drug importation and the challenges with ensuring safety of the globalized drug supply.

Unfortunately, this legislation simply does not recognize the increasing vulnerability of the international supply chain. In fact, it would allow importation from several countries that have had recent problems with counterfeit drugs in their own country.  In the past three months alone, the Medicines Health products Regulatory Agency (MHRA)—the British equivalent of the U.S. Food and Drug Administration (FDA)—has issued two recalls for counterfeit insulin pens and inhalers.  The European Union's 2007 pharmaceutical counterfeiting data shows that almost 40 percent of fake medicines seized by the E.U. originated in Switzerland.  And according to the Pharmaceutical Security Institute (a member of the Partnership for Safe Medicines), last year, there were 104 reported incidents of counterfeit medicines in Japan, while Germany and Austria were in the top 10 countries where counterfeit drugs were most frequently seized or discovered.

Any time consumers are subject to drugs from outside of the U.S.'s currently closed drug supply chain, there is a very real risk to their health and welfare.  Foreign pharmacies are not subject to the FDA's jurisdiction and the exporting countries' equivalents of the FDA are not going to spend their limited resources scrutinizing drugs not earmarked for their citizens.  It is both impractical and not their legal responsibility. Additionally, criminals continually use European parallel importation and trade laws to slip counterfeit drugs into the legitimate supply chains of member countries that allow it, such as the United Kingdom.  Finally, there is no evidence that drug importation provides any real savings according to the Congressional Budget Office and independent academic analysis.

Policymakers should focus on lasting solutions built on access to safe, regulated drugs, and do not put the risk of policy failure on the most vulnerable groups—minorities, uninsured, seniors, and others on fixed incomes.  In the meantime, there are ways of reducing drug costs that are outlined at www.SafeMedicines.org that do not risk the patients' health.  These programs should be publicized and used to their fullest extent, particularly during these hard economic times.  But policies risking health of American citizens and their families should never be an option.  Because when it comes to the drug supply, safety is no accident.

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