OP-ED: why drug importation is flawed policy

With the issue of prescription drug importation being debated on Capitol Hill again, mark me in the skeptical camp. As a matter of safety and practical policymaking, drug importation simply doesn’t work.

It is not by happenstance that our country has the world’s safest drug supply. Counterfeit medicines are proliferating around the world and the people who do this are brilliant at making these products look just like the real deal. According to Interpol, approximately 30 percent of all medicines in Africa, Latin America and Asia are thought to be counterfeit. While our relatively closed distribution system prevents these medicines from infiltrating our drug supply, those that make it in can cause significant damage to patients. From opioids that treat chronic pain to chemotherapies that treat cancer, there are too many instances of patients being directly harmed by illegally imported drugs.

Unfortunately, we don’t take counterfeiting practices as seriously as we should. A friend of mine recently purchased a new name-brand golf driver on the internet at less than one-third its retail price. It turns out that his “good deal” was a knock-off, skillfully made to look like the real thing but without the quality provided by the patent-holding manufacturer. Similar situations happen with all kinds of consumer goods; however, it is substantially more serious when it involves powerful chemicals that are ingested into one’s body. They are not one and the same.

The U.S. Food and Drug Administration regulates the manufacture and distribution of medicines in the U.S. throughout, and extensively along, the distribution chain. Importing drugs that are not subject to rigorous FDA standards and allowing them into the U.S. drug supply would be tantamount to eliminating current consumer protections. Even the real medicines would have no FDA testing for safety, and written materials, such as consumer information and warnings, might not be accurate. Undermining the security of our system with foreign drugs that may not have the same chemical or biologic makeup, may require special handling (in regard to temperature, light, etc.), and have not had their clinical data, labeling, or manufacturing operations reviewed by the FDA would constitute a mistake.

I’m one of many HHS Secretaries who found it impossible, based on the preponderance of evidence and data before me, to certify that importation of medicines from unregulated sellers is safe. In fact, my predecessors and successors from both political parties, along with multiple FDA Commissioners, have consistently found that drug importation carries potential dangers that can’t be ignored.

The FDA does not inspect or approve drugs that are intended to be sold in Canada. While our regulatory bodies can know whether a bottle of blood pressure medicine or diabetes drug originated in Canada or some other country, they need to be put in charge in order to do so. The “Canadian” medicines that Americans might purchase could come from China, Mexico, or other countries with extraordinarily high counterfeiting rates. Not surprisingly, Canadian officials are on record saying that they are not responsible for the safety and quality of prescription drugs imported into the United States.

The health and safety of our population is too serious a cost to pay in a misguided effort to achieve undocumented savings. When something seems as easy as looking outside the U.S. border for a solution, Congress should take a step back and assess why the people who have seen the consequences firsthand are steadfastly opposed to it.

Former Utah Gov. Mike Leavitt served as Secretary of Health and Human Services from 2005 to 2009. Safemedicines.org