Could the government be doing an about-face on drug importation? In case you missed it, in late February Health and Human Services (HHS) Secretary Tommy Thompson announced an HHS task force charged with determining whether drugs can be imported safely into the United States. Thompson said that the department has not previously been able to ensure the safety of imported drugs, but that the task force “will look to identify new solutions that could permit safe importation.” The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 apparently directed this action. It requires HHS to wrap up its study by December 2004.

FDA still remains skeptical, however. In an April letter to the New Hampshire Pharmacists Association, William K. Hubbard, associate Commissioner for Policy and Planning, wrote that “FDA has no way of assuring that [foreign] drugs will be the same.” There is doubt, he wrote, that they “even contain the same active ingredient.” Such products therefore “may be unsafe in a number of ways.” He then cited a number of manufacturing and control processes that help maintain the gold standard of drugs in the United States. Packaging and labeling controls, no doubt, are part of this system.

Will HHS, urged on by Congress, change FDA’s mind? It is too soon to tell. HHS seems to be devising other ways to make drugs more affordable. For instance, HHS just approved a Medicaid program in which five states will pool their collective purchasing power to negotiate discounts on prescription drugs for their state programs. The states include Michigan, Vermont, New Hampshire, Alaska, and Nevada. According to HHS, it is the first Medicaid program of its kind.

Lew Kontnik expects that HHS will make a serious inquiry into importation. Kontnik, a lawyer who has spent 20 years tracking counterfeiting developments throughout the world, testified at HHS’ last meeting on the topic. “Importation is a bad way to address the real issue, which is improving access to affordable drugs,” he says.

Such access is really a social and political issue for the United States, he says, and importing drugs from other countries will not work for the long term. For instance, U.S. demand for affordable drugs would exhaust Canadian supplies. “We’d clean their shelves in 23 days,” he says. Also, if importation becomes legal and companies begin setting up shop to import lower-priced drugs, what will stop these importers from buying low and selling high, he asks. “They won’t do it to benefit Grandma,” he warns.

Finally, importation may jeopardize the safety of the American public. “It is an issue of safety. The risk of buying counterfeit products will increase,” he says.

The debate over importation is a tough one, and I bet that pharmaceutical companies aren’t entirely for or against it. But I have to agree with Kontnik: “Importation acts as a surrogate for the real issue—drug pricing and access.”

A program like the Medicaid state pool is one solution, and there may be others that can help. But depleting another country’s supply—which is what the Canadian Pharmacists Association believes U.S. citizens are doing—is not the answer. Neither is opening our medicine cabinets to drugs produced by non-FDA-regulated entities. The risks are just too great.