50+: Live Better, Longer

The Letter (and Spirit) of Drug Import Laws

Don't Ask, Don't Tell continued...

Here's how the FDA puts it in a consumer advisory on its web site:

"Don't purchase from foreign web sites at this time because generally it will be illegal to import the drugs bought from these sites, the risks are greater, and there is very little the U.S. government can do if you get ripped off."

And there's the rub: the words "generally" and "at this time." Under current law, stated in an FDA "guidance" paper titled "Coverage of Personal Importations," the importation or interstate shipment of unapproved new drugs is prohibited. The definition of "unapproved" includes "foreign-made versions of U.S. approved drugs that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness. It is the importer's obligation to demonstrate to the FDA that any drugs offered for importation have been approved by FDA."

Under those rules, it appears to be illegal to import into the U.S. the cholesterol-lowering drug Lipitor purchased in Canada, even though the drug is made in Ireland for shipment to both the U.S. and Canada. To make things even more confusing, the FDA guidance cites "circumstances in which FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs."

These extenuating circumstances include importing an unapproved drug for a serious condition for which there may be no effective treatment available in the U.S. But the drug can't be marketed to U.S. citizens by distributors of the drug in question, the product can't be considered to "represent an unreasonable risk," and the patient doing the importing has to be ready to affirm in writing that the drug is for his/her own use. The patient also has to be willing to furnish contact details for a physician in the U.S., or provide "evidence that the product is for the continuation of a treatment begun in a foreign country."

To hedge its bets, the FDA cautions that "even if all of the factors noted in the guidance are present, the drugs remain illegal and the FDA may decide that such drugs should be refused entry or seized. The guidance represents the FDA's current thinking regarding the issues of personal importation and is intended only to provide operating guidance for FDA personnel. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind the FDA or the public."

As for the consequences, FDA associate commissioner for planning and policy William Hubbard told the Wall Street Journal in March 2003 that "any party participating in" an import plan in which a health insurer or claims processor helps arrange a purchase in Canada "does so at its own legal risk." The article also quotes Hubbard as saying that "our highest enforcement priority would not be actions against consumers."