The Letter (and Spirit) of Drug Import Laws (cont.)
While the practice of reimporting drugs from Canada, Mexico, or other countries is still technically illegal (with the possible exceptions noted below), it is increasingly becoming a custom more honored in the breach than in the observance. The U.S. House of Representatives has passed three versions of bills that would allow consumers to import legal drugs for personal use. A similar measure, known as the Dorgan-Snowe Drug Importation bill, is currently before the Senate.
In the meantime, the mission of the FDA, as always, is to promote and protect the health of Americans. The mission of the U.S. Customs service is to enforce Federal laws and regulations as they pertain to imported substances such as drugs. And here's where the law gets kind of squishy.
Current law says that if Granny decides she can get her heart medications more cheaply in Alberta than in Alabama, she could be busted for either bringing it over the border or having it delivered to her. Does that mean that dear Granny is likely to do a stretch in solitary? Hardly, experts say, because nobody wants to be seen putting the cuffs on elderly pensioners. Also, they'd have to arrest the governments of the states of Wisconsin, Minnesota, Illinois, Vermont, as well as many city governments and private employers who have turned north for lower-cost prescription drugs.
Next: Guidance From the FDA
Don't Ask, Don't Tell
When it comes to the importation of drugs from foreign countries, the FDA acts a bit like Captain Renault in Casablanca who tells Rick that "I am shocked, shocked to find that gambling is going on in here!" as he gambles in Rick's club.
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."