Imported prescriptions: A prudent FDA crackdown

Internet pharmacies and storefront operations that offer offshore prescription drugs to American patients can expect to find themselves in trouble with the FDA.

Editorial. April 28, 2003.

When an offer seems too good to be true, it very well might be. The Food and Drug Administration is wisely taking this dictum to heart in stepping up enforcement of laws against the importation and sale of medicines from abroad.

And this effort is leading the agency to look especially hard at operations close to home -- businesses that sell Canadian prescription drugs to U.S. consumers via the Internet and storefront operations.

Here's why. About 10% of Canada's drug market is diverted to the United States. The reason: Price controls there make Canadian-approved drugs more affordable than those approved and marketed here.

That raises some basic problems. These prescription medications are not technically FDA-approved. They offer none of the official public health assurances of quality, purity, efficacy and safety that come with the FDA's imprimatur -- the world's gold standard. And their means of distribution are outside the realm of proper pharmacy licensing. Thus, the FDA considers them a growing public health risk.

In March, the FDA joined forces with pharmacy boards in Arkansas and Oklahoma, issuing a warning to Rx Depot Inc., which processes Canadian prescriptions through storefront operations in Arkansas, Oklahoma and three other states. The FDA told Rx Depot that it considers the company's operations to be "a clear violation of the drug safety laws that protect Americans from unsafe drugs."