Current law prohibits importing drugs that have not been approved by the FDA, including foreign versions of drugs that are approved for use in the U.S., and reimportation of approved drugs made in the U.S. Still, more and more patients searching for affordable medications are resorting to such a practice.

Testifying before a Senate committee last month, a senior FDA official reported that up to two million packages containing FDA-regulated products are mailed to individuals for their personal use in the U.S. each year. Seizure of parcels by the U.S. Customs Service containing controlled substances at international mail facilities increased by 450% in Fiscal Year 1999, primarily due to drug sales over the Internet.

FDA reminds us that it cannot establish where such drugs were manufactured or under what conditions; there is no way of knowing if they were packaged and stored under the conditions needed to avoid contamination or degradation. It is not uncommon to find drugs that have been withdrawn from use in the U.S. because of safety hazards, including drugs that have been associated with heart attack, stroke, and dangerous drug interactions. Drugs that have failed to win approval because they are not effective are also intercepted in the mail.

Next week, we'll look at some exceptions to the law barring importing of drugs.

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