Inside Washington: Reimport Battle Complicates Anticounterfeiting Campaign

FDA and manufacturers seek to curb bogus drugs, while legislators consider liberalizing import policies to cut pharmaceutical costs.

Export officials estimate that 20 million packages containing pharmaceuticals come into the United States each year — and 14% have something wrong with them. The rise in Internet pharmacies is spurring the import trend, as are higher prices of drugs and biotech therapies in the United States.

This surge in imported prescription therapies is raising concern at FDA and among manufacturers that the door is opening to a flood of counterfeit and unapproved drugs and biologics. Ironically, members of Congress could make it easier for counterfeit drugs to enter the United States by pressing for legislation that would enable individuals and pharmacists to reimport lower-cost drugs from abroad. Advocates aim to increase consumer access to less expensive medicines, despite protests from FDA and industry that the policy is unwise and unworkable. Meanwhile, manufacturers are examining how new technologies can prevent product tampering and identify counterfeits, while backing policies to protect product names and patient safety.

Attack on Counterfeits

As counterfeit cases piled up in recent months, FDA launched a more aggressive program to halt the influx of bogus drugs from abroad (see

www.fda.gov/oc/initiatives/counterfeit

). The agency established an internal task force in July to explore the use of new technologies and identify enforcement actions that could stymie distribution of counterfeit medical products. The panel — led by John Taylor, associate commissioner for regulatory affairs, and Bill Hubbard, associate commissioner for policy and planning — is scheduled to report recommendations this month.

The initiative stems from evidence of rising counterfeit pharmaceutical distribution in the U.S. FDA opened 22 counterfeit drug cases in 2002 and 20 cases in 2001 — big jumps from about 5 to 6 cases each year previously. Since 1996, FDA counterfeiting investigation cases have led to 44 arrests and 27 convictions. Most cases involved high-cost injectables and high-volume drugs, such as statins, AIDS therapies, and antidepressants. One report speculates that unscrupulous distributors are diverting to the United States some low-cost and free drugs intended for foreign medical aid programs.

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