May 21, 2003 WASHINGTON (AP) -- The Food and Drug Administration said Tuesday it is notifying buyers from a shipment of what was supposed to have been Viagra that agency mishandling allowed the unapproved generic product to be released mistakenly.
The FDA is sending a letter to each consumer who received the impotence remedy, apparently made in the Central American country Belize, alerting them that, because it was an unapproved generic, the agency could not vouch for its quality, safety or effectiveness. Pfizer Inc. owns a patent on Viagra, which means no generic version can be approved.
Through a series of procedural irregularities, the FDA said, it released the imported product to people who had ordered it even after the determination that it was not Viagra.
The number of imports has jumped in the past 20 years. Over 8 million products -- regulated and unregulated -- were presented for import last year.
The Port of Miami mail facility in Florida, where the generic Viagra shipment arrived, alone receives more than 100,000 packages a day. The large increase in imports has meant an increased need for surveillance. The FDA has doubled its import operations, but officials say its staffing and finances are too little to handle the increasing workload.
The FDA monitors imports and inspects and analyzes thousands of imported products.
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