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The US Food and Drug Administration today released its annual reporton the Agency's campaignagainst counterfeit prescription drugs.
The report says FDA's Office of Criminal Investigations (OCI) launched 58 inquiries in 2004 (up from 30 in 2003) "involving hundreds of thousands of fake dosage units."
The report credited the increase to stepped up enforcement action,increased collaboration with state and private agencies, and increasedmanufacturer vigilance.
The report does not say how many of those 58 initiatedinvestigations have produced or are likely to produce arrests orproduct seizures. It does include an appendix that summarizes sevendrug-counterfeiting cases that closed during the past year:
Last week, FDA took the unusual step of warningAmericans against counterfeit Lipitor, Viagra, "and an unapprovedproduct promoted as 'generic Evista'" sold in Mexican border-townpharmacies.
The "generic Evista" was made or distributed by Litio, whose labelclaimed that it was manufactured in Moneterrey. FDA obtained it from apharmacy in Agua Prieta (Sonora, Mexico), and conducted the analysis inconjunction with the National Association of Boards of Pharmacy.
The ersatz Lipitor and Viagra came from pharmacies in Juarez, LosAlgodones, Nogales, and Tijuana. FDA reports that the counterfeitlabels were in English, rather than the Spanish used on genuine Mexicandrugs. Pfizer analyzed the samples of both drugs, FDA said.
The Agency statement noted that US and Mexican officials arecooperating in an effort to curtail trade in counterfeit drugs andthat Mexico's Federal Commission for the Protection from Sanitary Riskshas recently shut down 19 pharmacies and confiscated 105 tons of fakemedicines.