FDA Steps Up Action Against Counterfeit Drugs, Warns US Consumers Against Fake Medicine from Mexico

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:

Counterfeit Lipitor

• During the first quarter of 2005, three men pled guilty tofederal criminal charges in a multimillion dollar "Lipitor" smugglingand counterfeiting conspiracy. To date, eight people havebeen indicted four have pled guilty, and another was convicted by atrial jury.

• In September, a Belize citizen was convicted and sentenced to 10 months incarceration and one year probation.  

Counterfeit human growth hormone)

• In March 2004, a Texas man pled guilty to four counts ofconspiracy to introduce misbranded and unapproved new drugs intointerstate commerce, counterfeiting human growth hormone, andpossessing controlled drugs with intent to distribute. Two otherpersons involved in these offenses were previously convicted andsentenced.

Counterfeit Viagra

• In 2004, a counterfeiter pled guilty to charges of conspiracy,trafficking in counterfeit goods, and a felony violation of the FederalFood, Drug and Cosmetic Act, admitting he conspired with a manufacturerin Beijing to import thousands of counterfeit Viagra tablets into theUnited States. He was fined $6000 and sentenced 18 months inprison, followed by three years probation.
  

• In January 2005, a Southern California man pled guilty to importing counterfeit "Viagra" from China and manufacturing 700,000 counterfeit "Viagra" tablets at a laboratory in the United States. An accomplice was convicted of similar charges in September 2004. The total value of the counterfeit Viagra in this case is more than $5.65 million.

Counterfeit Serostim

• A June 2004 indictment charged an individual with obtainingcounterfeit "Serostim" (a formulation of somatropin human growth hormone)and selling it to bodybuilders. A collaborator pled guilty tosimilar charges in February 2003. 
  

Counterfeit Labeled Pharmaceuticals

• In October 2004, an Alabama drug wholesaling company wasconvicted, fined $24,000, and sentenced to five years probation.

World Express Rx

• In January 2005, a San Diego man was sentenced to serve a51-month prison term and to forfeit substantial cash proceeds for his rolein operating a large Internet pharmacy scheme. The illicit drugsincluded products counterfeited in Mexico, India, and Pakistan, whichwere then smuggled into the United States. At least 14 other individuals also are being prosecuted in California or Florida as part of this conspiracy.

Warning on Mexican Border-Town Counterfeits

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.

–Douglas McCormick