June 2005 - Pharmaceutical Technology

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June 2005

Pharmaceutical Technology
Volume 6, Issue 29

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


Combating counterfeit drugs strategy status report
The US Food and Drug Administration (Rockville, MD, http://www.fda.gov/) released its annual report on May 18 explaining the agency's campaign against 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 increased manufacturer vigilance.

The report does not say how many of those 58 initiated investigations have produced or are likely to produce arrests or product seizures. It does include an appendix that summarizes seven drug-counterfeiting cases that closed during the past year:

Counterfeit Lipitor

  • During the first quarter of 2005, three men pled guilty to federal criminal charges in a multimillion dollar Lipitor smuggling and counterfeiting conspiracy. To date, eight people have been indicted, four have pled guilty, and another was convicted by a trial 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 of conspiracy to introduce misbranded and unapproved new drugs into interstate commerce, counterfeiting human growth hormone, and possessing controlled drugs with the intent to distribute. Two other persons involved in these offenses were previously convicted and sentenced.

Counterfeit Viagra

  • In 2004, a counterfeiter pled guilty to conspiracy, trafficking in counterfeit goods, and a felony violation of the Federal Food, Drug and Cosmetic Act, admitting he conspired with a manufacturer in Beijing to import thousands of counterfeit Viagra tablets into the United States. He was fined $6000 and sentenced to 18 months in prison, 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 obtaining counterfeit Serostim (a formulation of somatropin human growth hormone) and selling it to bodybuilders. A collaborator pled guilty to similar charges in February 2003.

Counterfeit labeled pharmaceuticals
In October 2004, an Alabama drug wholesaling company was convicted, fined $24,000, and sentenced to five years probation.

World Express Rx
In January 2005, a San Diego man was sentenced to serve a 51-month prison term and to forfeit substantial cash proceeds for his role in operating a large Internet pharmacy scheme. The illicit drugs included products counterfeited in Mexico, India, and Pakistan, which were 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

Earlier in May, FDA took the unusual step of warning Americans against counterfeit Lipitor, Viagra, "and an unapproved product promoted as 'generic Evista'" sold in Mexican border-town pharmacies.

The "generic Evista" was made or distributed by Litio, whose label claimed that it was manufactured in Monterrey. FDA obtained it from a pharmacy in Agua Prieta (Sonora, Mexico), and conducted the analysis in conjunction with the National Association of Boards of Pharmacy.

The ersatz Lipitor and Viagra came from pharmacies in Juarez, Los Algodones, Nogales, and Tijuana. FDA reports that the counterfeit labels were in English, rather than the Spanish used on genuine Mexican drugs. Pfizer analyzed the samples of both drugs, FDA said.


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