Two Men Charged for Illegally Importing Counterfeit Medications

The U.S. Department of Justice (DOJ) announced the arrest of two people for illegally importing counterfeit weight loss products including GlaxoSmithKline’s alli.

According to the DOJ, the two Chinese born men, imported weight loss products they claimed were cheaper versions of FDA approved medications.

Sengyang Zhou, a Chinese national was arrested in Hawaii last week. Zhou, during the course of the investigation implicated himself as the maker of the counterfeit Alli.

Qin Ming Hu, a U.S. citizen, born in China was arrested in Plano; Texas last week. According to the DOJ the charges could result in nearly 20 years of prison time and hundreds of thousands in fines for Zhou and several years in prison and fines of nearly $250,000 for Hu.

"The Food and Drug Administration will work together with other government entities to aggressively target those individuals who put the public's health at risk by selling counterfeit drugs," FDA Commissioner Margaret Hamburg said recently in a published statement.

The two men were apparently successful in marketing their bogus products over the Internet to consumers seeking less expensive medications online. The counterfeit medications, identical to the packaging of the branded medications, reportedly contained dangerous levels of the active ingredient used in the authentic drugs.

XStream Systems encourages all members of the pharmaceutical supply chain to use an authentication process to verify their inventories and protect healthcare consumers from dangerous adulterated, fraudulent, sub potent and counterfeit medications.

To learn more about an anti-counterfeiting technology which is being used to discover fraudulent, adulterated and counterfeit drugs in the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

FDA News: GSK Works With eBay to Stop Online Counterfeit Alli Sales

The following news release was posted online at FDANews.com:

GlaxoSmithKline (GSK) is working with eBay to remove online auctions of counterfeit Alli and inform consumers about potentially counterfeit product sold on similar websites.

eBay is removing auctions of the weight-loss drug Alli (orlistat) covered by the alert and asking sellers to review FDA communications to make sure they have legitimate Alli before relisting it for sale, Jack Christin Jr., eBay associate general counsel for government relations, said.

Pictures of counterfeit Alli samples of the packaging and product provided by GSK can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm

To learn more about technologies that can verify drugs in their unit of sale container without degradation or destruction, visit: http://www.xstreamsystems.net/.

To read the entire FDANews news release, visit: http://www.fdanews.com/newsletter/article?articleId=124314&issueId=13409.

FDA News Release: Counterfeit Alli

As reported earlier in Secure Pharma Chain Blog, the FDA Warns Consumers via a press release about Counterfeit Alli.

The counterfeit products contain controlled substance sibutramine. The following is the press release from the FDA.

The U.S. Food and Drug Administration is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores.

The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

• Outer cardboard packaging missing a “Lot” code;
  
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);


• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;


• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;


• Contains larger capsules with a white powder, instead of small white pellets.
  

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Pictures of counterfeit Alli samples of the packaging and product provided by GSK can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm

To learn more about technologies that can verify drugs in their unit of sale container without degradation or destruction, visit: http://www.xstreamsystems.net/.

FDA: Counterfeit Version of Alli May Harm Consumers

Three separate media outlets are reporting the Food and Drug Administration’s announcement about a counterfeit version of the GlaxoSmithKline OTC drug Alli.

The following are web links to stories from CNNMoney.com, the Wall Street Journal and MedPage Today.

CNNMoney.com reported, "A counterfeit version of the over-the-counter weight-loss product Alli being marketed online could be harmful to dieters, the US Food and Drug Administration warned." The agency "said the counterfeit Alli was sold in 60 mg capsules as part of a 120 count refill kit." Alli manufacturer GlaxoSmithKline "said tests showed the falsely packaged and labeled products contained a controlled substance called sibutramine."

The Wall Street Journal reports that sibutramine is the active ingredient in Abbott Laboratories' prescription weight-loss treatment Meridia. The FDA said that "sibutramine...should not be used in certain patient populations or without physician oversight." Glaxo noted that while patients should take Alli three times a day, Meridia should only be taken once daily.

The agency said the fake products are missing a "'Lot' code on its cardboard packaging," MedPage Today reported. In addition, the counterfeit has "an expiration date that includes month, day, and year...instead of month and year," and contains "plain foil inner seals as opposed to the genuine articles printed, 'SEALED for YOUR PROTECTION.'"

To learn more about technologies used to detect counterfeit medications, visit: http://www.xstreamsystems.net/.