European authorities are warning that vials of Roche's cancer med Herceptin that were stolen in Italy are now showing up across the continent with little or none of its active ingredient.
Track-and-trace is on its way. Eli Lilly, with its 10-year history of fighting counterfeits, is in a good position to make the switch, and now it's putting the wheels in motion to get the project underway.
One tactic of U.S. authorities in fighting the onslaught of illegally imported and sometimes counterfeit drugs is to prosecute doctors who bought them knowing they came from outside the legitimate supply chain. A Missouri doctor whose practice, The Youthful Body, bought a foreign version of Allergan's Botox to get a deal is now going to jail for just that.
Labels on shipments to a St. Louis, MO, suburb, arranged by two men from Turkey said they contained "gifts" and "documents." Instead, federal prosecutors and the FDA said the shipments were illegal, and sometimes counterfeit, cancer drugs being smuggled in from outside the U.S.
Part of the new Drug Quality and Security Act, approved in the U.S. last fall, sets in motion a timeline to eventually have serialization on individual drug units and a system to track them from manufacturing to pharmacy.
The FDA's Office of Criminal Investigations is establishing a closer relationship with the Europol law enforcement agency to attack the problem of counterfeit drugs sold online at its source.
Chinese authorities warned 6 months ago that they were on the lookout for drug counterfeiters who often sell their fakes worldwide over the Internet. This weekend they made good on that threat, rounding up 1,300 people and confiscating $362 million worth of drugs and raw materials.
The FDA and other federal authorities have brought down an Arlington, VA-based company that bought unapproved, foreign versions of Botox and cancer drugs on the black market, often receiving the sterile drugs in a condition that left their quality and sterility in question.
The Drug Quality and Security Act, approved by the Senate Monday and now awaiting the president's signature, lays out limited FDA powers to oversee the compounding pharmacy industry and kicks off the process of establishing a so-called national track-and-trace system
A longtime goal of the FDA is for the industry to put in place a national system that would allow it to follow a drug product from manufacturer to pharmacy. After years of back-and-forth with the industry about how that would be done, it is about to get started.