Authorities in Brazil have seized counterfeit versions of two Schering-Plough drugs that are popular among bodybuilders.The country's National Health Surveillance Agency (ANVISA) says enforcement officers seized and destroyed three lots of counterfeit Schering-Plough products. According to SecuringPharma, the counterfeits were two lots of Schering-Plough's Deca-Durabolin and one lot of hormone-based therapy Durateston, which is made by its subsidiary Organon. SecuringPharma says Schering-Plough confirmed that it had not manufactured the products and that the lot numbers on the packaging didn't match numbers it uses on its own products. It also noted that one lot of Deca-Durabolin drugs seized was labeled as being 250 mg, which is not a formulation Schering-Plough makes.Durateston is a testosterone product and Deca-Durabolin is used to treat postmenopausal women with osteoporosis. Both promote muscle growth and are frequently sought out by bodybuilders. The seizures of counterfeits have been on the rise around the world. The European Union recently reported an enormous increase in counterfeit drugs, many of them coming out of China. China recently announced that it had rounded up nearly 2,000 drug counterfeiting suspects and destroyed 1,100 production plants. The U.S., meanwhile, has arrested and prosecuted a number of counterfeiters.
- read the SecuringPharma story
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Wednesday, 5 September 2012
National Health Surveillance Agency-Counterfeit Versions-Counterfeit Drugs-Schering-Plough
Thursday, 21 June 2012
Federal Authorities-Prescription Drugs-Internet Pharmacy-Canadian Internet-Counterfeit Drugs
The founder of a Canadian Internet pharmacy accused of selling counterfeit drugs will be arraigned this week in federal court, putting other operators around the world on notice that the U.S. is stepping up enforcement on that loose link in the supply chain in which thousands of Internet sites sell drugs of unknown origin to people without prescriptions.The 38-year-old Andrew Strempler, who was arrested last week, was a pioneer in this arena. In an indictment he and his former company RxNorth.com are accused of selling and shipping to U.S. consumers fake and misbranded drugs between early 2005 and the summer of 2006, The Wall Street Journal reports. Strempler sold his company to a competitor in 2006, and was believed to have hightailed it to the Caribbean after U.S. authorities accused him of selling counterfeit medications. Authorities globally have been trying to figure out how to attack the growing problem of counterfeit drugs making their way to consumers through this unregulated end-run around the legitimate supply chain.The arrest follows an FDA warning in May that fake versions of the ADHD drug Adderall, made by Teva Pharmaceutical Industries ($TEVA) and other generics companies, is showing up on Internet pharmacy sites. At least some of the counterfeit Avastin discovered in the U.S. in February squeezed its way in through a Canadian pharmacy company that delivers discounted prescription drugs from overseas to U.S. citizens.The owner of one Canadian Internet pharmacy acknowledged shipping at least some of the fake injectables of the Roche ($RHHBY) drug into the U.S. but said he notified authorities when he learned they were counterfeit.In a report in March 2011, the Counterfeit Pharmaceutical Inter-Agency Working Group, made up of a host of federal agencies and authorities, acknowledged the growing threat and said it was looking for ways to be proactive to a threat that is global in nature and difficult to monitor. In a recent interview, Connie Jung with the FDA explained that illegal Internet pharmacies presented a particular challenge to federal authorities because they may sell counterfeit or other unapproved drugs. Jung is the acting associate director for policy and communications within the Office of Drug Security, Integrity and Recalls. It was established last year to focus on such problems as drug counterfeiting in an industry that now relies on a global supply chain. Part of its work is to coordinate with other agencies like Customs and the FBI to find ways to be proactive in the face of a serious threat."Consumers and healthcare providers can be confident that consumers are receiving safe, effective, high quality drugs from their local pharmacies," Jung says. "It is when we have entities that choose to buy outside the legitimate drug supply chain that harmful products may be introduced." The U.S. is not alone in trying to figure out how to get on top of this new outlet for counterfeits. China Daily reports that after a 5-month investigation into counterfeiting there, the State Food and Drug Administration sent 670 cases to the police for investigation. "Many counterfeit drug cases featured online advertisements and sales, underground production workshops and transfers through postal express," Yin Li of the SFDA says.- read The Wall Street Journal story
- get the China Daily storyRelated Articles:
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Sunday, 29 April 2012
Counterfeit Drugs-Fda Commissioner-Track And Trace-Cancer Drug
Drug manufacturers may have derailed the FDA's plan to force creation of a vial-specific tracking plan to combat counterfeit drugs.The plan is facing resistance from companies like Pfizer ($PFE) and Merck ($MRK), as well as from pharmacies and distributors. It is estimated it would cost pharmacies $6 billion to put their piece in place.The industry is backing a plan that tracks lots instead of individual containers. They say it could be refined later to track smaller quantities. The plan put up by an industry coalition would put unique serial numbers on individual drug packages, but require scanning drugs only in "lots" when they get to distributors."Often in crafting policy, there's the search for the perfect and we just walk by the good," Pfizer spokesman Peter O'Toole told Reuters. "We could be saying in 10 years, 'we have to work on something perfect.' And in the intervening years, we would have done nothing, and that would be a shame for patients."The discovery of fake versions of Roche's ($RHHBY) cancer drug Avastin throughout the U.S. in recent weeks has added to the urgency to create a program."To learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable," FDA Commissioner Margaret Hamburg recently wrote on the agency's blog. "We ... need authority to require a robust system to track and trace all drugs throughout the supply chain."The discussion of how to trace individual containers has been going on for a long time, but no one wants to foot the bills. The experience of California is an indication of how difficult it has been to get the industry's support. It passed a track and trace law in 2004, but opponents have repeatedly delayed implementation. It is now set to go online in 2015.The FDA and the industry are both seeking to have the outlines of a plan included in FDA user fee legislation now before Congress, but which plan, if any, makes it in is still up in the air.- here's the Reuters storyRelated Articles:
FDA warns 56 more docs of fake Avastin supplies
Fake Avastin case highlights need for supply-chain controls read more..