Track-and-Trace Not Enough to Halt Drug Counterfeiters

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks from drug counterfeiting activities, noted Marcia Crosse, director

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for healthcare at the Government Accountability Office, testifying at a Feb. 27, 2014 hearing before the House Energy and Commerce, Oversight and Investigations subcommittee.

A main problem is that penalties for distributing counterfeit drugs are too low to spur prosecution and to deter illegal operators, explained Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy. FDA is working with other federal agencies to identify and take action against illegal operators, with a focus on fraudulent Internet pharmacy sites that sell low-cost “Canadian” medicines. But most counterfeiters end up facing charges of “misbranding” or importing “unapproved foreign-made drugs,” which carry minor fines and minimal jail terms.

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Health Reform May Boost Illicit Drug Sales

Health plans that limit drug converge may encourage consumers to obtain medicines illegally, according to pharmacy experts. Marv Shepherd, director of the Center for Pharmacoeconomic Studies at the University of Texas College of Pharmacy and others noted at the Partnership for Safe Medicines Interchange in October in Washington that an increase in narrow health plan formularies that carry only one or two drugs per class or category will boost purchases of substandard, counterfeit and diverted prescription medicines through illicit operators. Patients accustomed to treatment with a certain drug may seek out other sources of supply if a streamlined plan fails to provide coverage for that medicine, explained Bryan Liang, anesthesiologist and law professor at the University of California San Diego.

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Quality Manufacturing Key to Global Attack on Fake Drugs

Jill Wechsler Washington EditorThe growing dangers from substandard and falsified medicines around the world has prompted a blue-ribbon panel formed by the Institute of Medicine (IOM) to call for clear international standards for higher quality medical products,  plus an electronic tracking system in the US to uncover bogus products in the supply chain. Read more »

Sanofi Campaign Targets Counterfeit Medicines

Stephanie Sutton Pharm Tech EuropePassengers travelling via Air France this December will see an in-cabin movie made by Sanofi to raise awareness about the dangers of counterfeit drugs.

According to Sanofi’s video, up to 10% of the world’s medicines can be counterfeit. In industrialised countries, counterfeit medicines are rare and many patients and consumers may not be fully aware of the dangers. In other locations, however, such as some countries in Africa, Asia, Latin America and in emerging markets, counterfeit medicines may comprise 20–30% of the market. Travellers are not always aware of the risk when venturing to another country. Read more »

Color-Changing Sealant Technology Enhances Package Security

Rollprint Packaging Products’ new, patent-pending, color-changing sealant technology is appropriately named Chameleon; it enhances product security with a color change indicating that a pouch or tray lid has been opened. Read more »

Anticounterfeiting Success in the UK

Stephanie Sutton Pharm Tech EuropeIn the last five years, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized counterfeit drugs worth more than £25 million ($41 million), but the war isn’t over yet. Counterfeit products are still a threat to the UK, which is why the agency has launched a new anticounterfeiting strategy called the Falsified Medical Products Strategy 2012–2015. The strategy includes several measures centred around prevention, incident management and investigation. Read more »

EFPIA Moves Forward With Verification system

Stephanie Sutton Pharm Tech EuropeFor some time, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been working on developing a European verification system to help combat falsified medicines. The system, the European Medicines Verification System (EMVS), now seems close to implementation as EFPIA has launched a tendering process to select potential vendors for the technology. Read more »

Counterfeit Woes in the West

Stephanie Sutton Pharm Tech EuropeLast week, counterfeits of the anti-cancer drug Avastin were discovered in the US and this week fake pharmaceuticals continue to occupy headlines. Read more »

NPOs Lead the Way at CPhI

Rich WhitworthAnother very busy day at CPhI Worldwide and co-located events with good meetings in every corner for all exhibitors.

If you missed yesterday’s blog, the winner of the Innovation Awards was Glycotope for its GlycoExpress platform technology, which optimised glycosylation of antibodies and other biotherapeutics. The award was received by a very proud and happy Jens Pohl, managing director on Oct. 25, 2011. Read more »

Pharma Scammers A Tweet

Stephanie Sutton Pharm Tech EuropeThe pharma industry has been scratching its head for some time about how best to exploit social media and efforts in this area have been tentative with uncertainty over regulations. Pharmaceutical spammers, on the other hand, have little reason to hold back. Already, spammers are taking advantage of Twitter to promote cheap pharmaceutical products such as Viagra and Levitra. Indeed, a recent study by the University of Akron in the US explained that Twitter “presents a new forum for spammers to facilitate illegal pharmaceutical scams”. Read more »

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