Global Supply/Parallel Trade

Bastiaan J Venhuis, Angela E Oostlander, Domenico Di Giorgio, Ruth Mosimann, Ines du Plessis. Oncology Drugs In The Crosshairs Of Pharmaceutical Crime. The Lancet. 2013;19:e209-15.

Oncology drugs clearly have become a target for pharmaceutical crime. In 2016, falsified oncology drugs ranked fifth in the most commonly falsified drug category among the reports received by the Pharmaceutical Security Institute. Although the prevalence of illicit oncology drugs in the legal supply chains appears to be small, these drugs are difficult to detect,…

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Nayyar, Gaurvika M. L. et al., “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives,” The American Journal of Tropical Medicine and Hygiene, Volume 92, Issue 6_Suppl, Jun 2015, p. 2 – 7

Introduction This supplement to the American Journal of Tropical Medicine and Hygiene, entitled “The pandemic of falsified medicines: laboratory and field innovations and policy perspectives,” showcases 17 articles on detection technologies and methods, field surveillance data, multisectorial perspectives, and policy interventions and recommendations needed to create a coordinated and effective response to curb the pandemic…

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Mackey, Tim K.*, and Bryan A. Liang*. “Pharmaceutical digital marketing and governance: illicit actors and challenges to global patient safety and public health.” Globalization & Health 9, no. 1 (November 2013): 1-21.

BackgroundDigital forms of direct-to-consumer pharmaceutical marketing (eDTCA) have globalized in an era of free and open information exchange. Yet, the unregulated expansion of eDTCA has resulted in unaddressed global public health threats. Specifically, illicit online pharmacies are engaged in the sale of purportedly safe, legitimate product that may in fact be counterfeit or substandard. These…

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Glass, Beverley D. “Counterfeit drugs and medical devices in developing countries.” Research & Reports In Tropical Medicine 5, (March 2014): 11-22.

Abstract:  The World Health Organization has reported that counterfeit medicines potentially make up more than 50% of the global drug market, with a significant proportion of these fake products being encountered in developing countries. This occurrence is attributed to a lack of effective regulation and a weak enforcement capacity existing in these countries, with an…

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Hottinger M, Liang BA*. Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs. Am J Law Med. 2012. Forthcoming. Available at SSRN: http://ssrn.com/abstract=2121528.

Abstract: Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman law. Yet with current drive toward lowering costs focusing upon generic formulation of drugs, potential safety issues have arisen. Although there is an established criterion of…

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Campbell N, Clark JP, Stecher VJ, Goldstein I. Internet-ordered viagra (sildenafil citrate) is rarely genuine. J Sex Med. 2012 Nov;9(11):2943-51. Epub 2012 Aug 27.

Abstract Introduction.  Counterfeit medication is a growing problem. This study assessed the requirement for prescription, cost, origin, and content of medications sold via the Internet and purporting to be the phosphodiesterase type 5 inhibitor Viagra (sildenafil citrate). Methods.  Pfizer monitored top search results for the query "buy Viagra" on the two leading Internet search engines…

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McCoy D, Pitsillidis A, Jordan G, et al. PharmaLeaks: understanding the business of online pharmaceutical affiliate programs. In: Security’12 Proceedings of the 21st USENIX conference on Security symposium. Pages 1-1; USENIX Assn Berkeley, CA 2012.

Abstract: Online sales of counterfeit or unauthorized products drive a robust underground advertising industry that includes email spam, "black hat" search engine optimization, forum abuse and so on. Virtually everyone has encountered enticements to purchase drugs, prescription-free, from an online "Canadian Pharmacy." However, even though such sites are clearly economically motivated, the shape of the underlying…

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