Policy and Law

Acri née Lybecker, Kristina M.L., State Pharmaceutical Importation Programs: An Analysis of the Cost Effectiveness (June 12, 2019). Colorado College Working Paper 2019-02 June 2019.

Abstract Recently proposed legislation in Colorado, Connecticut, Florida, Maine, Missouri, Oklahoma, Oregon, Utah, Vermont and West Virginia aims to reduce spending on pharmaceuticals by importing them from Canada. To examine the cost effectiveness of importation, this study analyzes 24 drugs from an online Canadian supplier, accounting for the cost savings, the cost of testing, the…

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Former FBI Director Louis Freeh Updates His 2017 Report on the Threat of Congressional Drug Importation Proposals

Former FBI Director Louis Freeh has released an addendum to his 2017 Report on the Potential Impact of Drug Importation Proposals on U.S. Law Enforcement, concluding:

…the government has not done enough to evaluate and improve the capacity of law enforcement to deal with a new pipeline of drugs into the U.S. drug supply, all while . . . more illegal drugs are being shipped to the United States. Passing any drug importation scheme would erase the little progress we have made and set law enforcement further back on their heels.

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Guerra C, Mackey TK. “USA criminal and civil prosecutions associated with illicit online pharmacies: legal analysis and global implications.” Med Access @ Point Care 2017; 1(1): e104-e118.

  ABSTRACT The rise of digital technologies has created a complex online environment that now includes illicit Internet pharmacies, online facilitators, advertising sites, and foreign entities. Collectively, these networks create significant patient safety risks, including acting as unregulated access points encouraging prescription drug use. Although law enforcement is active in combatting this form of cybercrime,…

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Traynor, Kate. “California pharmacy board takes next steps toward electronic pedigree.” American Journal Of Health-System Pharmacy 70, no. 4 (February 15, 2013): 303-304.

The article reports that the California State Board of Pharmacy held a meeting in December 2012 to address comments from the public regarding requirements for electronic record of transactions for prescription drugs.   Traynor, Kate. "California pharmacy board takes next steps toward electronic pedigree." American Journal Of Health-System Pharmacy 70, no. 4 (February 15, 2013):…

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Dégardin, Klara, Yves Roggo, and Pierre Margot. “Understanding and fighting the medicine counterfeit market.” Journal Of Pharmaceutical & Biomedical Analysis 87, (January 18, 2014): 167-175.

Abstract Medicine counterfeiting is a serious worldwide issue, involving networks of manufacture and distribution that are an integral part of industrialized organized crime. Despite the potentially devastating health repercussions involved, legal sanctions are often inappropriate or simply not applied. The difficulty in agreeing on a definition of counterfeiting, the huge profits made by the counterfeiters…

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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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Liang BA,* Mackey TK. Stem Cells, Dot-Com. Sci Transl Med. 2012 Sept 12; 4;151:151-9.

Abstract. Direct-to-consumer (DTC) advertising of suspect goods and services has burgeoned because of the Internet. Despite very limited approval for use, DTC stem cell–marketed “treatments” have emerged for an array of conditions, creating global public health and safety risks. However, it remains unclear whether such use of stem cells is subject to drugs or biologics…

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Mackey TK, Liang BA*. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. J Pharm Sci. 2011 Nov;100(11):4571-9.

Abstract Counterfeit drugs are a global problem with significant and well-documented consequences for global health and patient safety, including drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of counterfeits is also wide in breadth and scope, including…

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Liang BA.*, Mackey TK. Promoting online drug safety: Using Public–Private Partnerships to Deter Illicit Online Drug Sales. J Commer Biotechnol. (2011) 17, 266–271

Illicit online pharmacies selling counterfeit drugs in a global virtual marketplace remain a critical problem in global health. Yet they continue to operate with little regulation while growing numbers of consumers access the Internet for health information that may lead them to purchase dangerous drugs online. This global social problem requires immediate action to protect…

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