Research: Policy and Law

Investigation by Former FBI Director Louis Freeh Finds Congressional Drug Importation Proposals Would Pose Significant Threats

Law Enforcement Would Carry Costs and Burdens Related to Opening U.S. Drug Supply to Increased Threat of Foreign-Sourced Counterfeits “Permitting prescription drug importation would lead to an increased flow of counterfeit and other potentially dangerous products across U.S. borders, worsen the opioid crisis, and cause unnecessary strain on law enforcement and already-overburdened government regulators, according…

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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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Danzon P, Johnson SJ, Long G, Furukawa MF. Commercial Importation of Prescription Drugs in the United States: Short-Run Implications. Journal of Health Politics, Policy and Law 2011 36(2):295-316.

The option of legalizing the commercial importation of prescription drugs is of continued policy interest as a way to reduce U.S. drug spending. Using IMS data, we estimate potential savings from commercial drug importation under assumptions about percentage of drugs likely to attract imports; potential supply from foreign countries; and share of savings passed on…

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Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825.

Direct-to-consumer advertising (DTCA) is legal only in the United States and New Zealand and has been linked with drug overutilization, public health concerns, and higher costs. 1 Despite global proscriptions, DTCA is the most rapidly increasing form of pharmaceutical marketing, with approximately $4 billion in US expenditures, outpacing physician marketing and research and development. Liang…

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