Archive for January 2010

FDA Alert Regarding Counterfeit Alli

The U.S. FDA released an updated public health alert regarding counterfeit Alli being sold over the internet. According to the FDA, here’s what you need to know: Alli is an FDA-approved, over-the-counter weight loss drug. FDA lab tests have confirmed that counterfeit versions of the drug do not contain the FDA-approved active ingredient; rather, they…

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Jackson G, Arver S, Banks I, Stecher VJ. Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. Int J Clin Pract. 2010;64(4):497-504.

Counterfeit drugs are inherently dangerous and a growing problem; counterfeiters are becoming increasingly sophisticated. Growth of the counterfeit medication market is attributable in part to phosphodiesterase type 5 inhibitor (PDE5i) medications for erectile dysfunction (ED). Millions of counterfeit PDE5is are seized yearly and account for the bulk of all counterfeit pharmaceutical product seizures. It has…

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Kubic TT.* Law Enforcement and Industry: Key Partners for Safe Medicines. J Biolaw Bus. 2010;13(1&2):38-41.

Counterfeit and diverted medicines are a key public health concern. Developing as well as developed countries are experiencing increases in patient safety risks due to these illicit drug forms. Public-private coordination between industry stakeholders and law enforcement can address the developments and trends in the counterfeit and diverted drug arena. In this piece, one such…

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Liang BA.* International Drug Production and Supply: Challenges for Biopreparedness. J Biolaw Bus. 2010;12(3): 31- 34.

Biopreparedness uniquely relies upon drugs. However, the globalization of drug manufacturing and supply has created challenges to ensuring open and available access to these products. The heparin case illustrates the challenges of offshore and onshore efforts to secure the drugs necessary to address naturally-occuring and human-sourced biological agents. Economic incentives, international diplomacy, and alternative sourcing…

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Liang BA.* Supporting Pharmaceutical Diversion and Counterfeiting Prosecutions: A Role for Medical Professionals. J Biolaw Bus. 2010;13(1&2): 55-57.

Law enforcement efforts to prosecute pharmaceutical diversion and counterfeiting have begun to emerge as an important deterrent. By enlisting health care providers, the team of law and medical professionals can ensure that the full extent of harms is known to the court, and conviction results in appropriate penalties for this particularly atrocious crime.

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