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  • How a New Anonymous Network May Complicate FDA's Effort to Stop Counterfeit Drugs

    Counterfeit pharmaceutical products are among the most ominous challenges global regulators, including the US Food and Drug Administration (FDA), face on a day-to-day basis. FDA routinely goes after counterfeiters, working to dismantle their operations by seizing their web properties. For example, it has regularly worked with other regulators and law enforcement officials as part of Operation PANGEA, a massive operation which has taken down thousands of websites since ...
  • FDA Links up With EU Law Enforcement Agency Europol to Combat Fake Pharmaceuticals

    The US Food and Drug Administration (FDA) is stepping up its attempts to go after online pharmacies peddling counterfeit and fake medicines to US consumers, announcing that it is embedding one of its agents with EU's law enforcement agency, Europol. Background: Counterfeiting US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop pr...
  • ISO Releases New Voluntary Anti-Counterfeiting Standard

    The International Standards Organization (ISO), whose standards are commonly used by the life sciences industry, has released a new standard to allow for uniform authentication standards to combat counterfeit goods, including medicines and medical devices. The standard, ISO 12931: 2012 - Performance criteria for authentication solutions used to combat counterfeiting of material goods , discusses several "authentication solutions," including holograms, tags, and m...
  • Hamburg Continues to Call for More Anti-Counterfeiting Authority

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg remains adamant the agency needs more authority to go after counterfeiters . For the third time in as many months, Hamburg has spoken out publicly in an attempt to garner more attention for what she sees as a lack of legal and regulatory "teeth" to address the problem of fake and substandard drugs entering the US' pharmaceutical supply chain. Speaking on Wednesday, 7 June to The Financial Times , Ham...
  • MHRA Launching New Anti-Counterfeiting Strategy

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is unveiling a new Falsified Medical Products Strategy it says will improve its existing anti-counterfeiting strategy by enhancing communication, collaboration and regulatory activities between MHRA and stakeholders. The agency's updated strategy will seek to enhance its original strategy by focusing on preventing counterfeit products, changing how counterfeit products are handled once they are found...
  • With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy

    • 03 May 2012
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    The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain. EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the ...
  • Report: EU Anti-counterfeiting Directive Attracting Industry Praise, Scorn

    • 30 April 2012
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    A rash of counterfeit drugs invading the European pharmaceutical supply chain is spurring EU legislators to develop a new anti-counterfeiting directive that has attracted both the praise and scorn of regulated industry, reports Reuters . The European Commission's planned Directive involves requiring pharmaceutical products "to be sold in tamper-proof packs from 2016, each with a unique identifier allowing them to be tracked through the supply chain," writes Reuters . ...
  • EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy

    • 18 April 2012
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    The European Directorate for Quality in Medicines and Healthcare ( EDQM ), the Council of Europe's (EC) pharmaceutical standards body, announced it is continuing to develop and expand a new anti-counterfeiting strategy it says will reduce pharmaceutical-related crime. In its 18 April announcement, EDQM said the multi-layer legislative strategy aims to increase, among other things, training for inspection officials from EC member states, increased inspection and testing a...
  • Woodcock Calls for Prescription Drug Tracking System

    The US Food and Drug Administration (FDA) is calling for a prescription drug tracking system to ensure the pharmaceutical supply chain's integrity, reports The Financial Times . Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, testified before the House Energy and Commerce Committee on 8 March and called for Congress to grant FDA additional authority to secure the supply chain. "Currently there is no complete record of all parties who have b...
  • EMA to Focus on Pharmacovigilance, Counterfeiting

    • 22 February 2012
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    According to a report by PMLIVE Intelligence Online , the European Medicines Agency (EMA) is setting its sights on new pharmacovigilance laws and fighting counterfeit medicines.  The goals are outlined in the new EMA Work Programme 2012, which also outlines some cost-cutting measures for the current year. Despite these reductions, the EMA is expecting to increase its focus on the areas of pharmacovigilance and anti-counterfeiting. The report states these efforts ...
  • Spotlight on Counterfeiting After Fake Avastin Found in US

    Counterfeit copies of Avastin-an oncology drug with numerous indications-is casting a harsh spotlight on the safety of the pharmaceutical supply chain and causing experts to ask how it can be strengthened. Perhaps the most prominent idea put forth by experts is a so-called 'track and trace' system for verifying pharmaceutical integrity. The US Food and Drug Administration (FDA) is expected to release a proposal for such a system within the coming year, notes the Associ...
  • CBP Report Shows Dramatic Increase in Counterfeit Pharmaceutical Seizures

    • 11 January 2012
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    A new report released by the US Customs and Border Protection (CBP) on 9 January shows a dramatic increase in the amount of counterfeit pharmaceutical products seized by CBP during fiscal year (FY) 2011. Pharmaceutical products represented the third most popular category of commodities seized by CBP during FY 2011, representing 1,239 seizures worth $16.9 million, or 9% of all the value of all goods seized. This represents a three-fold increase over 2010, when CBP seize...