Drug Serialization Trends and Developments


The sale and use of counterfeit medicines pose a real and potent threat to global health and commerce. Over the past decade, the threat of counterfeit medicines has increased, with incidents of counterfeiting reported in 123 nations. One watchdog group documented 2,193 incidents of pharmaceutical crime in 2013 alone, representing almost a 9 percent increase from 2012. This rise can be attributed largely to the growing online pharmaceutical marketplace that enables counterfeit drugs to permeate households. Counterfeit pharmaceuticals often lack active ingredients, depriving the patient of the medication they need. Even worse, counterfeit drugs have been found to contain poisons such as arsenic, shoe polish, nickel, and leaded road paint. While many counterfeits reach patients through online markets, these falsified medications have also penetrated legal supply chains.
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Global Pharmaceutical Product Serialization: Taking Steps Against Counterfeiting


The global market for counterfeit medicines has been rapidly growing during the last few decades, with estimates of its current size between $75 billion and $200 billion.  Authorities around the world seize large quantities of fake medicines annually, yet this does not deter counterfeiters who have only increased in terms of sophistication and numbers.
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FDA and Potential New Rules for Labeling of Generic Drugs


For the nearly 30 years since the Hatch-Waxman Amendments created the Abbreviated New Drug Application (ANDA) pathway to expedite generic drug approval, the Food and Drug Administration (FDA) has created rules to ensure that the labeling for a generic drug is the same as the labeling for the reference listed drug, commonly referred to as “the duty of sameness.”  As part of this rulemaking, the FDA has held that the Changes Being Effected (CBE) rules that allow sponsors of approved New Drug Application (NDA) drugs to unilaterally change labels to strengthen warnings are not available to ANDA holders.  The FDA, however, has announced that it will soon publish a Notice of Proposed Rulemaking entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” [Read more…]