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As an integral part of the ongoing effort to secure America’s boarders from illegal, counterfeit and substandard pharmaceuticals, the FDA has taken a more proactive approach. Their goal is to prevent these types of products from ever entering the legitimate US drug supply chain. To this end, the FDA has analyzed data from existing drug related cases involving counterfeit and diversion activities. This is a first step toward helping the agency prioritize their risk management and implementing effective strategies to defuse this threat. After using cases investigated by the FDA we have this statement taken from the preliminary report of the analysis, “review revealed various schemes and examples of the types of players in the supply chain, how different products enter the supply chain, and how fraudulent or diverted products were discovered. Having a better understanding of these characteristics will help [FDA] to identify potential vulnerabilities.” As an example, the report describes a counterfeit drug scheme in which the products were stopped at the border; a diversion scheme illustrating vulnerabilities to the supply chain when unscrupulous wholesale distributors are involved; and a diversion scheme involving a pharmacy and a pharmacist who sold diverted drug samples. The FDA plans to continue conducting in-depth analyses and issuing reports as appropriate. The more these schemes are exposed in detail, the easier it will become to identify and neutralize these activities - as well as punish the offenders involved. The FDA web site has made the latest report available to the public, “Preliminary Review of Agency’s Diversion and Counterfeit Criminal Case Information”. The FDA notes that the report is based on an initial review of “case information and does not contain statistical inferences, future trend predictions or opinions. With this preliminary review under its belt, we can expect the FDA to be an instrument of change in minimizing the vulnerabilities we face related to illegal, counterfeit and substandard pharmaceuticals entering our drug supply chain. Obviously, this is an ongoing process as new drugs continue to enter the market, and as existing drugs gain in popularity or are reclassified. The threat will remain; however, the ways in which we protect ourselves against such threat will continue to evolve. Remember that there is always something we can do to protect ourselves and our households. Companies such as Legit Script, which is the only Internet pharmacy verification and monitoring service endorsed by the National Association of Boards of Pharmacy (NABP), are on hand to provide guidance and safety to consumers. Author's Biography: John Horton is President and Founder of LegitScript, and a former aide in the White House Office of National Drug Control Policy (ONDCP). After five years working for the “Drug Czar,” John Horton founded LegitScript with the intent of helping people be sure that they are buying safe and genuine prescription medication on the Internet. LegitScript, is an internet enforcement service group, that has been successfully investigating sites to determine whether or not such sites are in compliance with the law and accepted standards of medical and pharmacy practice ethics.
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