Panel 1: Michael Levy, Food and Drug Administration
Michael Levy, acting director of the Office of Drug Security, Integrity and Recalls (ODSIR) in the Center for Drug Evaluation and Research's (CDER) Office of Compliance at the U.S. Food and Drug Administration, spoke on the reorganization of the CDER.
FDA's diversion and counterfeit criminal case information analyzed 5 years worth of cases to better understand criminal methods and prevent future incidents. Report provides a snapshop of illegal medicines trade in the US. While not broad spectrum, it only deals with OCI cases, it still provides an interesting picture of criminal drug schemes.
There are, broadly, three types.
1) Counterfeiting
2) Diversion Involving a Pharmacy and Pharmacist
3) Cargo Theft Diversion
Wholesalers and pharmacists are the greatest likelihood to be involved in medicine counterfeiting. The full report is available on their website. The presentation will be up later on the safemedicines.org website.
Additionally Levy address Operation Pangea IV. The International operation conducted with Interpol and the FDA shut down 13,500 illegal pharmacy websites, which says Levy is a "very, very small dent" in the world of fake online pharmacies. the FDA shut down 578 internet drug outlets. Interpol seized 45,500 packages. Approximately 2.4 million illicit and counterfeit pills were seized.
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