I was honored to present at the 7th Annual Pharma Anti-Counterfeiting and Brand Protection Summit in Philadelphia on the issue of illicit trade of unsafe medicine, representing Partnership for Safe Medicines.
The United States is considered to have the safest drug supply in the world. However, as many as 19 million Americans purchase pharmaceuticals outside of this legitimate supply chain, from online pharmacies and unlicensed sources.
How this happens
Since 2012, smugglers caught selling fake drugs sold up to 63 medications to over 3000 doctors, clinics, and hospitals across the United States. These counterfeit medicines lack authentication and the safety of FDA regulations. Some of these drugs contain lethal ingredients, such a Fentanyl, while others do not contain active ingredients at all. Either case can lead to death. [See detailed patient cases in slide deck here].
Equipment to create counterfeit drugs is readily available. Pill presses and medicine die molds can easily be purchased on the internet. Fentanyl and alprazolam can be illegally imported from China.
There are other legislative threats and enforcement dangers associated with this illicit industry. Imported drugs, whether they are sold by wholesalers or retailers, are not monitored by any regulatory agency. U.S. Regulators cannot ensure the safety of pharmaceuticals produced outside FDA-approved sources.
Even with regulatory agencies, law enforcement, and USPS working together, the amount of inbound international mail is almost impossible to inspect. And all of these organizations put themselves at considerable risk investigating these cases, for 2mg of Fentanyl can be lethal dose.