On October 24th, the Partnership for Safe Medicines gathered stakeholders in the efforts to combat counterfeit medicine in Washington D.C. for a one-day conference at the Newseum’s Knight Conference Center. This was our 4th annual conference, focused on U. S. drug supply chain security and the safety of American patients.
Speakers and panelists were drawn from all aspects of the fight to protect consumers from misbranded drugs. PSM Executive Director Scott LaGanga opened the Interchange by welcoming participants, “When a speaker talks about the major arrest of a counterfeit criminal, odds are good the special agent that brought him in is in the audience. The reporters that exposed their supply chain are here as well. When you hear about a counterfeited medication, odds are good that a patient advocate for that specific therapeutic group is here too.”
The day began with presentations of new research on counterfeit medication and drug diversion. Dr. Tim Mackey presented his paper; Clear and Present Danger: Availability of Dangerous, Unapproved and Recalled Drugs Online. Dr. Marvin Shepherd shared as yet-unpublished research on how Austin-area hospitals are targeted by questionable gray market drug sellers, some even on a daily basis.
Panel discussions throughout the day provided different perspectives on the counterfeit drug problem in the United States. Patient safety advocates answered the question “How Have American Patients Been Impacted by Counterfeit Medicines?” The panelists were led by Scott Williams of the American Cancer Society Cancer Action Network, who pointed out that “the burden of counterfeit medication is on cancer patients, because they may be easily exploited.”
Fake online pharmacies were the subject of the next panel discussion, moderated by Dr. Bryan Liang who spoke with representatives from the National Association of Boards of Pharmacy (NABP), the Food and Drug Administration Office of Criminal Investigations (FDA-OCI), and Community Pharmacies of Maine (CPM). Amelia Arnold, a clinical pharmacist from CPM, described the frustrations in getting accurate information to the public about the dangers of drug importation. CanaRX’s misleading marketing campaign “bowled over the employees union” and put law-abiding pharmacists like herself “on the right side of the issue, but the wrong side of public opinion” when it came to legalizing drug importation for Maine.
The United States Department of Justice (DOJ) was represented on the panel Bringing Criminals to Justice across Jurisdictions. Roger Gural from the DOJ Consumer Protection Branch described the arrest and conviction of Canadian fake online pharmacy entrepreneur Andrew Strempler. Mr. Gural pointed out that Strempler’s counterfeit drug scam was caught by pure luck, when a transit shipment of bulk counterfeit drugs that was passing through Miami en route from one South American country to another was intercepted by U. S. customs agents. The counterfeit Xanax discovered in Switzerland on the eve of the Interchange was actually caught in the same fashion by Swiss customs agents checking a transit shipment through their country.
Linda Marks, Senior Litigation Counsel for the Consumer Protection Branch of the DOJ, moderated the last panel discussion of the day, which focused on how the global counterfeit drug problem is affecting the United States. In discussing what she termed “a parade of horribles” from the annals of counterfeit drug crime, Ms. Marks showed the audience a graphic image of bulk fake Botox stored in a drug counterfeiter’s home refrigerator.
Dr. Ilisa Bernstein, Deputy Director of the Office of Compliance in the Center for Drug Evaluation and Research at the FDA, who provided the keynote speech for the day, pointed out that the threat of counterfeiting is present throughout the life cycle of any drug. Dr. Bernstein finished her speech by describing the three pillars of counterfeit drug enforcement: prevention, detection and response.
The day ended with a networking reception and a promise to save the date for the 2014 Interchange on September 18, 2014.