April 10, 2008

Federal Efforts to Combat Fake Meds

Marv Shepherd, PhD

Counterfeit drugs, tainted medicines, rogue online pharmacies – inarguably a growing problem around the world. But what can our federal government do to help protect us here in the United States?

One of our government’s best weapons in the battle against counterfeit drugs is the Food and Drug Administration’s (FDA) Alert Network, a coalition of health professional and consumer groups. The Alert Network disseminates alert messages about counterfeit drug incidents in the U.S. and develops educational information about the roles and responsibilities consumers and professionals should play to identify and report counterfeit drugs.

And recently, it played a role in helping indict Georgios Xydeas, a Greek national, for selling counterfeit, misbranded and unapproved prescription drugs to online pharmacies and undercover agents.

In February 2007, the FDA issued an alert saying some Internet pharmacy customers were receiving a powerful anti-psychotic drug identified as Haloperidol, the active pharmaceutical ingredient found in Haldol, instead of the medication they ordered. The misbranded drugs were shipped from Greece and further investigation led agents to Xydeas.

Although the foreign-based aspect of this crime makes U.S. investigation and prosecution especially difficult (this single counterfeit drug case was investigated for three years by agents from the U.S. Department of Homeland Security’s Immigration and Customs Enforcement, the Food and Drug Administration’s Office of Criminal Investigations, DOJ’s U.S. Attorney’s Office and the Chinese government, with support from the U.S. State Department and Panamanian officials and assistance from the Eli Lilly Pharmaceutical Co., the Sanofi-Aventis Pharmaceutical Co., the British Medicines and Health Care Regulatory Agency), Xydeas is facing 43 criminal counts for his role as a suppler of these misbranded and counterfeit drugs from China.

As counterfeiters have grown more sophisticated and set-up deceptive online pharmacies to con patients, we can use some of that same technology to fight back against fake drugs. I’m proud the Partnership for Safe Medicines’ SafeMeds Email Alert System is part of the FDA’s Alert Network. Our email alert system sends official alerts from the FDA and other government agencies around the world to anyone—private citizens, public groups, corporations, associations. To learn more about the SafeMeds Email Alert System and sign up for this free service, please visit SafeMedicines.org.