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Recent developments in the U.S. concerning dangerous counterfeit drugs

Thanks to our friend James L. Bikoff of Silverberg, Goldman & Bikoff, LLP who reports on several developments in the U.S. concerning dangerous counterfeit drugs, all of which reemphasize curbing counterfeit drugs in the United States

Thanks to our friend James L. Bikoff of Silverberg, Goldman & Bikoff, LLP who reports on several developments in the U.S. concerning dangerous counterfeit drugs, all of which reemphasize curbing counterfeit drugs in the United States:

First, the U.S. Food and Drug Administration (FDA) recently announced that it “will increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division…” The FDA – which investigates drug counterfeiting and improper marketing of narcotic drugs – has authority to hold corporate executives strictly liable for criminal actions within their companies. Though the FDA has not used this ability in recent years, in moving forward it “intends to apply the provision thoughtfully and doesn’t want to be viewed as overly aggressive.” Ultimately, the agency has declined to name specific kinds of corporate wrongdoing it wants to pursue under this provision.

A second, rather disheartening article, highlighted the “massive trade in faked pharmaceuticals” that the FDA is tasked with investigating. “The February 2010 issue of The International Journal of Clinical Practice reported that the sale of counterfeit drugs almost doubled in the past five years and is expected to reach $75 billion in 2010.” The article explained that FDA seems woefully ill equipped to investigate and combat this growing problem. “Even with new resources, the FDA will inspect only a small percentage of U.S. imports, especially compared to its mandate to regulate products that amount to 20% to 25% of the U.S. economy.” Many import entry lines into the U.S. are not attended by FDA staff. Delay of imports due to stepped up investigation efforts inevitably results in complaints from citizens. And “potential purchasers of counterfeit drugs number in the tens of millions.” “No longer are the buyers mainly recreational drug users buying narcotics, but average citizens trying to obtain low-cost drugs for legitimate medical problems.”

Third is an update to our report on a January 10, 2010 FDA warning on counterfeit and “potentially harmful” versions of GlaxoSmithKline’s ALLI – an FDA approved over the counter weight loss drug. The U.S. Justice Department recently charged two individuals with illegally importing counterfeit ALLI from China containing ingredients that can lead to heart attacks. The two individuals – a Chinese national and a U.S. citizen born in China – used websites, email and the U.S. Postal Service to peddle the knockoff drugs, which were advertised as cheaper versions of the federally approved ALLI. If convicted, each could face several years in prison – up to 20 years – and hundreds of thousands of dollars in fines.

These reports certainly indicate that sale and importation of counterfeit drugs are a growing problem internationally.

James L. Bikoff Silverberg, Goldman & Bikoff, LLP jbikoff@sgbdc.com