Leahy-Grassley Bill To Increase Penalties For Counterfeit Drugs Adopted In FDA Bill

WASHINGTON (Wednesday, May 23, 2012) – Legislation authored by U.S. Senators Patrick Leahy (D-Vt.) and Chuck Grassley (R-Iowa) to increase penalties for trafficking counterfeit drugs was adopted by the Senate Wednesday as part of a substitute amendment to the Food and Drug Administration user fee legislation being debated this week.  The legislation responds to recommendations made by the U.S. Intellectual Property Enforcement Coordinator and the administration’s Counterfeit Pharmaceutical Inter-agency Working Group.

“Few things are more important to consumer well-being than ensuring the safety of our pharmaceutical supply chain,” said Leahy.  “Law enforcement is finding counterfeit versions of drugs that patients rely on to treat blood clots, cholesterol, prostate cancer, influenza, Alzheimer’s, and other serious conditions.  Counterfeit drugs reportedly result in 100,000 deaths globally each year, and account for an estimated $75 billion in annual revenue for criminal enterprises.  We must do more to prevent and deter this conduct.”

“Those trafficking counterfeit pharmaceuticals put lives at risk, and the penalties should reflect the threat and danger of these drugs,” Grassley said.  “Illegal counterfeit drugs are a multi-billion dollar global industry that's growing at an alarming pace, especially online, so there's no time to waste in creating an effective deterrent and making certain that justice is served with meaningful penalties.  Our bipartisan legislation is designed to meet this important goal, and the broader-based drug safety bill is an ideal way to move it forward.”

The Counterfeit Drug Penalty Enhancement Act will increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public.  While it is currently illegal to traffic in counterfeit drugs, the penalties are no different than those for the trafficking of other counterfeit products, such as clothing.  The Counterfeit Drug Penalty Enhancement Act will target violators that endanger consumer safety by trafficking in counterfeit medicines.

The Counterfeit Drug Penalty Enhancement Act is supported by the pharmaceutical industry and consumer groups like the Alliance for Safe Online Pharmacies and Easter Seals, and the U.S. Chamber of Commerce. 

The legislation was unanimously approved by the Senate in March.  It awaits action in the House of Representatives.

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