Burgess Opening Statement: O&I Hearing on Counterfeit Drugs
Posted by Jill Shatzen on February 27, 2014 | comments
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Washington, D.C. – Rep. Michael Burgess (R-TX), Vice-Chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, today delivered the following opening statement as prepared for delivery at a hearing titled “Counterfeit Drugs: Fighting Illegal Supply Chains”:

“The market for prescription drugs has been the catalyst for a continuing series of frauds against American manufacturers and has provided the cover for counterfeit drugs. The effect of these practices and conditions is to create an unacceptable risk that counterfeit, adulterated, misbranded, sub-potent or expired drugs will be sold to American consumers.

“Are these findings from today’s Committee memo?

“While they could be, they are, in fact, from the findings of the Prescription Drug Marketing Act (PDMA) of 1987.  That bipartisan law was the result of a series of hearings conducted under Chairman Emeritus Dingell by this very subcommittee. In the report accompanying the bill, this Committee found:

‘American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective.  This is not to say that the shelves of the Nation’s pharmacies are lined with substandard products, or that there are inadequate controls in the manufacturing process.  Rather, the integrity of the distribution system is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective or even counterfeit pharmaceuticals.’

“The U.S. has the best drug supply chain in the world, and while the Committee’s work in this area is long and notable, as medications have become more advanced, our supply chain faces equally consistent and sophisticated attacks each and every day by counterfeiters, rogue distributers and those willing to adulterate product.

“According to the World Health Organization, in 2010, worldwide counterfeit medicine sales topped $75 billion, a 90% rise in five years. Some speculate that number may continue to grow by 20% each year. Medicines purchased from illegal websites have been found to be counterfeit in over 50% of cases.

“International Policy Network, a British think tank, approximates that worldwide there are 700,000 deaths a year caused by fake malaria and tuberculosis drugs, with 100,000 deaths in Africa according to the World Health Organization. 

“At its most extreme, these criminals are willing to literally risk patients’ lives to sell counterfeits. As a physician, such immorality of knowingly sentencing a patient to death by denying them a treatment disturbs me to my core. 

“In my opinion, punishment for counterfeiting prescription medication is far from adequate. From fake flu vaccines to oncology drugs -- counterfeit medications have been able to enter the supply chain and even been administered.

“Detecting a counterfeit drug is very difficult, if not impossible. No field test can be performed to indicate whether a drug is fake or real, and even trained experts are often unable to detect whether a drug is what it purports to be. Counterfeit and other altered drugs present an unreasonable risk to Americans. 

“Thankfully, this Committee has remained vigilant and I believe the passage of the Drug Quality and Security Act last year will provide an invaluable tool – which was too long in the making – to further tighten our distribution system.

“While our system might be the best in the world, our healthcare workforce does not have the confidence they should that the drugs they are dispensing or administering are the ones that came from the manufacturer. 

“I will also note that a December 2005 report found that nearly half of the imported drugs the FDA intercepted from four selected countries to fill orders placed with firms consumers thought were Canadian, in fact, 85 percent actually came from 27 other countries around the globe. A number of these products also were found to be counterfeit.

“Maintaining the integrity of the United States’ prescription drug supply is a compelling national priority that requires national solutions involving business, healthcare providers, and government coming together and being vigilant in the face of these threats. 

“The vigilance of this Committee continues today.”


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