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Patients, Pharmacists, Physicians Speak Out Against Risk of Counterfeit Drug Importation

Testimony Before HHS Task Force to Stress Dangers of Imported Medicine

Tuesday April 13, 2004
Source: The Partnership for Safe Medicines

On the eve of a Department of Health and Human Services Task Force Public Hearing, the Partnership for Safe Medicines, a nonprofit coalition of more than 40 healthcare and anti- counterfeiting groups, called widespread prescription drug importation an unacceptably dangerous and inherently unsafe practice that should remain illegal.

The Department of Health and Human Services Task Force on Drug Importation has scheduled a series of public hearings to receive testimony on drug importation proposals. The April 14 hearing is expected to draw a large number of opponents of the practice, including pharmacists, physicians, patients and community activists.

"Doctors need to know that when they prescribe a drug for a patient, that they will be able to get real medicine that really does what it should," said Dr. Rene Rodriguez, president of the Interamerican College of Physicians and Surgeons. "If these misguided proposals become law, no doctor will be able to have that confidence and the health and safety of millions of Americans will be compromised."

Among the individuals to testify are AIDS patient Rick Roberts, a victim of counterfeit Serostim, a medicine that works to combat wasting syndrome.

"I had been through a lot while dealing with my illness, but this was one of the toughest," Roberts said. "There was finally a drug available that could help me and instead of getting that drug, I was injecting myself with something completely different -- I'm lucky to be alive."

In its February 2004 report, Combating Counterfeit Drugs, the FDA said it "has recently seen an increase in counterfeiting activities as well as increased sophistication in the methods used to introduce finished dosage form counterfeits into the otherwise legitimate U.S. drug distribution system ... Thus, drug counterfeiting poses real public health and safety concerns today, and may pose an even greater threat in the future if we fail to take preventative measures now ... Although exact prevalence rates in the U.S. are not known, outside the U.S. drug counterfeiting is known to be widespread and affect both developing and developed countries. In some countries more than half of the drug supply may consist of counterfeit drugs."

"There can be little doubt that terrorist groups are capable of exploiting the counterfeit trade to accomplish their goals," said Lew Kontnik, a counterfeiting expert and author of the book Counterfeiting Exposed. "We remain exposed to counterfeiters and criminals -- maintaining and strengthening a safe, closed prescription drug system is the best defense."

According to Industry Canada, the Canadian government trade agency, there were significant increases in Canadian imports of pharmaceuticals from Singapore (30%), Ecuador (198%), China (43%), Iran (2,753%), Argentina (221%), South Africa (84%) and Thailand (52%) between September 2002 and September 2003. Counterfeiting rates in South Africa and Thailand are reported to be 30% or higher, and Iran has been identified by the U.S. Department of State as an active state sponsor of terrorism. None of these countries have a Mutual Recognition Agreement on Good Manufacturing Practices with Canada, which means that prescription drugs from these countries are not eligible for sale to Canadian citizens.

"The FDA has determined that it cannot certify the safety of the millions of medicines that pass through Canada. For that matter, Canadian healthcare representatives won't do it either," said spokesman for the Larry King Cardiac Foundation and Multiple Sclerosis patient Mark Barondess. "I believe that one of the greatest threats we are currently facing in this country is the prospect of importation of drugs through Canada. Quite frankly, I am shocked that the government is even considering such a proposal."

The Partnership for Safe Medicines is a diverse network of organizations concerned about consumer safety threats posed by the purchase and use of unapproved, counterfeit, substandard, mishandled or otherwise unsafe medicines. The Partnership is also concerned about the risks to consumers that would be caused by allowing commercial importation of medicines from unknown, unverified or unsafe foreign sources. For more information and consumer tips on safe medicines, please visit

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