PSM’s President Weighs in on Importation Fueling Fentanyl Epidemic

As PSM’s Board President, Dr. Marv Shepherd, wrote in an editorial for the Washington Examiner that was published on October 10, 2017, opening the United States to unregulated, imported drugs will offer fentanyl traffickers even more access to Americans:

“The reality is that criminals throughout the illegal supply chain from China to the streets of U.S. cities are making money at the cost of American lives. We need to be taking steps to eliminate illegal fentanyl from our communities, not providing new avenues for those who want to see just the opposite happen.”

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Texas Policy Analyst Questions Economic Impact and Safety of Drug Importation

Russell Withers, general counsel at the Texas Conservative Coalition Research Institute in Austin, believes that drug importation is “neither affordable nor safe.” In a September 20, 2017 editorial in the Austin-American Statesman , he argues that “it would hurt U.S. and Texas businesses, workers and patients’ and urges Texan congress members to oppose it.

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US Will Be Exposed to Counterfeits From Weak European Drug Security Warns Expert

In early July, European authorities reported that counterfeit versions of Omnitrope, a drug containing human growth hormone, were found in France, Denmark, and Mexico. The counterfeit Omnitrope was designed to look like it was made by a large drug manufacturer, but it contained no active ingredient. Shortly thereafter, German authorities announced that a fake version of a schizophrenia drug, Xeplion, was discovered in Germany. The Xeplion was also a knock-off, mimicking packaging used in Bulgaria and Romania.

These incidents are the latest in a stream of reports about counterfeit drugs throughout Europe. The problem lies in lax security of the supply chain — distributors, middlemen and wholesalers between the drug maker and the consumer. Despite ongoing problems with the EU drug supply chain, Congress is currently considering a bill that would open the U.S. to imports from the EU and elsewhere. We can’t have a serious debate about drug importation without understanding what is going on in Europe.

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Health Policy Expert: “Why Cheaper Drugs Can Kill”

Health policy expert Kenneth Thorpe weighs in on the dangers of drug importation in this August 23, 2017 editorial in U.S. News & World Report:

“…these savings could come at the cost of Americans’ lives. Legalizing drug importation would make it far easier for harmful counterfeit and contaminated medicines to enter the U.S. drug supply. At a time when illegal, counterfeit drugs already cause hundreds of American deaths every year, importation represents a reckless way to cut health care costs.”

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Bioworld: Importation a cliché, not a CAPA

Mari Serebrov, the regulatory editor for biotechnology news site BioWorld, offered this opinion about drug importation on August 4, 2017.  

“On the surface, importing drugs from Canada seems like a no-brainer,” she writes, “especially when the Canadian version is virtually the same drug as the one approved by the FDA for the U.S. market – except a whole lot cheaper. But there’s the rub. How can Congress ensure that drugs imported from Canada are all that they claim to be?

While more than 40 countries have or are implementing security measures to protect their drug supply chain, Canada’s not one of them, Brian Daleiden, vice president of industry marketing at Tracelink Inc., told BioWorld. That puts importation – from Canada, at least – on a collision course with the U.S. Drug Supply Chain Security Act (DSCSA), which Congress passed in 2013 as part of the Drug Quality and Security Act.”

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Physician: Sanders’ drug proposal comes with serious costs

The Daily Herald published this editorial by Dr. Terry Sellers about the shortcomings of drug importation as policy on July 25th, 2017. Sellers is a Utah-based physician specializing in addiction.

“… price is not the same as cost,” he writes, “In this case, cheaper prices will impose tremendous costs that would adversely affect the future of medicine for generations to come.” 

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