Legislation

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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Former Director of the U.S. FDA’s Office of Criminal Investigations Warns Against Allowing Drug Importation

More than 60,000 Americans died from drug overdoses last year. Fentanyl, a synthetic opioid 100 times more powerful than morphine, caused one-fifth of those fatalities. Local law enforcement and health professionals are working at a feverish pace to prevent fatal overdoses, yet at the same time, some federal lawmakers have proposed legislation that would make it legal to import drugs that are not approved by the Food and Drug Administration into the United States from questionable sources. Such legislation would provide a gateway for international criminal organizations to import counterfeit prescription drugs and deadly illegal opioids, including fentanyl…

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Former Attorneys General of Georgia and Florida Speak Out Against Drug Importation

The bills before Congress would remove many of the license and oversight requirements on the drugs imported into the United States by lifting those barriers, inviting an influx of bogus pharmaceutical products from the same crime rings that are selling these drugs in other countries around the world that would love better access to the U.S. market.

Law enforcement would inevitably be tasked with policing the problem, at a time when most prosecutors and law enforcement officials have their hands full with the growing opioid crisis. One of the biggest killers is fentanyl, a potent, synthetic opioid pain medication that is being laced into counterfeit pills.

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Former FBI Director Discusses the Dangers of Allowing Drug Importation in Radio Interview

Freeh warned that allowing drug importation from Canada was akin to allowing drugs to be imported from anywhere. Quality would be at risk, and the opioid crisis, an epidemic that killed over 33,000 Americans in 2015, would only get worse. He said that allowing drug importation, “…will not only fuel that, but it will also, in my opinion, encourage a lot of criminal groups and organizations that heretofore have not been involved in this trade, but will see huge opportunities to enter the market.”

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Investigation by Former FBI Director Louis Freeh Finds Congressional Drug Importation Proposals Would Pose Significant Threats

Law Enforcement Would Carry Costs and Burdens Related to Opening U.S. Drug Supply to Increased Threat of Foreign-Sourced Counterfeits “Permitting prescription drug importation would lead to an increased flow of counterfeit and other potentially dangerous products across U.S. borders, worsen the opioid crisis, and cause unnecessary strain on law enforcement and already-overburdened government regulators, according…

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The American Pharmacists Association Writes Congress to Oppose Importation

On March 22, the American Pharmacists Association (APhA), which represents 64,000 pharmacists, pharmacy technicians, pharmacy students and other pharmacy professionals wrote a letter to Congress opposing plans to legalize importation of non-FDA approved drugs. These proposals, they wrote, are “in direct conflict with recent efforts by Congress and federal agencies to increase the integrity and security of the U.S. drug supply.”

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