Drug Importation
The Dangers of Drug Importation
Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious risk to public health.
The U.S. Food and Drug Administration (FDA) is the gold standard when it comes to reviewing and approving drugs. Medicines that enter the United States through importation schemes would not be subject to these same strong standards and, as a result, counterfeit, substandard or diverted, repackaged and adulterated drugs could be introduced into our secure drug supply chain. Importation schemes could have life-threatening consequences.
overview
1 in 10
medicines
of internet drug outlets
9 million
fraudulent medical devices and illicit pharmaceuticals
Why Drug Importation is Bad for Patients
Importation schemes have been proposed at various times as an approach to reducing drug costs. However, these proposals fail to acknowledge the resources required to run importation schemes and the inability to guarantee savings for patients. They also ignore that generics comprise more than 90% of the U.S. market today and are widely available lower-cost alternatives for patients. Not to mention, the exponentially higher risk of counterfeit, adulterated and substandard products entering the United States and harming patients would be playing roulette with patients’ lives.
why bad
Two Decades of Drug Importation
In 2003, the Medicare Modernization Act gave the Secretary of Health and Human Services limited power to allow the importation of some drugs from Canada, but only if the Secretary could certify the imports would both 1) pose no additional risk to public health and safety, and 2) generate cost-savings for American consumers. To date, not a single Secretary, from Democratic and Republican administrations, has been able to make these certifications. Even in 2020, despite claims to the contrary, the Secretary was no more able to certify than his predecessors and questionably circumvented the statute by punting the responsibility to state governments.
Over the years, a handful of states have piloted drug importation programs as a way to provide access to drugs from outside the United States, but there has yet to be a successful program. For example, six states tried a contracted importation program with a Canadian operator of online pharmacies that cost $1 million to implement. Four years later, the program was deemed a failure and terminated.
history
Related Resources
Why drug importation is bad for Americans
Drug importation schemes are dangerous and have significant negative consequences for both individuals and our health care system. Importation refers to when governments or individuals circumvent the U.S. Food and Drug Administration’s (FDA) regulatory review and approval process to acquire unapproved prescription drugs from other countries outside of our secure drug distribution system. Without proper FDA oversight and enforcement of laws designed to protect patient safety, which importation schemes undermine, there is increased potential for unsafe counterfeit, substandard or adulterated products to infiltrate the U.S. pharmaceutical supply chain, putting people in harm’s way.
Counterfeits may look like real medicines, but they can contain dangerous impurities like mercury, lead and even the powerful opiate, fentanyl. They may differ from the real thing in dosage or strength, their potency may be degraded, or they may not contain an active drug ingredient at all. Patients around the world, including in the United States, have died from taking contaminated fake medicines purchased online without a doctor or pharmacist’s supervision. The only vaccine or medicine you should take is one prescribed by your health care provider and dispensed by a licensed U.S. pharmacist.
Counterfeiting is a problem that never goes away. Most recently, the COVID-19 pandemic created new opportunities for criminal counterfeiters to take advantage of unwitting patients seeking prescription treatments and vaccines. Fake COVID-19 shots have been identified in Mexico and Poland, with one batch of “vaccines” containing anti-wrinkle cream. Police in China and South Africa seized thousands of doses of counterfeit COVID-19 vaccines in 2021 alone. The pandemic created a new space for criminals to take advantage of people, and criminal organizations are getting smarter and using social media to target potential victims.
In 2021, both the Drug Enforcement Administration (DEA) and Department of Justice (DOJ) issued alerts on the growing threat of counterfeit medicines. The DEA issued a warning about the rising number of counterfeit drugs containing a synthetic opioid in the United States. The DOJ caught a scheme that sold millions of dollars’ worth of dangerous prescription medications that were illegal to be sold in the United States. These imported drugs circumvented the FDA and involved fake companies and websites. These recent alerts reinforce that we should not be undermining the closed, FDA-regulated drug distribution system. As Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office stated, “When prescription drugs from outside FDA’s secure supply chain enter the U.S. marketplace, patients are put at risk.”
Despite this, personal, as well as wholesale, importation schemes are under consideration by some policymakers, which would make it easier for criminals to transport adulterated or counterfeit vaccines and drugs to unsuspecting consumers in the United States. In October 2020, the FDA published a final rule permitting commercial importation of certain drugs from Canada, the legality of which is the subject of a pending lawsuit brought by PhRMA, the Partnership for Safe Medicines and the Counsel for Affordable Health Care in U.S. District for the District of Columbia.
We must work to lower what patients pay for their medicines AND make sure patients are getting the medicines they need, safely. There’s a way to do both, but importing unsafe drugs isn’t the answer. Learn more about the dangers of importation.
Gabby Migliara
Why drug importation is bad for Americans
Infographic The Realities of Drug Importation from Canada
Infographic: The Realities of Drug Importation from Canada
When governments or individuals circumvent the regulatory gold standard of America’s medicine supply to acquire drugs from other countries outside of the United States’ secure drug distribution system – commonly referred to as importation – both individuals and the health care system suffer negative consequences. Without proper Food and Drug Administration (FDA) oversight and enforcement of laws designed to protect patient safety, which importation schemes undermine, there is increased potential for counterfeit, substandard or adulterated products to infiltrate the U.S. pharmaceutical supply chain, putting lives in harm’s way.
Infographic: The Realities of Drug Importation from Canada image
Medicine Safety
Fact Sheet
The Dangers of Drug Importation
Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, from Canada or elsewhere in the world, poses a serious risk to public health.
The U.S. Food and Drug Administration (FDA) is the gold standard when it comes to reviewing and approving drugs. Medicines that enter the United States through importation will not be subject to these same strong standards and, as a result, counterfeit, substandard or diverted, repackaged and adulterated drugs could be introduced into our secure drug supply chain.
The Dangers of Drug Importation image
Medicine Safety
Resource
Infographic How Medicine Purchased at a Canadian Internet Pharmacy Could Actually Be Fake
Infographic: How Medicine Purchased at a Canadian Internet Pharmacy Could Actually Be Fake
When governments or individuals circumvent the regulatory gold standard of America’s medicine supply to acquire drugs from other countries outside of the United States’ secure drug distribution system – commonly referred to as importation – both individuals and the health care system suffer negative consequences. Without proper Food and Drug Administration (FDA) oversight and enforcement of laws designed to protect patient safety, which importation schemes undermine, there is increased potential for counterfeit, substandard or adulterated products to infiltrate the U.S. pharmaceutical supply chain, putting lives in harm’s way.
Infographic: How Medicine Purchased at a Canadian Internet Pharmacy Could Actually Be Fake image
Medicine Safety
Fact Sheet