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
Gabby Migliara is a director of Public Affairs at PhRMA focusing on internal communications and PhRMA’s digital presence, including maintaining this website and executive social presence. She previously worked with the U.S. Census Bureau on marketing and communications for the 2020 Census campaign. Outside the office, Gabby enjoys trying new restaurants, hanging with her cat and exploring D.C. neighborhoods.
More oversight needed of unapproved medicines that threaten patients’ health
What they are saying: Florida Drug Importation Program is Unfeasible and Dangerous
Florida’s importation plan puts patients in danger
Three things to know about the accelerated approval pathway
ICYMI: Antimicrobial resistance spotlighted as growing public health threat
PhRMA submits comments on FDA’s proposed rule on drug importation
Drug importation: An old idea that is still a bad idea
What they’re saying: Safety is top concern for recent drug importation proposal
ICYMI: Canadian government, stakeholders voice concerns with drug importation proposals
PhRMA responds to Florida’s request for information on drug importation
PhRMA CEO raises concerns with Florida importation proposal, highlights reforms needed to lower costs for patients
Look at the facts. Drug importation is dangerous.
Why state drug importation pilot programs don’t work
ICYMI: Wall Street Journal highlights dangers of counterfeit medicines entering the United States through drug importation
Securely dispose of your unwanted medicines on National Take Back Day
The Washington Post retracts PhRMA claim in opioid story
PhRMA response to Washington Post and 60 Minutes stories
VIDEO: PhRMA CEO discusses industry response to opioid crisis on Mornings with Maria
Protect your health: Important disaster preparedness tips for Harvey and Irma
PhRMA Supports President’s Commission’s Holistic Approach on Opioid Crisis
Opportunities to build upon enhanced competition for medicines in the marketplace
A critical opportunity to prevent prescription drug abuse
Former law enforcement officials raise concerns with drug importation proposals
The risks of counterfeit imported medicines
Resources for understanding the dangers of drug importation
ICYMI: What the experts are saying about importation
How drug importation schemes could increase U.S. law enforcement burdens
Case Study: How one online pharmacy knowingly endangered U.S. consumers
Why drug importation threatens patient safety
Fact Check Friday: The truth about drug importation and patient safety
What you don’t know about importation from Canada
Discovery of counterfeit hepatitis C drug is another example of why importation is bad for patients
Why drug importation is bad for Americans