Drug importation endangers U.S. patients by breaking our closed, secure drug supply
Who Sells Counterfeit Medicines?
Drug traffickers all over the world sell unreliable, and sometimes toxic, look-alike products to patients who suffer because their illlnesses go untreated, or because they are poisoned. In some parts of the world as much as 30% of the drugs on the market are fake. The cost of this trade is unimaginable: fake drugs cost 100,000 lives a year in Africa alone.
Are There Counterfeit Prescription Drugs in the U.S.?
- Every state in the country has had a counterfeit drug incident since 2010.
- As of February 2019, authorities in 46 states have found counterfeit prescription pills made with deadly fentanyl or fentanyl analogues in circulation.
- In 2012, the FDA discovered imported cancer treatments that contained no active ingredient in the American drug supply.
- Between 2012 and 2016, the FDA warned more than 3,000 medical practices to stop buying medicine from unlicensed foreign pharmacies.
How Can Drugs From Canada and Europe Be Dangerous?
Drug importation supporters believe that drugs purchased from “safe” countries such as Canada and Britain are made for residents of those countries, and are subject to strict regulations and oversight.
This is not true.
Imported prescription drugs fall outside of regulation in other countries. The drugs that Canadian online pharmacies sell Americans, for example, are not the same as the ones Canadians take. They are usually from other countries. Canada has been explicit that "Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.”
Can't We Make Imported Drugs Safe By Keeping Track of Where They Come From?
No. Importation undermines our core efforts to keep our medicine supply safe. State and federal authorities regulate every entity in the U.S. supply chain from the point of manufacture until a medicine is dispensed, and that makes counterfeits in the legitimate supply chain rare. In 2013, Congress passed the Drug Supply Chain Security Act to make the supply chain even stronger, and the U.S. began a ten-year project to implement it. This system (also referred to as "track and trace" and "e-pedigree") only works as well as the entities participating in it fear regulatory enforcement.
Allan Coukell, Senior Director of Health Programs at the Pew Charitable Trusts explained how importation would compromise the safety of the U.S. pharmaceutical supply chain in February 2017. The Healthcare Distribution Alliance (HDA), a national organization that represents pharmaceutical distributors, agrees. Their infographic, Imported Medicines, At What Cost?, offers a brief take on why importation and track and trace are incompatible.
What do healthcare, law enforcement, and medical safety experts think about importation?
- Every head of Health and Human Services and the FDA since 2003 has refused to certify the safety of drug importation. Many have explicitly criticized the proposal as unsafe, unimplementable, and unlikely to save money.
- Since 2000, dozens of organizations including regulators in both the U.S. and Canada, law enforcement groups, and patient groups, and healthcare professional organizations have penned countless statements pointing out the dangers of drug importation.
- Former FBI Director Louis Freeh published a 2017 report finding that drug importation would overwhelm the safety mechanisms already in place to protect Americans. Importation, he found, 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."
Canadians Think That Americans Ordering Medication From Canada Is A Bad Idea.
The list of issues with Americans ordering from the Canadian drug supply is legion.
First, it's unlikely we can actually get medicines out of their domestic drug supply. Canada does not prosecute people who put up fake Canadian web pharmacies so those sites abound online—but if we actually did try to get Canadian domestic drug supply, it's not legal for their pharmacists to dispense to us. Three different Canadian pharmacy regulators recently said this is not allowed under Canadian licensing.
Canada doesn't have enough medicine supply to start filling our prescriptions. PSM's board member Marv Shepherd researched this and estimated that if 20% of U.S. residents started purchasing their medications from the Canadian drug supply, they would strip Canada's name brand drug supply in 201 days.
These same concerns were also brought up in recent letters from Canadian patient groups as well as pharmacy regulators from the Canadian provinces of Manitoba and Newfoundland and Labrador. Even the association that represents pharmacy boards all across Canada weighed in on the fact that this is illegal.
Are these drugs really hurting people? Yes.
- As of February 2019, people in 29 states have died because they accidentally took counterfeit prescription painkillers or fake Xanax.
- Counterfeit medicines have reached patients like Betty Hunter, who died of lung cancer without knowing that her physician had treated her with illegally imported drugs.
- The Partnership collects examples of patients harmed by these drugs on our Counterfeit Drug Victims page.
Can't We Stop These Killers?
Stopping the counterfeit medicine trade is difficult and time-intensive. Customs and Border Protection and U.S. Postal Service inspectors need more staff and better tracking technology to catch illegitimate medicines being imported into the country. Forensic laboratories need the time and money to test medicines and identify the cause of unexpected deaths Law enforcement needs to be able to investigate drug smugglers working in our country and across borders–and then they have to extradite foreign distributors if they want to prosecute them. This has proven difficult.
- The FDA discovered that CanadaDrugs.com had sold fake Avastin to American oncologists in 2012. The Department of Justice indicted six Canadians for selling the medicine in 2014. For over three years, the United States attempted to extradite the ringleaders from Canada. In 2018 they gave up and allowed them to plea bargain their case in exchange for a fine and probation. No jail time was served by any of the indicted individuals. The CEO did receive five years probation, but he was not required to relinquish his pharmacist's license.
- When the U.S. prosecuted RxNorth founder Andrew Strempler for falsely claiming that the unregulated prescription medicines he sold Americans met U.S. safety standards, they had to persuade Panama to deport him, and then arrest him in the Miami airport during a flight layover.
A 2017 legal review found that the penalties for foreign drug distributors violating prescription drug safety laws, the penalties are inadequate. After analyzing more than 100 criminal cases related to fake Internet pharmacies, the writers concluded that "current legal tools and regulatory policies do not effectively deter this highly profitable criminal activity."
How Can We Protect Americans?
Only Buy Drugs from Licensed U.S. Pharmacies.
PSM maintains resources to educate patients about the risks of importation. Americans can save money safely by taking generic drugs when appropriate, comparing prices among licensed U.S. pharmacies, and pursuing patient assistance programs.
FBI Director Louis Freeh on the impact of importation on law enforcement (July 14, 2017)