The FDA recently approved Florida’s proposal to import drugs from Canada despite concerns over safety and available supply in Canada.
In the middle of a heated presidential campaign, perhaps the political calculations outweigh evidence that importing drugs from Canada, or anywhere else for that matter, is the silver bullet that will immediately bring down the price of prescription drugs.
Federal law states that drug importation can only be allowed if there is “no additional risk” to safety and will “result in a significant reduction” in the cost of drugs. By any reasonable measure, Florida’s plan fails on both counts.
At least 24 U.S. Republican senators and nine conservative organizations have spoken out against importation. These voices understand that importation would drastically undermine patient safety by opening the floodgates to counterfeit drugs, which is estimated to be between a $200 billion and $432 billion a year industry globally.
This isn’t theoretical. The chorus of pro-importation voices are already undermining safety. According to the National Association of Boards of Pharmacy, nearly three-quarters of the online pharmacies that claim to be Canadian actually source their medications from outside of Canada where regulations are even less stringent. All the while some trumpet the benefits of Canadian prescription drugs, criminal enterprises have taken advantage by marketing counterfeit drugs online as “Canadian” to unsuspecting consumers.
Importation would make this trend far worse by potentially legitimizing fake drugs. In our current secure supply chain system, the FDA is able to effectively monitor and track the movement of medicines and root out fraud. Thanks to their supervision, it is far more difficult for counterfeit drugs to infiltrate licensed U.S. pharmacies and existing cases largely take place outside legitimate channels. Importation would put the stamp of approval on less regulated or entirely unregulated sources from all across the world as long as they at one point make their way through Canada. That should be a pretty terrifying thought for consumers.
In recent years, the fentanyl crisis has shown the destructive impact that counterfeit drugs can inflict on communities. As fentanyl overdoses continue to climb at alarming rates, these preventable deaths are increasingly caused by ingestion of counterfeit pills. Stories of accidental overdoses have become far too common as a result of counterfeit drugs. It should go without saying that policymakers shouldn’t do anything to make them more ubiquitous.
To add insult to injury, undermining the safety of our supply chain and trust in our healthcare system would come with little to no cost benefit to patients. Past FDA analyses have found that many American generics are already cheaper than Canadian generic drugs. And, Canada’s existing drug supply is only enough for its much smaller population, representing only 2% of global pharmaceutical consumption as opposed to 44% for the United States. Canadian officials have made it clear that they have no intention of letting this limited supply be shipped to the United States should there be any threat of shortages.
As of now, eight other states have submitted or are pursuing similar plans as Florida. All of them are based on the same false assumptions. As there is no federal law in place, the federal government cannot open the door to a complicated patchwork of 50 different state importation programs. Though these states are right to be concerned about the cost of medicines, importation presents a potentially dangerous and counterproductive approach.
There are ways to address the cost of medicines, particularly for those most vulnerable. However, misleading Americans about the impact on prices and potentially compromising patient safety by importing drugs of untraceable origins shouldn’t be one of them.
By Mary Bono
The Honorable Mary Bono is the Chairwoman of Communities United for Smart Policy and a former member of the U.S. House of Representatives for California.
Tags: Drug Importation New Drug Trends Safety Alert Supply Chain
