DALLAS — An amendment proposed by Sen. Bernie Sanders, I-Vt., allowing for the importation of prescription drugs from Canada, needlessly puts both Americans and Canadians at risk of exposure to harmful and counterfeit drugs from foreign sources, and it creates economic incentives for bad actors to smuggle counterfeit or compromised drugs.
In a new publication from the Institute for Policy Innovation, “Prescription Drug Importation: Unsafe, Unnecessary and Unwise,” Merrill Matthews, Ph.D., says the Sanders amendment to the Prescription Drug User Fee Act (PDUFA), which is up for reauthorization in 2017, assumes what is virtually impossible to guarantee: that imported drugs would be safe, much less effective.
“According to the Sanders amendment, the secretary of the Department of Health and Human Services is supposed to police and enforce Canadian law on Canadian pharmacies located in Canada,” said Matthews. “Federal law already gives the HHS secretary the power to approve the importation of prescription drugs—as long as the secretary certifies the imported drugs are safe. To date, no secretary has exercised that power. Indeed, several have spoke out against such actions.”
Matthews explains that the Canadian government contracts with drug manufacturers for a limited supply of prescription drugs for its relatively small population. If Canadian pharmacies began exporting prescription drugs to the U.S. in large quantities, they would have to restock by purchasing inventory from foreign sources, which not only undermines Sanders’s notion the drugs are from Canada, but more importantly, exposes American and Canadian citizens to the risks from foreign-sourced drugs.
There is no need for importation, argues Matthews; the vast majority of Americans have prescription drug coverage, including the millions enrolled in either Medicare Part D or the Affordable Care Act, and insured consumers’ out-of-pocket costs would almost certainly be lower when buying through FDA-approved channels.
“The FDA struggles now to meet its obligations to ensure the safety and efficacy of prescription drugs being manufactured and sold to Americans without having to also become the guarantor of Canada’s pharmacies,” said Matthews. “Counterfeiting prescription drugs is already a big business, and the Sanders amendment opens the door even wider, giving the criminals who are involved in counterfeiting drugs a legitimate opening to the U.S. market.”
(Source: The Institute for Policy Innovation)