OP-ED: Unsafe crossing

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The issue of drug importation from abroad, particularly from Canada, continues to gain nationwide attention. The Department of Health and Human Services and the Food and Drug Administration issued the Safe Importation Action Plan, reportedly, to make prescription drugs more affordable via importation. Importation is also being explored in the states as a means to reduce drug costs by allowing cheaper drugs to enter our country. Will this really happen? And at what cost to the patient? Let’s discuss the facts.

First, importation will have a devastating impact on patient safety. There is no way to guarantee the safety of drugs that come into the country from outside the United States. Importation jeopardizes the health and well-being of patients.

Four former FDA commissioners who served under both Democratic and Republican administrations determined that it is not possible to certify the safety of imported drugs due to the inability to accurately trace the origins of foreign drugs, many of which are counterfeit and sold through internet pharmacies. They stated in an open letter to Congress on March 16, 2017 that importation “would likely harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.” In May 2018, the current Secretary of HHS, Alex Azar, dismissed importation as a “gimmick.”

Second, the United States is the gold standard for safety and effectiveness when it comes to regulating the safety of our medicine. Importing drugs from countries that do not have our same strong standards would put patients at risk and increase the potential for counterfeit or adulterated products to enter the U.S. with life-threatening consequences. Drugs coming through Canada may have originated anywhere in the world and have not undergone stringent FDA reviews.

The Partnership for Safe Medicines, a public health group consisting of 69 nonprofit organizations committed to the safety of prescription drugs and shielding consumers from fake, inferior or otherwise hazardous medications, strongly opposed importation. It noted that “the FDA has estimated that 99.1 percent of drug products entering the U.S. through international mail so far in 2019 are non-compliant with agency standards.”

Third, any cost benefit that might result from importation is likely to be minimal and will not significantly affect the overall issue of health care affordability. Much of the consumer savings from importing prescription drugs would be negated by the cost of policing such practices to ensure consumer safety. Furthermore, the majority of any savings would wind up as profits for middlemen, not lower prices for patients. The costs of implementing drug importation will outweigh any benefits lawmakers hope to achieve.

Former FDA Commissioner Mark McClellan stated in a Forbes interview that importation wouldn’t achieve its aim of providing cheaper drugs but would pose significant cost and safety problems. “That scheme would have added so much cost to the imported drugs, they wouldn’t be much cheaper than drugs sold inside our closed American system,” said McClellan. Importation will not lower out-of-pocket costs, but may put the health and well-being of patients at risk.

…the United States is the gold standard for safety and effectiveness when it comes to regulating the safety of our medicine.

The bottom line: BioNJ believes that importation of drugs from other countries is the wrong policy to address the U.S. health care affordability problem and more important, is dangerous to patients. Importation undermines the FDA gold-standard supply chain and will not achieve the anticipated savings to the U.S. health care system. Proposals to import pharmaceuticals, whether from Canada or elsewhere in the world, is not the answer.

BioNJ supports working on systemic reforms that improve the efficiency and competitiveness of the entire U.S. health care systems and not “gimmicks” that put patients at risk. These reforms should include moving away from the current fee-for-service payment model to value-based decisions that are patient-centered and provide high quality care for patients and the overall health care system.
While some states have introduced or approved importation legislation, New Jersey should not. We have the safest supply of medicines in the world and we cannot afford to risk that safety.

Debbie Hart is president and CEO of BioNJ.