As Congress considers including the issue of prescription drug importation as part of the Food and Drug Administration’s drug and device user fee reauthorization legislative package, one principle central to this long-running debate still holds true: drug importation simply does not work as a matter of safety and practical policymaking.

Our country has the world’s safest drug supply, and this is not because of luck or happenstance. The FDA regulates the manufacturing and distribution of medicines in the U.S. throughout the extensively long distribution chain. The FDA does not inspect or approve drugs that are intended to be sold in Canada, just like they don’t inspect or approve drugs that are intended to be sold in Europe, China or Brazil.

Importing drugs from other countries that are not subject to rigorous FDA standards and allowing them into the U.S. drug supply would be tantamount to eliminating current consumer protections.

Even the real medicines from other countries would have no FDA testing for safety and written materials, such as consumer information and warnings. These foreign drugs may have different chemical or biologic makeup, require special handling (in regard to temperature, light, etc.), and have not had clinical data, labeling or manufacturing operations reviewed by the FDA. Undermining the security of our system with these drugs would constitute a significant mistake.

Counterfeit medicines are proliferating around the world, and those responsible for this dangerous, abhorrent practice excel at making these products look just like the real deal. The COVID-19 pandemic has only added to this by necessitating access to vaccines, therapeutics and personal protective equipment at a scale that has rarely been seen in history.

Two years into the pandemic, we asked 3 questions: Does a mask work? Does social distancing work? Can you get COVID-19 from a surface?

With the unprecedented demand has come opportunities to counterfeit pharmaceuticals and other equipment that the public desperately need. The FDA keeps a rolling tally of counterfeit at-home over the counter COVID-19 tests that have been discovered, as well as other fraudulent COVID-19 products.

Interpol and the Organization for Economic Cooperation and Development — an intergovernmental organization of 38 member countries that the U.S. is a part of — have highlighted the global rise in COVID-19 related counterfeit medical products including face masks, hand sanitizers and antiviral medications. During one week, Interpol seized 4.4 million units of counterfeit pharmaceuticals, along with more than 37,000 counterfeit medical devices.

In a report in 2020, OECD also estimated the total value of counterfeit pharmaceuticals traded worldwide to be as much as $4.3 billion. With so many counterfeit products available, the U.S. should not expose its residents to the dangers of false chemical compounds or dangerous placebos that could cause irreparable damage or death.

The pandemic has also shed an important light on our country’s mental health and substance abuse crisis.

The Centers for Disease Control and Prevention recently reported that in 2021, there were 107,622 drug overdose deaths in the U.S., an increase of nearly 15%. Most of these overdose deaths were caused by synthetic opioids, including fentanyl. While the mental health and substance abuse crisis — and the tragic deaths that have occurred because of it — deserves its own specific policy solutions, we cannot discount the possibility of what would happen if the U.S. were to open its drug supply chain to products that regulators cannot confirm are 100% safe.

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I am one of many health and human services secretaries who found it impossible, based on the preponderance of evidence and data before me, to certify that importation of medicines from unregulated sellers is safe. In fact, my predecessors and successors from both political parties, along with multiple FDA commissioners, have consistently found that drug importation carries potential dangers that cannot be ignored.

Guest opinion: Coronavirus reveals need to rebuild USA-made medicine production

The dangers and factors further exacerbated by the COVID-19 pandemic and associated crises have only solidified my belief that the importation of medicines is not the direction that the U.S. should go.

Instead of looking at importation and putting the health and safety of our country at risk, Congressional leaders should take a step back and assess why the people who’ve seen the consequences of importation firsthand continue to remain opposed.

Michael Leavitt is the former governor of Utah and former secretary of health and human services.

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