By Mark O'Brien, Addiction & Policy Expert
Amidst discussions about how to increase access and affordability of prescription medicines, some regulators and policymakers at the federal and state levels have proposed opening the U.S. pharmaceutical supply chain to the legal importation of medicines. So far lost in the conversation is a critical aspect of the potential consequences of such a policy: its impact on the nation’s ongoing opioid crisis and mounting numbers of overdose deaths. At a time when the opioid crisis is growing rapidly, it makes no sense to begin importing potentially-counterfeit medications into the U.S. pharmaceutical market.
The truth is, the opioid crisis is not only getting worse; it has also entered a new phase in which synthetic opioids, often containing illegally-imported fentanyl, are driving the rising number of overdose deaths. According to the CDC, overdose deaths increased by 30% between 2019 and 2020 and another 15% between 2020 and 2021. Last year, nearly 108,000 Americans lost their lives to drug overdose. Over 65% of them, some 71,000 people, died from illegally manufactured fentanyl.
And the dangers of fentanyl are not limited to people who know they are taking opioids; public health officials and law enforcement have sounded the alarm about the growing presence of fentanyl in supposedly non-opioid illicit drugs as well as counterfeit medications designed to mimic the appearance of legitimate medications, including non-opioid medications. According to director of the U.S. National Institute on Drug Abuse Nora Volkow, over the last three years, “we have seen an increase of contamination of other illicit drugs with fentanyl, be it cocaine, methamphetamine, and more recently, illicit prescription drugs.”
The size of the problem is hard to comprehend. In one eight-week period in 2021, the DEA seized more than 1.8 million fentanyl-laced fake pills manufactured to look like legitimate opioid and non-opioid medications. The seized pills contained enough fentanyl to kill 700,000 people, enough people to fill the Baltimore Ravens NFL football stadium ten times. And the problem continues to grow. In 2021, DEA agents seized over 9.5 million fake medications, more than in the previous two years combined.
The damage caused by counterfeit medications has so far been limited largely to illicit sales of supposedly legitimate medicines. That’s because Americans are fortunate: according to the U.S. Food and Drug Administration (FDA), the “U.S. drug supply is among the safest in the world” because “medicine approved for use in the United States has been reviewed for safety, effectiveness and quality.”
But importing medications has the potential to introduce counterfeit medications containing fentanyl and other dangerous substances into the legitimate pharmaceutical supply on which American patients rely for their health. One study of foreign pharmaceutical markets concluded that “global legitimate medicine supply chain penetration by counterfeit medicines” is a major international public health challenge and that systems for monitoring the problem are insufficient to meet the challenge. In fact, the global trade in counterfeit medications has been valued at over $4 billion.
Even without legalized drug importation, the FDA already has its hands full trying to keep counterfeit medications out of U.S. pharmacies. It is no surprise that four former FDA commissioners who served under Presidents George W. Bush and Barack Obama sent an open letter to Congress in 2017 opposing drug importation, explaining that opening our pharmaceutical supply to imported medications would pose serious risks to patients and consumers by potentially introducing substandard, adulterated, or fake medications into the U.S. market with minimal cost savings or improvements to access. The FDA, they pointed out, is not equipped with the resources or expertise to monitor every product entering the country under proposed drug importation schemes.
Supporters of drug importation claim that we can keep our supply safe by importing from only “safe” countries like Canada and the EU. Yet, imported medications fall outside regulatory oversight in these countries, and they have had their own challenges with counterfeit medications. Simply put, drug importation from any market outside the U.S. dramatically increases the chances that fentanyl-laced counterfeit drugs will wind up in American pharmacies where unsuspecting patients will be at risk not only because they are not receiving the medications they need but also because fentanyl’s potency makes overdose or death more likely than with other adulterants.
As the opioid crisis continues to end too many lives too soon, policymakers in the U.S. should invest in efforts that can eliminate the unnecessary suffering and death caused by fentanyl brought into the country illicitly rather than opening the pharmaceutical market to make it easier for criminal organizations who prey on unsuspecting patients. That means investing in treatment and prevention, not increasing the risk that the next victim of opioid overdose death will have obtained a fatal poison at their local pharmacy.