As the Trump administration turns its focus to shutting down the fentanyl trade, legislative efforts in Congress could make the crisis worse.
Opioids and counterfeit medicines are killing Americans at astonishing rates. Yet some in Congress have renewed their push to begin importing medicines from other countries, undermining law enforcement’s efforts against drug trafficking and counterfeiting threats to our homeland, and endangering the health and safety of citizens.
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Under the current rules, no drug imports are allowed unless the Secretary of Health and Human Services can certify that they “pose no additional risk to the public’s health and safety” and will result in a “significant reduction” in cost to the consumer. To date, no secretary has made that certification. A new importation scheme would upend these protections and put consumers at risk.
While many Americans are concerned about the high cost of prescription drugs, this regulatory arbitrage — selling medicines imported from markets with price controls — is not just bad economics. It also creates another pathway for illicit drugs to enter the United States, a pathway that needs to be monitored, inspected and guarded against with finite law enforcement resources. Today, those cops on the beat have their hands full.
Evidence shows that the traffickers have already been lacing prescription opioids like Oxycodone with fentanyl, a deadly opioid 50 times more powerful than heroin, that is smuggled from China and can kill people in tiny doses. Enough fentanyl to kill 32 million people was recently seized in a single bust in New York City. And machines used to make counterfeit pills are reaching the U.S. border in record numbers: Customs and Border Protection recorded a 141 percent increase in pill press seizures from 2014 to 2016.
Enough fentanyl to kill 32 million people was recently seized in a single bust in New York City.
The world of legal and illegal drugs often collide. While many Americans are aware of the risks posed by fentanyl and opioids, the $200 billion global market in fake medicines is surging here in the U.S. These fake medicines have been found in legitimate supply chains and rogue online pharmacies, or accessed through illicit importation channels or smuggling operations (procured illegally or produced illicitly in other countries and entering Mexico or Canada).
Counterfeit medicines pose a serious risk to public health and safety when fake medicines infiltrate the U.S. pharmaceutical supply, and when consumers who are treating heart disease, cancer, high cholesterol, hepatitis C, erectile dysfunction, and other health ailments purchase them.
A telling example came in August when FDA Commissioner Scott Gottlieb toured operations at the agency’s JFK Airport mail facility and tweeted pictures of “just some of thousands of seized fake, controlled-drug packages.”
So, while it sounds counterintuitive, importing legitimate medicines actually creates a risk in the illicit drug market by providing new financial incentives for the Mexican cartels and Asian syndicates — which are already exploiting weaknesses in the system — to produce and distribute fake counterfeit drugs through their vast smuggling networks.
A report by former FBI Director Louis Freeh found an “overwhelming consensus” among law enforcement that a drug importation scheme would “fuel criminal organizations’ activities and profits … turn[ing] the advantage from law enforcement to criminal organizations.” The National Sheriffs Association argued in a July resolution that drug importation “would worsen the opioid crisis, open up the U.S. pharmaceutical supply chain to adulterated and counterfeit drugs, further burden law enforcement, and endanger the safety of officers and other first responders.”
But supporters in Congress have so far ignored these national security concerns. Over the objections of law enforcement, they continue to try to attach amendments allowing drug imports to Senate must-pass legislation. Senators from both parties tried to add such an amendment to the Senate budget bill last month.
I concur with the Freeh report that current importation proposals would “force law enforcement agencies to make tough prioritization decisions that leave the safety of the U.S. prescription drug supply vulnerable to criminals seeking to harm patients.”
A public-health crisis of this magnitude calls for a timeout in the drug importation debate in Congress, in order for lawmakers to become better informed on the breadth and scale of the webs of corruption and criminality involved in today’s illegal trade of pharmaceuticals. Until the Trump Administration reins in the illegal fentanyl trade — last month it scored a significant victory with its first-ever indictments of Chinese manufacturers of killer fentanyl operating in the United States — we need to have a more informed debate in Congress about the harms that opioids and fake and counterfeit medicines pose to Americans.
David M. Luna is president and CEO of Luna Global Networks & Convergence Strategies LLC and the departing chair of the OECD Task Force on Countering Illicit Trade. He is the former senior director for National Security and Diplomacy, Anti-Crime Programs, Bureau of International Narcotics and Law Enforcement Affairs at the U.S. Department of State.