Proposed Bill Could Fuel the Opioid Epidemic

George M. Karavetsos’ editorial was published in The Hill on October 30, 2017. George M. Karavetsos is a partner with the global law firm DLA Piper. He formerly served as the director of the U.S. Food and Drug Administration's Office of Criminal Investigations and chief of the Narcotics Section and the executive assistant U.S. attorney in the Southern District of Florida.

Proposed Bill Could Fuel the Opioid Epidemic

Consumers better think twice before clicking "purchase" on an internet pharmacy's site.

The International Police Organization and regulators and law enforcement from around the world just conducted a major sweep of online pharmacies. Over the course of one week in mid-September, INTERPOL seized more than 25 million illicit and counterfeit medications, or $51 million worth, and made 400 arrests worldwide. It also shut down more than 3,500 illegal online pharmacies, including some selling pain pills laced with fentanyl. Illegal trafficking and abuse of this powerful opioid is killing tens of thousands of teenagers and adults in the United States each year.

This operation demonstrates how easily consumers can purchase millions of dangerous and deadly drugs through illegal online pharmacies.

At a time when federal regulators and law enforcement have the nearly impossible daily task of detecting and intercepting hundreds of thousands of packages containing these dangerous counterfeit drugs, some members of Congress are proposing drug importation legislation that would allow Americans to purchase drugs from foreign, unregulated pharmacies.

Though it may seem well-intentioned, this proposed legislation ignores the realities of the public health crisis America faces today. If enacted, it will also inevitably increase the number of lives that will be lost.

Consumers access many of these pharmacies online. They believe that they are ordering drugs from reputable foreign pharmacies. But they aren't.

Consider the numerous entities that claim to be "Canadian" online pharmacies. Only a tiny percentage of these pharmacies actually are licensed in Canada. Most fraudulently use the Canadian name to legitimize their activities.

In fact, 96 percent of online pharmacies operate illegally, selling drugs without a prescription or distributing counterfeits. This puts the public's health at great risk.

Many of these counterfeit medications fuel the U.S. opioid epidemic. Counterfeiters will turn a few thousand dollars into $10 million by buying fentanyl powder — often purchased from Chinese labs — and a pill press online.

They'll then make a drug and pass it off to our teenagers and adults as legitimate versions of other non-fentanyl, pain pills. These unsuspecting victims will then take the drug, overdose and die.

Should Congress' proposed importation legislation pass, there would be no regulatory mechanism to distinguish between legitimate and counterfeit imports. Consumers will have no idea if they are receiving a drug that is safe and effective or a counterfeit that could kill them.

One thing is certain: With a direct pipeline to American consumers, criminal organizations will tap into other, less regulated global drug markets to ramp up the size and scale of their illegal pharmacy operations.

Their goal? Pump as many drugs as they can into the United States.

These drugs won't be coming from vetted sources. Illegal online pharmacies source their drugs from countries like China, which is the number one supplier of fentanyl to North America, according to the U.S. Drug Enforcement Administration.

There are other types of counterfeits being made overseas, too.

In 2014, for instance, Polish police arrested 14 suspects for manufacturing counterfeit Viagra and selling it online. Last year, officials charged a Belgium man for creating falsified U.S. labels for drugs manufactured in India. This spring, officials discovered a counterfeit cancer medication in Germany's supply chain. And over the summer in France, Denmark and Mexico, officials intercepted counterfeit versions of an injectable drug used to treat children's growth deficiencies — the counterfeit contained no active ingredients.

Unfortunately, the prevalence of counterfeit drugs in foreign drug supply chains is not a new problem. Over the course of just two months in 2009, European officials seized 34 million counterfeit pills.

America's strict pharmaceutical laws and regulations have helped to keep our country's drug supply safe from such massive injections of counterfeit medications and opioids.

Easing up drug importation regulations with Canada and Europe would counteract every effort that Congress and federal authorities have made to protect the American public and keep illicit drugs out of the country

The ban on foreign drug imports exists for good reason. Lifting it will make it harder for America to keep counterfeit and illicit drugs out and cost many Americans their lives.