Too Good to be True: Drug Importation

“Never let a good crisis go to waste.”

Most famously attributed to Winston Churchill (or Saul Alinksy, depending on which rumor you follow), this phrase is as apt for politicians, activists, and scam artists alike. In general, the former two groups mean “seize an opportunity to move forward an agenda,” while the latter focuses solely on personal gain at a cost to the well-being of others. There are few more fertile fields for those scam artists to seize the moment than counterfeit products. The United States has worked hard to combat counterfeit scams across a variety of industries on international, federal, and state levels: forming investigative agencies, imposing high fines, and establishing consumer protection and reporting entities charged with receiving complaints and notifying the public of fake and potentially harmful consumer items.

The COVID-19 pandemic offered a fresh chance for a scheme that gained notoriety in the 1980’s: fake medicines. For much of the United States, COVID-19 became “real” on March 13th, 2020. As soon as March 19th, the FBI issued warnings over fake testing kits, making the problem of fake medicines, treatments, cures, tests, and even personal protective equipment (PPE) a front-and-center issue in the fight against COVID-19.

Counterfeit medicines have long plagued the chronic illness space. From insulin and cancer medications to anti-retrovirals and hepatitis medicines. Notably, the FDA participates in Interpol’s Operation Pangea, a global effort to crack down on counterfeit medicines and collaborative work to ensure supply chain safety. Operation Pangea specifically targets illicit websites claiming to be “pharmacies”. In 2017 alone, the collaborative work resulted in more than 400 arrests and the seizure of more than $51 million in potentially counterfeit drugs.

Despite nearly three decades worth of work fighting this dangerous practice, it continues to plague patients, their families, and our communities. While not as much a news item these days, counterfeit opioids remain an issue, having resulted in at least 42 deaths in the United States this year. As recently as December 23rd, 2020, manufacturer, Janssen, issued an alert regarding counterfeit Symtuza and, in July, the Department of Justice secured admissions in federal court on a pair of men pushing fake cancer and hepatitis treatments.

The problem is growing. In 2018, Operation Pangea identified and took down 465 websites illegally selling potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers. It’s not just direct consumers these potentially dangerous actors target, the FDA sent a warning letter in 2019 to CanaRx, an entity that contracts with self-funded health care plans.

Most disturbingly, despite many of these online websites masking themselves as “Canadian pharmacies”, in the waning days of the Trump administration, HHS has issued a final rule that would allow states, tribes, pharmacists, and wholesalers to import medications from Canada. While already facing legal challenges from industry and advocates, the final rule does not outline specific measures of safety – rather it forces states and manufacturers to take on the cost of ensuring a safe drug supply – and does not point to any specific evidence importation will reduce costs to consumers.

The issue of defending (or not) or further defining the rule will fall squarely on the shoulders of the Biden administration as the legal and logistical challenges work their way through their respective processes.

The American drug supply already faces an uphill battle to remain safe in an ever-evolving environment with increasingly sophisticated and predatory bad actors. Those most vulnerable to exploitation are not served (and the dangers of counterfeit medicines are not diminished) with unproven notions and a lack of safeguards. Whether in treatment of disease states with which we are long familiar or in the case of a novel virus, the American public deserves both to be able to afford their medications and to trust them.

For providers, BeSafeRX, an FDA resource page.

For patients seeking assistance in affording your medications, PAN Foundation may be able to help.