There is no Way to Regulate the Quality of Drugs Imported by American Patients

Brandon Macsata, courtesy POZ Magazine

This editorial by Brandon Macsata was published in The International Business Times on November 1, 2020. Macsata has been living with HIV since 2002, and serves as the CEO of the ADAP Advocacy Association, an organization that promotes the AIDS Drug Assistance Program and works to improve access to care.

How Drug Imports Can Endanger Patients

KEY POINTS

• There is no mechanism in place to regulate the quality of drugs imported by American patients.
• A 2017 study by the National Association of Boards of Pharmacy found that three-quarters of online pharmacies claiming to sell Canadian drugs actually sourced their products from places like India, Singapore, and Hong Kong, all major suppliers of counterfeits.
• The FDA acknowledges that it is "unable to estimate the cost savings" from President Trump's new plan.

I was diagnosed with HIV just shy of my 30th birthday. That day, everything changed. I was apprehensive about my prognosis, my treatment plan, and my ability to live a normal life.

Fortunately, medical advances have turned HIV from a certain death sentence into a manageable condition. Still, like all Americans who depend on complex medications to stay healthy, I worry about high drug prices, and this concern has only intensified amid the COVID-19 pandemic. Especially since some of the proposed "solutions" to high drug prices would put patients' health at risk.

Just recently, the Trump administration announced that it would allow states to import prescription medications from Canada with the aim of saving money for consumers. Doing so, though, could expose millions of Americans to counterfeit drugs, while achieving little in the way of savings.

I've seen firsthand how importation schemes can put patients at risk.

Shortly after learning I was HIV-positive, I ordered my anti-retroviral drugs from an online Canadian pharmacy. For two months, I received medications via mail without ever wondering where they were sourced or whether they contained the active ingredients I needed to keep me alive.

Then my doctor intervened. She told me that drugs purchased through online storefronts are often adulterated or counterfeit—in fact, the global trade in fake medicines is a $30 billion-a-year business. Unknowingly, I had been rolling the dice with my health.

There are two types of counterfeit drugs. The first contains potentially deadly substances—everything from arsenic to antifreeze. The second contains few, if any, active ingredients. Though pills in the latter category don’t contain actual poisons, they can be just as deadly. Anti-retroviral drugs have to be taken exactly as prescribed; missing even a few doses can allow the virus to reemerge.

There is no mechanism in place to regulate the quality of drugs imported by American patients. A senior official at Health Canada explicitly told the US surgeon general that her agency "does not assure that products being sold to U.S. citizens are safe, effective, and of high quality." The FDA, meanwhile, plainly states that it "cannot ensure the safety and effectiveness of drugs that it has not approved."

Moreover, drugs purportedly from Canada could come from anywhere. A 2017 study by the National Association of Boards of Pharmacy found that three-quarters of online pharmacies claiming to sell Canadian drugs actually sourced their products from places like India, Singapore, and Hong Kong, all major suppliers of counterfeits. Back in 2005, the FDA reported that only 15% of imported drugs marketed as Canadian actually originated in Canada. The other 85% came from "27 countries around the globe," meaning that many likely didn't go through rigorous quality control.

It's relatively easy to get hoodwinked by online pharmacies that promise quality drugs at bargain prices. CanadaDrugs.com, for instance, started out in 2001 as a seemingly reputable online pharmacy. But soon it turned to distributors outside of Canada to secure medicines. In 2018, a U.S. court prosecuted and fined the company for selling fake cancer drugs to American doctors.

Counterfeiters have shown they are willing to prey on people living with all kinds of diseases, including HIV. In 2011, a British regulatory agency discovered that two fake HIV medications had infiltrated the market and were circulating among patients.

Opening the door to drug imports would allow that kind of thing to happen here, putting us all at risk. And it's not even certain that legalizing importation would cut costs. The FDA acknowledges that it is "unable to estimate the cost savings" from President Trump's new plan. Former FDA Commissioner Scott Gottlieb wrote that "when importation of foreign drugs is done under a regulated scheme, it really wouldn't save money."

Right now, Americans are anxious enough about our health. Let's not add drug imports to our list of things to worry about.