Importing Drugs: Is It Safe and Responsible?

Purchasing prescription drugs imported from other countries has long been controversial. The allure of significant cost savings often fuels demand, while the potential health risks have driven legal restrictions and widespread government crackdowns over the years. But, whether these purchases are illegal or not, faced with the rising costs of pharmaceuticals, millions of Americans regularly buy drugs outside the U.S., typically online or while traveling abroad. In a 2016 Kaiser Health Tracking Poll, a whopping 80 percent of respondents said they or someone in their household had at some point imported a drug.¹ Another recent University of Florida study found 1.5 percent of adults — more than two million Americans — purchase their prescription drugs from outside the U.S. to save money.² And study researchers cautioned that numbers are likely to rise with the rapid growth in unemployment related to the COVID-19 pandemic and subsequent loss of health insurance for many Americans. “With the economic and health consequences of COVID-19 disproportionately impacting minority and low-income populations, more people in those groups may be seeking an alternative way to meet their medication needs,” said the study’s lead author Young-Rock Hong, PhD, MPH, an assistant professor of health services research, management and policy at the UF College of Public Health and Health Profession. 

Dr. Hong notes that in recent years, a number of proposals have been discussed as strategies to counteract increases in drug pricing. For example, last year, the Trump administration announced plans to allow importation of drugs from Canada in an effort to stimulate price competition. The U.S. Food and Drug Administration (FDA) also introduced the Safe Importation Action Plan, with proposed pathways to allow for the safe importation of drugs originally intended for foreign markets. If finalized, the plan would permit U.S. consumers to purchase certain drugs from Canada. But the question remains: Is it safe? 

Counting the Cost of Counterfeits

Many people assume if drugs are imported from a highly developed neighbor like Canada that safety risks will be minimal. But experts say not necessarily. While Canadian regulators ensure the safety and authenticity of medicines entering their market and intended for use by Canadian patients, they do not apply those same standards for medicines intended for export only. In a statement on the topic, the Canadian government said, “Health Canada does not assure that products being sold to U.S. citizens are safe, effective and of high quality, and does not intend to do so in the future.”²

According to FDA reports, while nearly half of imported drugs claim to be Canadian or from Canadian pharmacies, 85 percent of such drugs were actually from different countries. Given that drugs imported from abroad lack oversight by any health authority, there is a high likelihood such drugs — if not counterfeit — could nonetheless be mishandled or could display deceptive or incorrect packaging and labeling.³

The World Health Organization (WHO) conservatively estimates one in 10 medications sold in the world is substandard or falsified. According to a report by WHO, 10 percent of drugs worldwide and approximately 50 percent consumed in developing nations are counterfeit.⁴ One of the challenges is that in the absence of FDA’s oversight and proper enforcement of laws developed for patient safety, which is undermined by drug importation, these products could easily infiltrate the pharmaceutical supply chain, with potentially life-threatening consequences. FDA has repeatedly stressed it cannot ensure the safety of imported drugs, which begs the question from a patient perspective: Is the cost savings worth the risk?

Here are some important considerations:

• Evidence suggests some drugs shipped to the U.S. from Canada have their origins in other countries with amenable regulatory systems like Pakistan and Bulgaria. 

• Counterfeiters are getting more sophisticated with their technology. In 2015, for example, a Canadian online pharmacy was fined $78 million for conspiring to allegedly smuggle unapproved and mislabeled prescription drugs into the U.S.⁵ That same year, FDA and Interpol confiscated fake drugs from as many as 1,000 websites.⁶

• According to The Alliance for Safe Online Pharmacies, there are at least 35,000 illegal online pharmacies at any given time that do not comply with laws and pharmacy standards.⁷

• Imported medications and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness in the U.S. These products may be addictive or contain other dangerous substances.

• The medication’s label, including instructions for use and possible side effects, may be in a language individuals do not understand, or the label may make medical claims and suggest specific uses not adequately evaluated for safety and effectiveness.

• An imported medication may lack information that would permit someone to be promptly and correctly treated for a dangerous side effect caused by the drug.

The Skyrocketing Cost of Prescriptions

In data analyzed from a 2015-2017 National Health Interview Survey, participants were asked if they had purchased prescription drugs from countries outside the U.S. to save money. Those who had were more likely to be older, be an immigrant and have inadequate insurance coverage and financial constraints that impact their ability to refill prescriptions. They were also more likely to use the Internet for healthcare information.1 “Patients might not be getting what they think they are getting,” said the UF study’s co-author Juan Hincapie-Castillo, PharmD, PhD, an assistant professor of pharmaceutical outcomes and policy in the UF College of Pharmacy. “This is particularly dangerous to patients needing medications with a narrow therapeutic index. In other words, a medication with a small dose deviation can result in severe adverse events.”¹

Still, many believe the risk is worth the cost savings. Amanda Mazumder, a 27-year-old graphic designer in St. Paul, Minn., began buying birth control pills online when she became frustrated by the cost of her prescription. She couldn’t afford to pay $150 a month for her birth control, but found an online Canadian pharmacy that sold her a three-month supply for $60. And, Los Angeles resident Bobby Grant has relied on foreign pharmacies for years to get medicine for his partner’s severe asthma. Grant travels internationally for his job, and each time he’s in Mexico or France, he buys 10-packs of inhalers and 20-packs of nebulizer solution for a fraction of what they would cost in the U.S. — medications costing $300 a month if purchased here. Grant estimates he saves at least $2,500 a year by buying the drugs overseas.⁸

Mazumder and Grant are far from alone. Research shows people who have imported medicines range from college students in their 20s to retirees in their 80s. Their purchases include medications to treat chronic conditions — such as high blood pressure and thyroid problems — and acute problems such as sinus infections and acne.

Of course, safety isn’t the only concern for people who purchase drugs from other countries. According to FDA, it is illegal for Americans to import drugs into the U.S. for personal use. The law isn’t rigorously enforced, in part because it is difficult to monitor the entry of medicine in suitcases and small packages. But, in 2015, FDA implemented a rule that would give government border inspectors expanded authority to destroy drugs imported for personal use at their point of entry. Yet, as Mazumder and Grant prove, when people are desperate, they are willing to risk breaking the law.⁸ “The reality is that literally millions of people get their medications this way each year, and they are either saving a lot of money or they are getting a drug they wouldn’t have been able to get because prices are too high here,” says Gabriel Levitt, president of PharmacyChecker.com, an online company that allows people to compare prescription drug prices among international and U.S. pharmacies.⁹

For people with diabetes, for example, the inability to pay U.S. prices for insulin can be a matter of life and death, which is why so many families look to Canada or Mexico and are willing to break the law if it means staying alive. Robin Cressman, who was diagnosed with type 1 diabetes in 2012 and has become a vocal advocate for lower drug prices, says even with insurance, she was paying $7,000 a year out of pocket for the two insulin drugs she needs: Lantus and Humalog. At one point, her credit card debt hit $30,000. Then, while on an outing in Tijuana, Mexico, she popped into a few pharmacies to see if they stocked her medications. With little fanfare, she says, she was able to buy both drugs over the counter for less than 10 percent of what they cost her at home. “I left Tijuana that day absolutely trembling because I could not believe how easy it was for me to get my insulin,” she says, “but also how little money it cost and how badly I was being extorted in the U.S.”⁹

Colorado First of Several States to Pioneer Drug Importation Program

In January, Colorado became the first state to formalize a prescription drug importation program. “We’re a pioneering state,” said Kim Bimestefer, head of Colorado’s Department of Health Care Policy and Financing. “We lead. We’re not shy about being first into the gate and figuring this out. We want to bring the savings to Colorado.”¹⁰

Bimestefer’s department is in charge of creating the importation program and is soliciting bids from Canadian wholesalers to purchase drugs for the Colorado market, as well as importers to package and distribute the drugs. The state will also hire a company to handle administration of the program, including compliance monitoring. It hopes to have all three vendors in place by fall 2021. “We’re confident that what we’re putting together works within the guidelines established by Canada,” Bimestefer says, adding that the financial savings for Colorado are in brand name drugs. Her department compared the cost of 50 popular drugs in Colorado with the cost of the same drugs in Canada and found Coloradans pay, on average, 63 percent more. “Our consumers and employers are paying 20 times more the price than Australia is for the same thyroid medication. That’s not OK. So, we want to take the same drugs, with the same FDA approval, and just bring them in through a different pathway that allows us to bring so much more savings.”

The state’s plan is to hire a wholesaler, importer and compliance vendor by this fall and begin importing drugs from Canada, and possibly France and Australia, by 2023. Bimestefer says the draft proposal the state sent to the federal government (which will have final say) includes at least 167 drugs.

Colorado is not alone in its efforts to formally launch an importation program. Florida, Vermont, New Hampshire and Maine are also moving ahead with plans to import prescription drugs from Canada, a strategy approved last year by former President Donald Trump.11 While it remains unclear whether the Biden administration will support the proposed plan, Trish Riley, executive director of the National Academy for State Health Policy, said states have worked hard to set up procedures to ensure drugs coming from Canada are as safe as those typically sold at their local pharmacy. She noted that many drugs sold in the U.S. are already made overseas.

Riley acknowledged the Biden administration could choose not to defend the importation rule in the Pharmaceutical Research and Manufacturers of America court case or ask for an extension to reply to the lawsuit. “Right now, it’s murky,” she said of figuring out what the Biden team will do.¹¹

Discussion and Policy Changes Are Needed

Clearly, more discussion and policy changes are needed, including a willingness by all stakeholders to address the root causes and issues surrounding unaffordable medication costs. With more Americans anticipated to purchase prescriptions outside the U.S. in the coming months and years, patient education and stringent quality control measures are more important than ever. “Patients should be informed of the potential risks they can encounter,” Dr. Hong said, “and policies that seek to pursue drug importation should reinforce quality assurance and strict monitoring processes to promote safe administration of imported medication in the U.S. market.”¹