Importing opioids for the purpose of drug abuse is not the same thing as importing lifesaving medication, and it is critical that regulators treat them differently — and the law strongly encourages them to do so.
Since 2018, taxpayer funding for Food and Drug Administration activities has increased substantially for the purpose of stopping illegal opioids from coming into the country through international mail facilities. With that convenient window dressing, those taxpayer dollars and new federal laws are now being used to take away prescription drug orders at those same international mail facilities, which are often placed by patients who cannot afford them domestically.
This misuse of the opioid crisis is the product of lobbying and public relations campaigns funded by the pharmaceutical industry and its big pharmacy allies: Companies which bear the most responsibility for the approximately 500,000 opioid deaths in America. In contrast, the government has never reported a single death or even serious adverse reaction due to a person with a valid prescription importing their prescribed medicine.
Americans continue to buy medications internationally because, as reported by the RAND corporation last year, brand name drugs are, on average, 75 percent cheaper outside the U.S. I hope to see drug prices lowered here in the U.S. this Congress, but it’s imperative that safe personal importation remains a viable lifeline for those slipping through the cracks of our broken healthcare system.
I know this subject matter inside out because my company, PharmacyChecker, verifies the legitimacy of international online pharmacies for the safety of patients who choose to fill their prescription orders internationally. Properly credentialed international online pharmacies require valid prescriptions and don’t sell opioids or any controlled drugs internationally. People who find legitimate online pharmacies may find a lifeline of affordability for their non-controlled prescribed medications. Those seeking opioid drugs from foreign countries with or without a prescription will be highly disappointed.
It’s well known that cost-related prescription non-adherence (people skipping or rationing medication because of a daunting price tag) leads to thousands of hospitalizations and deaths each year. Annually, about 2.3 million people in the U.S., with a prescription from their providers, import medicine to treat chronic conditions such as asthma, cancer, diabetes, heart disease, and HIV. Under most circumstances, drug importation is technically prohibited, except where the manufacturer authorizes it. However, the law states that the FDA “should” use enforcement discretion to permit importation by individuals for their own use as long as the import does not pose “unreasonable risk” to them. Recent history shows that the FDA may be going in the opposite direction by intentionally not allowing international prescription orders to reach the patients waiting for them.
That’s why I was concerned to read about even more proposed funding for stopping “opioids.” Last month, a report voted out of a U.S. Senate Appropriations subcommittee stated that “[the] Committee remains concerned about the opioid epidemic that has taken the lives of thousands of Americans. The Committee provides an additional $10,000,000 and continues to support FDA’s investments in International Mail Facilities and Ports of Entry to prevent illicit drugs, including unapproved and counterfeit pharmaceuticals, from entering the United States.”
Stopping opioids and counterfeit drugs is obviously something we can all get behind. It’s the word “unapproved” that poses a problem. To the FDA, an “unapproved” drug can include a medicine that is FDA-approved but not labeled in accordance with U.S. rules for the simple reason that it was packaged for sale in another country. For example, many drugs sold in Canadian pharmacies are considered “unapproved” if imported for personal use.
Let’s take a step back. The prescription opioid epidemic was initially caused by aggressive marketing by pharmaceutical companies, most notoriously (but by no means the only) Purdue Pharma, which led people to believe that the risk of addiction among patients prescribed oxycodone was very low. People who were treated for low-level pain were prescribed oxycodone and millions got hooked on it. Subsequently, all companies in the so-called legitimate supply chain — the big three wholesalers McKesson, AmerisourceBergen and Cardinal Health, and CVS and Walgreens, the largest national chain pharmacies — are paying billions to settle cases against them for their roles in opioid addiction, overdose and death.
Those same industries, often through funding of nonprofit organizations, have simultaneously lobbied for increasing enforcement against personal prescription drug imports — especially where orders are placed over the internet — and against federal and state legislation that would create new regulations to expand safe drug importation to help lower drug prices. One bill the industry favored was the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT Act, which became law in 2018. As the bill’s title indicates, its stated goal is to combat the opioid crisis. Yet the law is leading to the confiscation of non-opioid, medically necessary prescription drugs.
In fact, during the height of the pandemic, when Americans were trying to stay home, the FDA began stopping and taking greater numbers of non-opioid prescriptions at international mail facilities from patients who needed them. The agency’s own communications about the SUPPORT Act confirm the manner in which it intends to keep using it: The word “opioid” is only mentioned once on an FDA web page called, “Overview of the SUPPORT Act Provisions Related to Imports” and that’s in stating the law’s name. Otherwise, it simply focuses on stopping importation of all prescription drugs at international mail facilities.
In allocating new funding to improve the FDA’s capacity to stop opioid and other drug imports, Congress should also require the agency to provide an annual report breaking down by category the products they refuse and destroy. That reporting should clarify what percentage of such drugs were found to be opioids or counterfeits versus lower cost safe and affordable prescription medicines that patients had to go without.
Considering that the pharmaceutical industry caused both the opioid and the high drug prices crises, this is the least Congress could do. Even better, they should pass legislation to lower drug prices domestically, in which case far fewer Americans would seek to import in the first place.
Gabriel Levitt is president of PharmacyChecker.com and founder of Prescription Justice, a non-profit organization dedicated to lowering drug prices in America.