For years, BIO has been urging both state and federal policymakers to adopt responsible solutions that would make prescription drugs more affordable for America’s patients. At times, our advocacy work includes the need to raise concerns with some of the policy proposals being discussed. That’s the case when it comes to the false promise of importing prescription drugs from foreign countries as a way to save money.
Some public officials are promising voters that a way to lower the cost of medicines is the “safe importation” of prescription drugs, often through the creation of publicly-run importation programs for certain groups of patients or employees. Elected leaders in Maine, Vermont, Florida and other states have joined the chorus. But as we learned again last week, there is really no such thing as safe drug importation, whether done by individuals or ostensibly through more formal public or private sector programs. Any promise to the contrary is an empty—and dangerous—one.
The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a pharmacy middleman that ships medicines from foreign countries to patients in the United States. The FDA’s enforcement action highlights both the significant patient safety dangers and considerable operational problems associated with drug importation. As the New York Times reports:
“The Food and Drug Administration on Thursday said a major Canadian drug distributor was selling unapproved and mislabeled medicines to unsuspecting Americans looking to save money on prescriptions, and warned it to stop. The company, CanaRx, sells many common prescription medicines at a lower cost to hundreds of public and private employer programs in the United States. …
“The warning letter requested that CanaRx immediately stop selling unapproved new drugs from foreign sources to American buyers. It noted that CanaRx’s disclaimer told consumers that their medicine may have appeared to be different in size, shape or color than what the consumer had bought in the United States.
“‘Having this disclaimer in each invoice demonstrates that CanaRx has designed its business to operate in a manner that substitutes the F.D.A.-approved drugs prescribed by the U.S. health care provider with unapproved drugs,’ the F.D.A. wrote.”
Other details about the FDA’s enforcement action against CanaRx are also disturbing:
- Certain products offered by CanaRx are “subject to one or more recalls in the U.S.” and that “no such safeguards exist” to weed out potentially recalled products. This means American patients lack any “protection or recourse should they receive or be harmed by drugs” brought in the U.S. outside of FDA’s enforcement jurisdiction.
- The online entity also provides drugs that “have different trade names and/or dosage amounts in their labeling than their FDA-approved counterparts,” which threatens to create confusion for patients, lead to medication errors, and make it hard for physicians to respond to possible side effects.
- CanaRx also offers products that are subject to FDA-required Risk Evaluation and Mitigation Strategies (REMS) that must be prescribed, administered, and monitored in specific ways to prevent significant patient safety concerns. FDA notes that “CanaRx is causing important safety measures that are put in place for the FDA-approved versions of these drugs to be bypassed.”
CanaRx boasts on its website that it’s an “international prescription service provider” to public sector programs throughout America. It’s first program was launched in New York, and it has allegedly expanded to over 560 community, school board, county, and private sector programs.
There’s little doubt that some of these programs were offered to patients, families, and employees under the guise of “safe” drug importation. But the warning letter sent to CanaRx highlights why it’s impossible to reconcile drug importation with the FDA’s critical role of ensuring the efficacy and safety of all medicines prescribed to America’s patients.
Drug importation poses obvious and very serious risks to patients, as experts have warned and the FDA’s recent enforcement action makes clear. All policymakers—state and federal—should abandon this dangerous scheme and instead work on safe, responsible solutions to make prescription drugs more affordable. In the meantime, all patients should heed the advice—and warning—of Dr. Scott Gottlieb, the FDA’s current commissioner:
“We urge employers and any enrolled employees not to use any medicines from CanaRx. The FDA will pursue additional enforcement actions as needed.”