For Americans who order prescription drugs from licensed pharmacies in Canada and other countries, a little-known company called Zonos may play an outsized role in what happens after October 22.
Zonos is a U.S.-based cross-border commerce technology company that provides customs, tariff, product-classification, and import-compliance services. Its technology is integrated into international postal and shipping systems and is being used to help process packages under the new U.S. customs requirements taking effect this month. Zonos describes itself as a leader in cross-border technology whose systems support logistics providers, major brands, and thousands of e-commerce businesses.
Prescription Justice has been warning that the new Customs and Border Protection (CBP) requirements could severely disrupt personal prescription drug importation.
Beginning October 22, low-value international mail shipments containing products regulated by federal agencies will be electronically entered into CBP's Automated Commercial Environment (ACE). For prescription drugs, that means information about the shipment will be presented electronically to the Food and Drug Administration (FDA). Zonos itself explains the significance plainly: once postal parcels are entered into ACE, federal agencies such as FDA can see the information associated with regulated shipments.
That creates two separate questions for patients seeking to import prescription drugs for personal use.
First, will postal operators and customs service providers, such as Zonos, process personal prescription drug shipments and submit the required electronic customs entries? If these companies refuse to handle such shipments, the medications may never reach U.S. patients, regardless of whether FDA would otherwise allow them into the country.
Second, assuming the shipment can be entered, what will FDA do when it sees it? FDA has long exercised enforcement discretion over certain prescription drugs imported by individuals for their own use. But historically, only a small fraction of prescription packages moving through the international mail stream were actually presented to FDA for review. The new system could fundamentally change that.
Why Zonos became so important
Zonos's published guidance on personal prescription drug imports initially gave substantial reason for concern.
Its published guidance on prescription medicines describes FDA's Personal Importation Policy narrowly. Among other things, Zonos states that a prescription medicine generally must treat a serious condition for which effective treatment is not available in the United States. It also states that most foreign pharmacy websites designed to serve U.S. customers fail FDA's condition concerning commercialization or promotion to U.S. residents. Zonos stated even more directly that most personal prescription orders do not meet those conditions.
Against that backdrop, Prescription Justice had reason to be concerned that Zonos might decline to facilitate the typical personal prescription drug shipment when the medication was already commercially available in the United States. If that became the operational rule, it could effectively shut down much of the existing Canadian pharmacy market for U.S. patients — regardless of whether FDA might otherwise choose to exercise enforcement discretion and allow a particular shipment.
That is why Prescription Justice has been focused on the "Zonos factor."
Then came the Zonos webinar
On October 6, Zonos held a webinar addressing the new postal requirements. The discussion provided important new information about how Zonos expects the process to work and, according to Zonos, guidance it has recently received concerning FDA's handling of these shipments.
The webinar did not eliminate the uncertainty surrounding personal importation after October 22. But it provided a considerably more nuanced picture than Zonos's published materials alone might suggest.
Here are the key takeaways.
Zonos indicated that it can serve as the importer of record for these shipments. During the webinar, when the question arose as to who would serve as importer of record, Zonos indicated that it would perform that role.
Zonos indicated that products sold in both countries can move through the postal stream and be presented to FDA. FDA can then decide whether to allow or refuse the shipment. The presenters expressly acknowledged that patients sometimes obtain these medications internationally because they are cheaper.
That is potentially significant.
Zonos also said patients will not be required to attest that the medication is unavailable in the United States. That removes what could otherwise have been an obvious barrier for Americans importing the same brand-name medications that are sold domestically at much higher prices.
The pharmacy and patient will instead need to provide information supporting the personal-use nature of the shipment. Zonos discussed obtaining a patient attestation when the order is placed, as well as information concerning the prescription and prescribing physician.
Zonos appears to be building a system designed to collect the necessary information before the package reaches the border. Zonos emphasized that obtaining complete information in advance should make FDA review more efficient and reduce the likelihood of packages being held while additional information is obtained.
That approach is consistent with Zonos's broader description of its new system. Its public materials explain that its technology identifies products requiring information for federal agencies and asks shippers for missing data — including, where applicable, FDA product and intended-use codes.
The focus may now shift squarely to FDA
Perhaps the most important implication of the webinar is that Zonos may not be the categorical barrier to personal importation that patients and advocates feared.
If Zonos is willing to facilitate these shipments, serve as importer of record, collect the required information, and electronically present prescription drug shipments to FDA even when the medication is commercially available in the United States, then the central question becomes what FDA does with them.
And Zonos repeatedly emphasized that FDA retains discretion.
According to the webinar, Zonos has recently been told that FDA will exercise enforcement discretion. The presenters also acknowledged that FDA's personal-importation determinations remain case-by-case and that concepts such as whether a product presents an "unreasonable risk" ultimately depend on FDA.
When specifically asked about Americans continuing to obtain lower-cost prescription drugs from Canadian pharmacies, including drugs available in both countries, the presenters went further: they acknowledged that FDA can still exercise enforcement discretion and even encouraged people concerned about access to affordable medicines to contact their elected representatives.
That does not mean patients are out of the woods.
Beginning October 22, FDA will have visibility into international mail shipments that historically often moved through the postal system without an FDA admissibility determination. Zonos itself says that this is the fundamental change: regulated postal shipments will now be entered electronically so that agencies such as FDA can review the information.
But the October 6 webinar suggests an important distinction.
The new system does not necessarily have to stop personal prescription drug importation at the front door. Zonos appears prepared to facilitate the entry and present the shipment and supporting information to FDA. What happens next may depend principally on how FDA chooses to exercise its enforcement discretion.
For patients who depend on safe, lower-cost medicines from Canada and other countries, that makes FDA policy — and the Administration's decisions about how that discretion should be exercised — more important than ever.
[If you have or create a Zonos account, you watch a video of the webinar here: https://zonos.com/webinars/shipping-pharmaceuticals-us-postal-americas-emea.].