CANARX concentrates on delivering the safest possible prescription products to its plan members. They do this in a number of ways, including sourcing only from Tier 1 countries (countries with safety standards that equal or exceed those of the FDA and other agencies in the U.S.), by arranging for prescriptions to be filled only with brand-name products made by the FDA-approved manufacturer or its licensee, and by requiring pharmacies to dispense all medicine in manufacturers’ original, sealed packaging.
Interest in personal importation programs gained steam across numerous large-scale municipal, state and federal government bodies in 2019. As drug prices rose, political leaders in both major parties called for state and federal legislation that would provide for “CANARX-style” programs, often invoking CANARX by name. Because CANARX was the industry leader in helping Americans exercise their rights of personal importation, CANARX understandably received more scrutiny from both friends and foes of personal importation.
In February 2019, CANARX received a warning letter from the FDA that was highly publicized. The regulatory agency expressed a number of concerns relating to 14 specific medicines involving complicated or specialized administration that the FDA would prefer to see dispensed by local pharmacists who can hold frequent, direct, hands-on follow-up visits with the patients. CANARX reviewed the FDA’s letter, responded thoroughly to it, and, in an abundance of caution, decided to stop assisting patients in personally importing each of the 14 medications flagged by the FDA.
“We recognized their concerns and, though we have never had an issue with any of the medications in question, we agreed to remove them and show the FDA our willingness to work with them for the greater good,” said Bob Howard, President of CANARX. “It’s another example of an adjustment we made to our program based on concerns brought to our attention by a regulatory agency.”
CANARX has a long history in the industry, a history that includes many safety measures and formulary exclusions.
For example, CANARX long has refused to assist in the personal importation of medicines about which regulators have legitimate concerns in importation, such as controlled substances, targeted or precursor substances, and medicines requiring extreme temperature controls.
“Some may see a letter from the FDA as a bad thing – we do not. We believe the FDA’s attention provides an extra layer of regulation and safety for our clients. It’s our willingness to work with them that makes all the difference,” Howard said. “We at CANARX are eager to have and to comply with clear guidance from regulators. Some of our competitors – the same people who call attention to the fact that we received an FDA letter – flout the very cautions set forth in the FDA letter and routinely ignore numerous other FDA and safety standards.
We see it as an example of collaboration and validation of our ongoing efforts to ensure the safety of our program.
“Some competitors that crow that they have never received FDA correspondence do not disclose that they also work hard to mask their identities and hide from regulators,” he said. “CANARX, by contrast, is a very public program with a history that is well known to governments at all levels.”
Howard also points out that the fact that these competitors never received any FDA correspondence is in no way validation of their program, but rather confirmation that their programs lack the vetting that comes from these regulatory agencies, state and municipal governments.
“Our program has been recognized at the highest levels of government – we work with states and municipalities – and nobody else is in the same ballpark,” he said.
Approval in the U.S. is key to CANARX’s safety protocol. The drugs dispensed by pharmacies in the CANARX program are sent in their original packaging directly to the patient.
There is no way that CANARX would allow a dispensing pharmacy to ever send anything other than the brand-name medicine that the patient’s doctor has prescribed.
“We have a safety procedure in place for dispensing where if something’s short-dated at all, the pharmacists or techs would reach out to the patient to see how much they have on hand to confirm they’re OK,” Howard said. “Short-dated is anything less than six months from expiry. If there’s any conflict, the pharmacy just doesn’t send it.”
CANARX agrees with and supports the FDA’s ultimate goal of ensuring the safety of all U.S. residents by prohibiting unregulated and possibly dangerous medications.
The company believes it is part of the solution and leads the industry by example.
It’s spelled out in its safety protocol that includes regular visits to all dispensing pharmacies to ensure that all CANARX safety protocols and regulations are being followed. They must be fully licensed and up to date in every aspect of regulatory compliance. They must be insured. They must show that they can comply with exacting precision to the orders of the patient’s prescribing doctor. They must prove that their distribution chain will deliver to the patient only brand-name medicines, produced by FDA-approved manufacturers and their licensees, that come straight to the patient in the manufacturer’s original, sealed packaging. The goal of CANARX is to see to it that the patient receives precisely what the patient’s doctor ordered.
CANARX believes it offers the highest-quality, safest products on the market and its compliance with the FDA is proof of that commitment. Howard points out there is a great deal of pressure for change to control medication costs in the U.S. CANARX plans to keep helping Americans safely control their medical costs until all Americans have simple, safe access to affordable medications.