Last week, in a warning letter and press release, the FDA went to great lengths to demonize what appears to be an exceedingly safe personal prescription drug importation program offered by a Canadian company called CanaRx Services, Inc. I believe the agency crossed the line with bad advice to patients. In a nutshell, about 500 U.S. cities, companies, and other organizations use CanaRx to offer their employees and retirees a lower-cost international pharmacy option. The prescription medicines are mailed from licensed pharmacies in Canada, Australia and the United Kingdom to U.S. consumers. CanaRx’s programs have been in effect for almost 20 years and helped taxpayers and patients save $250 million, according to the company.
So, what’s the problem?
First off, obviously, Big Pharma wants this…
I’m going to leave this explanation to Phil Galewitz at Kaiser Health News:
Fortunately, like the title indicates, these programs will continue.
But I want to make one point: The FDA did not cite any evidence in the letter of any bad medicines discovered at all. Yes, it stated that violative drugs were sold through the CanaRx program. The agency generally deems drugs violative because they are not labeled for sale in U.S. pharmacies (i.e. they are “misbranded”) and/or they were manufactured in a plant that is not registered with the FDA (i.e. they are “unapproved”). Thus, almost every drug sold from a pharmacy Canada, Australia and the UK imported into the U.S. will fall under the FDA’s definition of violative. That word doesn’t change the fact that they are safe and effective medicines.
As much as it annoys me, the FDA is within the bounds of its mandate to refer to lawfully-manufactured, safe and effective medicines as misbranded and/or unapproved.
But can the FDA refer to such drugs as “unsafe”?
Well, in the FDA’s press release they did just that. The FDA headline [Extra, Extra, Read All About It] on CanaRx reads:
Not only did the FDA make that “unsafe” claim but went on to state:
“To protect patients from these unapproved drugs, we urge employers and any enrolled employees not to use any medicines from CanaRx. The FDA will pursue additional enforcement actions as needed.”
Wow! The FDA just recommended that patients not take their medication. Unless the FDA knows, because they have investigated it, that people received counterfeit (falsified) or adulterated medicines, isn’t it dangerous to give this advice? What if people stop taking their blood pressure, heart, asthma, or diabetes medicine because of this medical advice?
Down the page of the press release, common sense seemed to prevail:
“Consumers who have concerns about any medicine they are taking supplied through CanaRx should talk with their health care provider before stopping or making other changes in their treatment.”
Which is it Dr. Gottlieb? Forget about the companies involved. That ambiguity is misguided and not fair to patients.CanaRx, Enforcement, Scott Gottlieb