Are non-U.S. drugs unsafe?

Late last month, as part of its Internet Drug Outlet Identification Program, the National Association of Boards of Pharmacy (NABP) released a new report that claims that 96 percent of the online pharmacies they reviewed are out of compliance with established U.S. laws and standards. All of these websites are identified on a “Not Recommended List” that makes no distinction between licensed and unlicensed pharmacies. Since this list is very misleading, we at RxRights had to comment and give our readers some context.

For starters, it is significant to note that the NABP’s Not Recommended List was launched with a grant from Pfizer. Pfizer has a vested interest in preventing prescription drug importation. The company, both directly and through the Pharmaceutical Researchers and Manufacturers of America (PhRMA), has spent many millions of dollars on lobbying the White House and congress to block drug importation legislation, and on media scare campaigns designed to dissuade Americans from personally importing cheaper medications.
With the Not Recommended List, the NABP has created a false dichotomy when it comes to prescription drug safety. The NABP would have us believe that all U.S. prescription drugs are safe while all foreign drugs are not.

According to the NABP report, 3,310 of the 7,541 pharmacies reviewed “offer foreign or non-Food and Drug Administration (FDA)-approved drugs.” But does “foreign” or “non-FDA approved” translate directly to unsafe?

Roger Bate of the American Enterprise Institute is an expert in the area of counterfeit drugs. He published a study last August that tested drugs purchased from online pharmacies against FDA approved drugs. Drugs tested from licensed foreign pharmacies passed the test. Among Bate’s conclusions: “…there are many website pharmacies, including those from overseas, from which it is almost certainly safe to procure medicines…” 

The FDA is tasked with ensuring the safety of America’s prescription drugs. But “FDA-approved” is by no means the only measure of drug safety. Many other countries also have excellent systems for regulating pharmaceuticals, and some are arguably safer than our own, as some contend is this case with Canada. 

Canadian and other international pharmacies often sell the exact same drugs as we get at home with the only difference being packaging. Lipitor bought in Canada, for example, is still made by Pfizer, but its label is printed in both English and French, and of course it’s much less expensive. In this case, the fact that the Canadian Lipitor is “not FDA-approved” clearly has no bearing on its safety.

Claiming that drug safety is compromised just because a drug is imported is absurd since much of our “FDA-approved” drugs are actually imported. In fact, 40 percent of pharmaceuticals sold in U.S. pharmacies are imported.  And even more surprising, given all the claims that foreign drugs are unsafe, is the fact that about 80 percent of “FDA-approved” drugs are made with active ingredients produced in foreign countries, mostly China and India.

The truth is that drug safety can never be absolutely guaranteed, by any regulatory agency. Just look back on last year’s GlaxoSmithKline fraud case, in which that company knowingly sold substandard (but “FDA-approved”) medication, or the many Johnson & Johnson recalls of children’s medication.

We are not saying that there aren’t many rogue online pharmacies. Americans need to be careful when shopping for their medications online. But the NABP is not serving the cause of public health and safety by misleading Americans about online pharmacies. It ought to remove from the “Not Recommended List” any online pharmacy, whether domestic or foreign, that meets proper standards of mail-order pharmacy safety.

Read the NABP’s report: “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: April 2011

In light of this report, we at RxRights wanted to remind our readers that the FDA does not prosecute individuals for personal drug importation. We’d also like to reiterate some best practices for choosing safe and affordable online pharmacies from which to order your prescription drugs.

We remind you that legitimate online pharmacies:

1.    are licensed;
2.    guarantee patient privacy and confidentiality;
3.    require a prescription from the patient’s doctor; and
4.    have a physical address and phone number, and will answer questions over the phone.