This editorial by Peter Pitts was published in The Hill on January 23, 2019. Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
Proposed drug importation bill would expose Americans to counterfeit meds
Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) just introduced legislation to legalize the importation of prescription drugs. The "Safe and Affordable Drugs from Canada Act of 2019" would enable Americans to purchase cheap medicines from Canadian pharmacies for their own personal use. The lawmakers believe the bill would reduce patients' spending at the pharmacy counter.
Lowering drug costs is a noble goal, but importation is not the answer. At best, the bill would yield little savings. At worst, it could endanger American lives by opening the floodgates to harmful counterfeit drugs.
Drug importation is hardly a novel idea. Politicians have floated various importation schemes for decades.
Several U.S. states and cities have even set up importation programs, which mostly imploded shortly after their inception. For instance, Boston's mayor set up a program in 2004 to give city employees access to imported Canadian drugs. But only a few dozen people ever signed up for the program, which was closed down in 2008.
There's a good reason such programs weren't successful. For starters, Canadian drugs aren't as cheap as they're chalked up to be.
Importation advocates have long exaggerated the disparity between Canadian and American drug prices. They often point to a handful of specialty drugs that cost more in America. In reality, most generic medicines cost the same or less in the United States than they do in Canada.
And generics account for roughly 80 percent of prescriptions filled in the United States. One study from the nonpartisan Congressional Budget Office estimated that legalizing prescription drug importation would only reduce U.S. pharmaceutical spending by 1 percent.
The safety risks of importation far outweigh any meager savings.
The FDA can't regulate Canadian pharmacies, so there's no way to verify whether the drugs purportedly imported from the Great White North are safe. During a weeklong anti-counterfeiting operation last year, Canadian officials inspected nearly 3,600 packages — and found that 87 percent contained counterfeit or unlicensed health products.
A striking number of "Canadian" drugs aren't actually from Canada. Canadian internet pharmacies regularly import drugs from less developed and less regulated countries, like Turkey. Then they slap on their own labels and ship them elsewhere.
One FDA operation found 85 percent of "Canadian" drugs originated in 27 different countries. And more than a third of those drugs were potentially counterfeit.
Such concerns explain why Illinois ditched its importation program, I-SaveRX, in 2009 after failing to adequately inspect foreign pharmacies. According to a state audit, "40 percent of the required inspections of the foreign entities claiming to be pharmacies were never completed, putting patients at risk" and patients were left with "no regulator to protect them."
Canadian regulators have warned Americans that importation could be risky. One official at Health Canada, which oversees that nation's pharmaceutical supply, said the regulator "does not assure that products being sold to U.S. citizens are safe, effective and of high quality and does not intend to do so in the future."
Senior U.S. officials have issued similar warnings. Over the past 18 years, in both Democrat and Republican administrations, every FDA commissioner and secretary of Health and Human Services has failed to certify that importation is safe.
If Sens. Grassley and Klobuchar's bill passes, more counterfeit drugs could find their way into the United States. Congress should think twice before putting the health of American patients in jeopardy.