Unfortunately, this risk is far from imaginary, particularly within the urology space. Sildenafil citrate (Viagra) and other erectile dysfunction drugs are believed to be among the world’s most counterfeited, as more men are turning to the Internet to obtain these pills. While it is hard to accurately measure just how many counterfeit ED drugs are available and how many actually make their way into the U.S., the numerous counterfeit examples on record paint a rather grim picture.
Just a few months ago, two men were sent to federal prison after being convicted of introducing adulterated and misbranded prescription drugs into the U.S. commerce system. Each admitted to trafficking more than 10,000 counterfeit sildenafil and tadalafil (Cialis) pills, importing them from China and selling them to individuals for further distribution to unsuspecting customers. The counterfeit drugs contained less than or none of the active ingredients listed on the label, even though they looked authentic.
Many proponents believe that drugs imported from reputable countries with relatively high regulatory standards, such as Canada, are safe, but this belief is dangerously misguided. Countries with relatively safe markets still do not impose the same level of protection afforded under the U.S. regulatory system, but even if they did, there is no guarantee that drugs imported from those countries actually meet those standards. Most foreign governments impose a lesser standard of regulation on products intended for export and do not regulate the transshipment of products through their territory.
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Thus, these countries generally lack the ability to ensure that drugs exported to the U.S. are safe. In fact, the Canadian health agency, Health Canada, has expressly stated that while it regulates medications manufactured for its citizens, it is not responsible for the safety and quality of drugs imported into the U.S.
But even if foreign governments could guarantee the safety and quality of the drugs they export, importation would create an opening in our currently closed distribution system that would allow adulterated and counterfeit drugs to penetrate the U.S. market. This is not an insignificant problem by any means: the number of counterfeit drugs both globally and in the U.S. has continued to rise over the past decade, due in large part to the proliferation of online pharmacies. Men who try to buy ED drugs online will almost certainly receive a drug that contains, at best, a lower dose of the active ingredient—and at worst, none at all—mixed in with other unknown materials that can range from brick dust to paint to potentially poisonous chemicals.
Simply put, the proposed importation plan would allow the already booming counterfeit drug market to flow into the U.S. with virtually no way to adequately monitor and police it. And given that ample evidence suggests that importation itself would likely have a minimal effect on drug costs and patient access to affordable medications, importation is a shortsighted approach to a complex problem that at best promises temporary, minimal cost reductions at the expense of patient safety.
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