Drug importation: Shortsighted and ineffective

Based on a partnership with Urology Times, articles from the American Association of Clinical Urologists (AACU) provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or info@aacuweb.org for more information.

After storming onto the scene following a few highly publicized controversies, the cost of prescription drugs continues to be at the forefront of the health care debate in America, and for good reason. List prices for drugs in the U.S. are on the rise, and, as the health care system gets more complex and convoluted, even those with insurance are being forced to pay more out of pocket for their prescriptions. It is therefore hardly surprising that according to a recent poll, 77% of Americans believe the cost of prescription drugs is unreasonable, and 74% think Americans pay higher prices for their drugs than people in Canada, Mexico, and Western Europe.

In the face of mounting pressure to take definitive action to keep the costs of prescriptions down, an increasing number of legislators are addressing drug costs in a variety of ways.

One method that is gaining traction in Washington is drug importation. Sen. Bernie Sanders (I-VT) recently introduced a bill to permit drugs to be imported first from Canada and then from other developed countries after 2 years. The proposed legislation has become somewhat popular among Democrats in Congress. On its surface, it appears to be an appealing idea: drugs are cheaper abroad due to price controls and other mechanisms, and bringing in those cheaper drugs gives Americans lower cost alternatives to U.S.-manufactured medications. But as alluring as it may seem at first glance, drug importation in reality is as dangerous as it is ineffective.

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The closed distribution system for prescription drugs in America allows the FDA to monitor virtually every aspect of the supply chain, all the way from manufacturing to distribution, in order to ensure that patients receive safe, effective, and quality medications. This closed system is critical to protecting patients from unsafe, substandard, adulterated, and counterfeit medications and has made the U.S. drug market the most trusted and secure in the world. The importation plan established under the proposed legislation would undermine the fundamental integrity of this closed system, compromising the many safety protections it affords.

To its credit, the bill does attempt to address these safety concerns by requiring all foreign exporters to be certified and by prohibiting importation of drugs not manufactured at FDA-inspected facilities. But despite claims that importation under this plan would be adequately monitored to assure drug quality and safety, these provisions are simply insufficient to prevent adulterated, contaminated, or counterfeit drugs from infiltrating the U.S. supply chain and could put patients at risk for potentially serious harm.

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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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