Policymakers must address the growing counterfeit drug menace

Today, when we Americans swallow a pill from a bottle that was filled by our local pharmacy, we tend not to give it much thought. We trust that the pills are what the doctor ordered, will do what they’re intended, and will be safe. But it is not that way everywhere in the world, and there are no longer any guarantees even in the United States. 

The idea of compromised prescription medicines is difficult for many Americans to grasp. Because our drug system is so tightly regulated, there is no place where medicines are safer and more reliable.  As the U.S. Food and Drug Administration (FDA) continually refines and improves the way it reviews and certifies the safety of medicines, the end result is that the U.S. supply chain is the gold standard of drug safety. People living in certain other parts of the world don’t have it so good.  While data remains scarce, the World Health Organization estimates that upwards of 30 percent of the drug supply in some developing nations is counterfeit.  

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That’s because trade in counterfeit medicines is a global industry, with both small-time crooks and multinational crime rings preying on innocent (and in many cases uninformed) patients. In a supply chain that spans the world, a growing number of entry points have opened for ingenious criminals. This is particularly true in nations with less regulatory control, and presents a significant danger to U.S. patients with the rise of unlicensed, illegal rogue online pharmacies. Even in countries that are considered “safe”, like Canada or the United Kingdom, the FDA cannot guarantee that drugs purchased online from these countries were actually made there, as the FDA has no jurisdiction or authority abroad. 

The risk of even one counterfeit pill crossing the supply chain is profound when it comes to human impact.  In a best-case scenario, counterfeits will have ingredients replaced with cheaper, less effective ones. In worst-case instances, these “medicines” contain either no active ingredient or harmful and potentially lethal toxins. It’s also why it is so difficult to measure the magnitude of the problem: If a patient ingests what is supposed to be cancer medication but is nothing more than a sugar pill, it may not kill them but it is certainly not going to reduce their tumor.

The problem is so big, disperse, and complex that it requires a sweeping coordinated global response. And while experts agree that the U.S. drug supply is overwhelmingly safe, we are not immune. Last year’s report by the Government Accountability Office illustrated the growing threat of rogue online pharmacies and the health risks they pose to American patients. And according to the National Association of Boards of Pharmacy, 97 percent of all internet pharmacies do not meet the most basic criteria for accreditation. The reality is that all those emails clogging our inboxes from purported “Canadian” pharmacies are often selling unapproved, counterfeit and potentially lethal medicines with no guarantees of the drugs being produced in Canada or other so-called Tier One countries.

That’s why yesterday’s hearing on the problem of counterfeit drugs, convened by the House Energy & Commerce Committee, is so important. The Partnership for Safe Medicines, a leading advocate in this fight, hopes it will spark a new effort by our government to educate patients and begin taking stronger action to stop this growing public health menace. The Avastin incidents over the past two years, when counterfeit cancer medicine was sold to doctors and oncology clinics in the U.S., opened many eyes to these dangers and exposed counterfeits as far more than a mere nuisance.

The news isn’t all bad, however. Both the House and Senate worked towards the passage of the Drug Quality and Security Act last year, which will improve the safety of the drug supply chain. FDA has also played a leading role in helping stop counterfeits from infiltrating our borders and ensuring the prescription drug supply chain remains the safest in the world. Internationally, the U.S. has been participating in global sting operations coordinated by INTERPOL that have shut down thousands of illegal online pharmacies and seized millions of illicit or counterfeit medicines.

However, there much more to be done, and that requires decision-makers at all levels of our government to work in public/private partnership with industry, patients and providers. Our elected leaders must better understand the real nature of the threats posed by counterfeits and give FDA and federal law enforcement the tools and resources they need to keep our supply chain secure. With the rise of counterfeit medicines as a booming global industry, there is simply too much at stake for patient health to ignore the issue any longer.

LaGanga is the executive director of the Partnership for Safe Medicines and senior vice president, Public Affairs & Advocacy for PhRMA.

 

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