Your health could be put in unnecessary danger soon. There is an idea gaining traction to import potentially dangerous drugs into the United States. This would jeopardize the most crucial element of trust in our health system. You trust the credentials and experience of your doctor. You trust the advice and treatment your doctor prescribes. You trust that the medications you take are safe and effective. That trust means everything to patients facing health issues both big and small.
Amazingly, Food and Drug Administration Commissioner Scott Gottlieb has been tasked with the responsibility of “developing focused drug importation policy options” through a newly formed working group. In the announcement, Health and Human Services Secretary Alex Azar said he was “open to all potential solutions” assuming they are “effective, safe for patients and respect choice, innovation, and access.” The task of this working group should be rather simple, as drug imports have been shown to fail by every one of these measures and are destined to do so again.
Start with safety and effectiveness. Four former FDA commissioners, who served under both President Bush and President Obama, sent a letter to Congress denouncing risky proposals to open our market to potentially contaminated drugs from foreign countries. They argued that undermining our carefully designed system of safety checks and quality assurances would harm both patients and consumers alike.
Through their tenures, they saw firsthand how the global marketplace is saturated with counterfeit and substandard medications. They ominously noted that the “vast majority of internet sites that advertise as being Canadian are actually based in South America, Eastern Europe and Russia.” These kinds of concerns were recently on full display, when the FDA halted the importation of drug ingredients by Chinese company Zhejiang Huahai Pharmaceuticals, after a recall of one of its drugs that contained a probable carcinogen. Couple that with well documented importation horror stories, such as when fake cancer drugs entered the United States or when smuggled Canadian drugs were misbranded, and you begin to see a pattern of failures cannot be ignored.
On cost and access, the policy of foreign drug importation comes up short as well. When the Congressional Budget Office examined drug importation, it found at most a “modest reduction” in prescription drug spending and a “negligible reduction” if imports are narrowed to Canada alone. When Gottlieb himself examined this issue in 2004, he agreed with the Congressional Budget Office findings and said that scheme would have “added so much cost to the imported drugs” and would not be be much cheaper “than drugs sold inside our closed American system.”
All risk with no reward does not sound like great policy. What has always distinguished the United States been its unquestionable global leadership in research and development. Our companies are on the frontlines of discovering groundbreaking treatments. They continue to push science and technology to the benefit of patients around the globe. Any broad importation plan would inevitably hurt patent protection, thereby undermining the motivation to innovate. After all, the total cost of bringing a new drug to market these days is $2.6 billion dollars.
These concerns ultimately bring us back to the concept of trust. If patients cannot trust and rely on the safety of their treatments, the cost benefit of importing these risky medications, or the hope of innovative medical discoveries, then what good is importation as policy anyway? As the working group explores this issue, it must recognize the flaws of importation for what they are, a dangerous gambit built on the health of patients. Otherwise, we will all be in for a sick awakening.
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