A key component of our public health mission is to help ensure Americans have access to safe and effective medicines. That’s why, as drug shortages arise, we take immediate action within our authorities, working across the FDA and with other government agencies, industry, and other stakeholders, to minimize the impact of these shortages and maintain or restore availability of critical medicines for the patients who need them.
A shortage of even one critical drug can have a significant effect on U.S. patients‘ health. So many of our efforts are focused on preventing shortages in the first place. But when shortages arise, we must also focus on identifying the root cause, and on taking steps to help make sure similar circumstances don’t happen again. The lessons we learn help us inform and improve our efforts to prevent shortages in the future.
Ensuring that a necessary drug is available to a patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution of a medicine. This collaboration and coordination also applies when we work together to curtail a shortage.
Yet, despite our extensive efforts to prevent these shortages, they continue to occur and persist for a myriad of reasons. To more directly address these important public health challenges, the FDA developed a comprehensive three-pronged approach that focuses on preventing shortages, early identification of anticipated shortages, and responding by remedying the underlying problems when shortages arise to the extent possible within our current authorities. This approach will be discussed as part of a much larger conversation later this month, when we will host a public meeting to bring together stakeholders for an interactive, collaborative discussion to further inform our efforts and build on this work to identify strategies and solutions for minimizing harm from shortages.
The immediate need
External factors, such as potential bioterror attacks and natural disasters, are a sobering reminder of the vulnerability of our nation’s drug supply. It’s been just over a year since Hurricane Maria made landfall in Puerto Rico, halting production of critical fluids used for mixing injectable medications in hospitals and clinics. The hard work of many people throughout the drug supply chain was a vivid example of collaboration that’s needed among all stakeholders to avoid and mitigate the effects of drug shortages. In that case, this collaborative work has led to restoration of adequate supplies of these products.
However, drug shortages far more frequently result from failures within a complex manufacturing system strongly influenced by the marketplace and economic challenges that face certain segments of the pharmaceutical supply chain. Some critical drugs are reimbursed at very low levels, leading to the potential for underinvestment in manufacturing or manufacturers exiting the market. This, in turn, can increase the risk for supply disruptions and shortages.
We’ve talked a lot about drugs that some people believe may be priced too high. But it’s also true that there may be critical drugs that may sometimes be priced too low relative to the full cost of reliably producing a predictable and high-quality pharmaceutical product. These critical drugs are typically older generic medicines that must be in a sterile, injectable form. Persistent manufacturing challenges associated with more complex generics also can lead to shortages. In 2018, we’ve experienced some particularly severe shortages caused by these challenges. These include an ongoing and serious shortage of injectable opioids to treat patients in severe pain and a dangerously low supply of self-injectable epinephrine products that are used to reverse life-threatening allergic reactions. The self-injectable epinephrine supply issue has improved in recent months. But we’re still grappling with the public health challenges posed by the injectable opioids shortage.
In cases of severe shortages of critical medications, th...
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