The prognosis for this diagnosis is not promising: “We expect that reports of potential and actual drug shortages will continue to increase in the next months to years,” says the FDA, “requiring that the FDA allocate more resources to mitigate drug shortages in a timely manner to protect public health. In doing so, we will continue to focus on assuring a multifaceted approach, including close collaboration of all stakeholders within and outside of the agency, including industry, regulators, payers, Congress and others.”

 

This is not a uniquely American problem, by the way, as reports continue to arise that doctors and patients in Canada and Australia are also battling this crisis.

 

While the problem is indeed multifaceted, and the solutions thus varied and complex, shouldn’t addressing drug shortages a top priority for an industry that claims—on every press release that crosses my desk and in most of the stories we write—that its very reason for existence is “to address a high unmet medical need?” Is there any higher unmet need right now for patients? What must happen in order for pharmas and biotechs to hunker down and resolve this crisis?  

 

Don’t we owe Mihaela—and the millions of other patients in her situation—more?