The firestorm over baby formula shortages offers an opportunity for the Food and Drug Administration to address a bigger and more fundamental issue: the potential for similar circumstances across the agency’s entire regulatory portfolio.
More than a decade ago, the FDA was in the midst of addressing a similarly intense tempest over drug shortages, with clarion calls to fix the problem from Congress, the media, health care providers, and the broader regulatory ecosystem. In 2010, 77% of drugs in short supply were sterile injectable products, critical in the acute care setting. Media coverage highlighted the plight of patients and physicians faced with shortages for cancer drugs, anesthetic agents, and critical care medications. Drug back orders caused patients to receive substitute therapies that added expense to patient care. Not surprisingly, the reasons for these shortages were almost identical to the current baby formula imbroglio: manufacturing issues.