FDA Policy/General

FDA Planning for Future Public Health Issues

FDA commissioner Robert Califf and chief medical officer Hilary Marston say the agency is learning from experiences during the Covid-19 public health emergency to better prepare for future public health emergencies, supply chain disruptions, geopolitical changes, and natural disasters. Writing in an FDA Voices online post, Califf and Marston review agency activities during Covid-19 and report that since Covid-19 highlighted vulnerabilities in medical product supply chains, FDA has established new or more comprehensive programs to help address the issue. FDA will be positioned to tackle future public health emergencies, they say, by:

monitoring the availability of medical products by integrating data from a wide variety of mandatory and voluntary reporting sources;
predicting supply chain vulnerabilities and risks by integrating internal and external data sets for analysis using artificial intelligence, including natural language processing and machine learning; and
preventing or mitigating shortages with strategies such as shelf-life extensions, expedited review of manufacturing supplements and generic drug applications, exercising temporary enforcement discretion for new sources of medically necessary drugs, and requesting that manufacturers establish risk management plans to mitigate the potential for shortages, as appropriate.

Califf and Marston also write that FDA is initiating a new inspection planning system that will be more efficient, transparent, and adaptable to changing needs.

“There have been lessons learned about how FDA’s authorities could be modernized in the reauthorization of the Pandemic and All-Hazards Preparedness Act to ensure our actions could be even more effective,” the two conclude. “Providing greater transparency into supply chains to improve resiliency and prevent and mitigate shortages of medical products and the food supply, ensuring operational readiness and surge capacity within the FDA inspectorate and review staff, and improving laboratory testing regulation are priorities that will enhance national security and improve public health preparedness.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome