STAT+: Pharmalittle: We’re reading about FDA reporting side effects, pharma plants near disaster zones, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation. Our choice today is maple cinnamon French toast, which occupies a prominent spot in our cupboard. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …

The U.S. Food and Drug Administration announced it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis, STAT writes. Previously, the database of the reports, called the FDA Adverse Event Reporting System, was updated quarterly. There was no mention of changes related to databases of adverse event reports for other products, including vaccines, medical devices, food, and dietary supplements.  The database has limitations. Its adverse events reports can be duplicated or incomplete, do not prove causation, and have not been vetted or medically confirmed. Also, it does not contain “narrative” information explaining exactly what happened to patients. That information can be obtained only through a Freedom of Information Act request. Still, the database gives researchers an overview of potential safety concerns. 

Most pharmaceutical manufacturing facilities in the U.S. are situated in regions prone to hurricanes, wildfires, and other natural disasters, placing the supply chain in significant jeopardy, Regulatory Focus notes, citing new research in JAMA. The authors identified 10,861 active drug production facilities from 2019 to 2024 and found nearly 63%, or 6,819, were in counties when a disaster was declared. On average, almost 34%, or 2,146 active facilities, were impacted by a disaster declaration. The authors used the FDA Drug Establishments Current Registration Site database to identify the location of all facilities that manufactured drugs that were distributed in the U.S. during that six-year period and cross-referenced them with Federal Emergency Management disaster declarations in the same time. Climate-related disasters in counties included fires, hurricanes, storms, tornadoes, and floods.

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