Counting Every Dose—How the FDA Tracks Drug Shortages (and What They Might Be Missing)
- September 19, 2025
- Meredith P. Vanderbilt , Bartko Pavia LLP
Drug shortages were not everyday dinner conversation before the COVID-19 pandemic, but scrambling for vaccines made all of us think about drug availability and who qualifies to be at the top of the priority list. In 2017, semaglutide (Ozempic™) was approved for the treatment of Type 2 diabetes. Millions of diabetics, including my mother, immediately reaped the benefits of Ozempic, including a lower A1C and significant weight loss. Beginning in late 2021, she started expressing frustration with pharmacies being unable to fill her prescription. She had to drive over an hour to another city to pick up one of her monthly doses. In March 2022, the American Society of Health-System Pharmacists (ASHP) and the Food and Drug Administration (FDA) first placed semaglutide on their drug shortage lists. The media largely attributed the shortage to off-label use for weight loss in non-diabetics. The GLP-1 drama that unfolded highlights several key questions about current tracking methods. How does the FDA track drug shortages? How does off-label use get factored into the calculations? Are cash purchases and compounded drugs included in these calculations? Are there unanalyzed data available to more adequately determine when a shortage starts and ends?
ARTICLE TAGS
You must be logged in to access this content.