Inspections Help Prevent Drug Shortages: Study
A new study is contradicting previous assumptions about the relationship between regulatory scrutiny and drug shortages in the U.S. pharmaceutical supply chain. Researchers from the University of Illinois’ Gies College of Business have found that GMP deficiencies cited in FDA inspections are associated with fewer future drug shortages, not more. The findings, published in the journal Manufacturing & Service Operations Management, challenge a 2016 Government Accountability Office (GAO) report (see story), which suggested that citations following FDA inspections contributed to drug supply disruptions.
“For years, the belief was that when the FDA cited manufacturing facilities for quality issues, it would lead to lower production and more shortages,” said study co-author and professor at Gies Business Gopesh Anand. “Our more rigorous statistical approach showed the opposite.” The research team used inspection data obtained through a Freedom of Information Act request, along with drug shortage data from the University of Utah Drug Information Service. Their analysis spanned two decades of FDA inspections and applied advanced instrumental variable modeling to isolate the impact of inspection outcomes.
Contrary to GAO’s conclusion, the study found that facilities receiving an “official action indicated” — FDA’s most severe inspections rating — were 96.4% less likely to experience a drug shortage in the ensuing 12 months, while those with the less severe “voluntary action indicated” VAI rating were 77.2% less likely. “The intuitive fear was that focusing on compliance would divert resources and reduce supply,” the study authors say. “But what’s actually happening is that these inspections trigger improvements in manufacturing consistency and quality, ultimately reducing the risk of shortages.”
The agency began tracking drug shortages under the 2012 FDA Safety and Innovation Act. In recent years, concerns about the fragility of pharmaceutical supply chains have grown, especially during global events like the Covid-19 pandemic. The authors also emphasized that the new findings should reassure FDA inspectors that their ratings help rather than harm supply resilience.
They have begun informal conversations with FDA about the implications of their findings. While the study stops short of making formal policy recommendations, it strongly suggests that increased transparency and enforcement during inspections can play a positive role in securing the U.S. drug supply.