In Recall Index, Beth Weinman Discusses FDA Efforts to Incentivize Enhanced Quality System Maturity to Reduce Drug Shortages

The U.S. is understood to be the world’s largest producer of medicines. Yet drug shortages persist and the Food and Drug Administration has recognized that many drug shortages are largely due to manufacturing quality issues. The issue of ensuring a steady supply of high quality drugs may be the drug safety challenge of our generation.

In a Recall Index article authored by life sciences regulatory & compliance counsel Beth Weinman, 112 pharmaceutical recalls and 40 drug-related warning letters the agency issued in the first quarter of 2024 are analyzed in the context of drug shortage risks posed by immature quality management  and FDA efforts to develop a ratings system to reflect quality management maturity, or “QMM.”

Beth notes that if a ratings system is ultimately implemented, highly ranked drug manufacturers are likely to see fewer inspections and may be able to market their high QMM scores to consumers and payors. Similarly, drug manufacturers assigned low QMM ratings may ultimately find themselves to be higher inspection priorities in a risk-based inspection surveillance environment, and more likely targets for FDA enforcement action if quality practices are found to be lacking.

Beth explains that the goal of FDA’s QMM program is to incentivize manufacturing firms to invest in their quality systems with the hope that, ultimately, doing so will improve drug quality and reduce shortages.