FDA report on drug shortages recommends rating system for manufacturers

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Makidotvn)
(Image: Getty/Makidotvn)

Related tags: Fda, Food and drug administration, Drug shortages

FDA urges manufacturers to ‘sell quality’ to fight drug shortages, releasing a report on the potential introduction of a rating system to reward transparency and investments in quality management.

Led by the US Food and Drug Administration (FDA), the Drug Shortage Task Force came up last week with a report​ examining the root causes and potential solutions for drug shortages in the US. 

More specifically, the report identified three main causes of drug shortages:

  • Lack of incentives for manufacturers to produce less profitable drugs
  • The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues
  • Logistical and regulatory challenges make it difficult for the market to recover from a disruption

As per the potential solutions, the task force highlighted the need to create a 'shared understanding' of the impact of drug shortages on patients, as well as to promote sustainable private sector contracts, in order to ensure a reliable supply of drug products.

Moreover, the FDA-led team suggested the introduction of a rating system, which would aim to incentivize drug manufacturers to invest in quality management maturity of their facilities.

Rating would be used to inform purchasers, group purchasing organizations (GPOs) for health care systems, and consumers about the quality management maturity of the manufacturing facilities. 

“This effort would introduce transparency into the market, and provide companies committed to quality management maturity with a competitive advantage, potentially enabling them to obtain sustainable prices as well as grow market share,”​ commented Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement​ titled “To help reduce drug shortages, we need manufacturers to sell quality ​– not just medicine.”

The regulatory agency’s executive noted that the analysis of recent drug shortages indicates the need for rewarding investment in improved quality management services by manufacturers, and cited the results of a research conducted by FDA economists, regarding drug shortages.

According to the research, concerns found in manufacturing processes or product quality caused supply disruptions in 62% of the drug shortage cases that occured between 2013 and 2017.

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