FDA Task Force Recommends Rating System for Drug Manufacturing Quality

Regulatory NewsRegulatory News | 29 October 2019 |  By 

The US Food and Drug Administration (FDA) on Tuesday published a new report on the root causes and potential solutions for drug shortages, recommending a new system to measure and rate the quality management maturity of individual drug manufacturing facilities based on objective indicators.

The recommendation to create such a rating system is one of three recommendations made by FDA’s inter-agency Drug Shortage Task Force in its 124-page report, which also recommends creating a shared understanding of the impact of drug shortages and the contracting practices that contribute to them and promoting sustainable private sector contracts.

The need for such a rating system, as discussed in an FDA blog post last week, comes as the task force says the market “does not recognize and reward mature quality management systems” and as it “does not compensate drug manufacturers with price premiums for mature quality management.”

As many manufacturing sites have focused their efforts on compliance with current good manufacturing practices, which FDA says set “a minimum threshold,” companies do not have a need to pursue “more advanced levels of quality management, which aim to robustly detect vulnerabilities and address them in order to prevent the occurrence of problems, nor do they establish a culture that rewards process and system improvements,” which is important as drugs in shortage are typically older drugs, with a median time since first approval of almost 35 years.

For generic drugs especially, the task force notes that the market often does not provide incentives for manufacturers to invest in updated manufacturing technologies and improvements in quality management. And even when manufacturing facilities invest in such technologies and improvements, the report notes that it can be difficult to “identify measures of quality that could be used to predict operating outcomes, such as shutdowns of manufacturing lines resulting in supply disruptions.”

As no rating systems currently exist, the report explains that such a system would need to provide clear, concise and objective information about the maturity status of a manufacturing site’s quality management. Industry groups and drugmakers previously raised questions with FDA’s plans for a mandatory quality metrics program.

And although FDA says separately that it’s “working on implementation of a reporting program so that certain key metrics are reported to the agency,” an FDA quality metrics pilot program ended in July and the agency has yet to finalize a revised draft guidance from 2016 on submitting quality metrics data.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, noted on a call with reporters that the rating system would likely be voluntary and not linked to the agency's push for quality metrics. She noted that this report will hopefully serve as a conversation starter.

And the agency maintains that by creating a rating system, buyers will recognize and reward manufacturing quality maturity. 

“This could be done through a number of different mechanisms, such as paying higher prices for drugs manufactured at top-rated facilities, requiring a certain quality maturity rating as a condition of contracting, or guaranteeing purchase of a set volume of products from sites achieving a certain maturity rating,” the report adds.

As far as root causes for drug shortages, the report also points to three: Lack of incentives to produce less profitable drugs, not rewarding manufacturers for mature quality management systems and logistical or regulatory challenges that make it difficult for the market to recover after a disruption.

Report | Drug Shortages: Root Causes and Potential Solutions


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