FDA proposes to rate pharmaceutical manufacturing facilities
The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM) as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper. The ratings would be publicly available.“QMM ratings are a part of an evolution towards performance-based regulatory practice and, as such, they may raise concern for some,” according to the white paper. “Public transparency is often a necessary driver for industry improvements. Pharmaceutical executives, for example, may not like the fact that a poor QMM rating could affect their stock price. However, public knowledge of facility issues and product recalls already has severe negative consequences to stock price.”
QMM assessments and ratings would be considered surveillance functions and “separate from determining compliance with regulatory standards,” according to FDA.
FDA first discussed plans for a rating system in 2019 to incentivize the pharmaceutical industry to improve the quality of products, and to reduce drug shortages. (RELATED: FDA Floats Idea of a Rating System for Drug Manufacturers, Regulatory Focus, 25 October 2019).
An agency report in October 2019 found that up to 60% of drug shortages are caused by quality issues. (RELATED: Drug Quality: FDA Officials Discuss Perception, Regulatory Focus, 3 February 2020).
The white paper characterizes QMM as the “state attained by having robust, reliable, and robust business processes to achieve quality objectives and promote continual improvement.”
Such a rating system “could inform purchasers about the level of QMM at sites from which they purchase drugs. In the absence of the transparency generated by ratings of QMM, there is risk that price competition and cost minimization will continue to be key market drivers, especially for generic drugs, without direct reward for manufacturers who actively invest to avoid future shortage.”
The paper does not present any specific proposals for the rating system but rather outlines a broad policy framework. FDA said implementing a QMM rating program would require collaboration with industry and other stakeholders. The agency has already formed multidisciplinary, multi-center working groups to develop a program.
For such a rating system to work, the market would need to reward products from facilities with higher QMM scores, FDA said. “The use of QMM ratings in purchasing decisions should incentivize continual improvement in the long term, but not push manufacturers out of the market and/or markedly raise purchasing costs in the short term.”
Yet one of the challenges of a rating system is convincing purchasers to use it in making decisions. “The current perception among stakeholders who do not already use some type of supply chain rating in purchasing decisions is that quality of all kinds exists fundamentally if the drug has been approved by FDA. Some do not consider quality management maturity in their decisions.”
The agency will be holding two workshops on quality management maturity, on May 24 and May 25. The first workshop will address CDER’s QMM program and the second will discuss quality ratings.
The paper also follows up on two pilots to measure QMM at a pharmaceutical and active pharmaceutical ingredient (API) site (RELATED: CDER launches quality management maturity pilots for APIs and finished dosage forms Regulatory Focus, 16 October 2020).
The program would also complement FDA’s quality metric proposal released in early March (RELATED: Quality metrics: FDA wants feedback on pared-down program, Regulatory Focus, 8 March 2022).
White paper
