Quality metrics for pharma manufacturing is back in a big way, with FDA pledging to 'objectively rate' firms
After the FDA signaled an interest last month in returning to its hotly-contested quality metrics program for pharma manufacturers, the agency this week outlined what it wants to do while pledging a public workshop in May and an adcomm later this year.
While the nitty gritty on these metrics may be more than a year from fleshing out, a new white paper outlines the FDA’s tentative plans, explaining how transparent “Quality Management Maturity” ratings could empower manufacturers to identify ways to improve the effectiveness of their quality systems.
“There must be clear incentives for industry to achieve higher QMM,” FDA said.
But CDER also acknowledges that these QMM assessments and ratings need to be part of the center’s surveillance functions, and separate from determining compliance with regulatory standards.
“The scope and implication of a QMM assessment must be distinct from one determining CGMP compliance (i.e., looking for behaviors and indicators above meeting minimum regulatory requirements). Between on-site QMM assessments, information such as quality metrics could be more routinely submitted to FDA to bolster and support ongoing confidence in the QMM rating of the site,” FDA said.
Stakeholders at a 2020 Duke-Margolis workshop “largely agreed,” according to the FDA, that the need to develop and implement quality ratings is driven by the desire to differentiate products for purchasers by an attribute other than price.
“QMM ratings based on manufacturing sites are of limited value if purchasers do not have insight into the specific facilities manufacturing the drugs or components they intend to purchase, especially as related to API manufacturing,” FDA said. “It will be necessary for purchasers to have supply chain information to use QMM site ratings in drug purchasing decisions.”
But the FDA also recognizes the many concerns coming from all corners.
The pharma industry previously questioned the value and utility of the metrics data, and the increased burden of collecting and submitting it, while FDA said health care professionals indicated concerns about liability and risk associated with using QMM ratings in decision-making related to patient care, particularly if there were “issues stemming from providing a drug from a lower-rated facility.”
While noting that one of its end goals for the FDA is for “top-rated manufacturers in the US, both large and small,” to gain “a competitive advantage, potentially enabling them to grow market share and increase their workforce,” the agency also acknowledged the unintended risk that purchasers may use QMM ratings to buy drugs from lower-rated sites for lower prices to realize short-term cost savings.
Developing QMM ratings based on manufacturing site rather than product also removes health care professionals one step from a decision-making process informed by QMM, as most health professionals have “little or no supply chain site insight, especially as compared to purchasers,” FDA said.
The agency’s focus on quality metrics began almost a decade ago, with the agency seeking ideas from stakeholders as to be more proactive around drug shortages, the majority of which are caused by manufacturing issues or quality problems.
“It became clear that those in the industry with an early warning system for availability risks use quality metrics,” the FDA said. “As a result, the FDA recognized a ‘blind spot’ in regulatory business processes (e.g., inspections, product quality defect reports): nearly all were reactive, focused on detecting negative outcomes.”
A few years later, the FDA offered up and then heavily revised a draft guidance (following industry critiques) on how to submit metrics data, including quality-related complaints. Eventually, the guidance spawned two FDA pilot projects in 2018 with pharmaceutical manufacturers to inform the criteria used to objectively measure a manufacturing site’s QMM, but neither amounted to much more until recently.
“Feedback from the participants in the pilot programs is now helping determine best practices for conducting the assessments, the assessment tool, and associated logistics,” the FDA said.
“The fact that they’re [FDA] continuing to look at this is promising,” Michael Ganio, senior director at the American Society of Health-System Pharmacists, previously told Endpoints News. “And we know they recognize the importance of quality in drugs in the supply chain … it makes sense to give some sort of incentive or measurement so purchasers have more information on whether they’re rewarding more reliable product manufacturers.”