Industry groups express misgivings on FDA’s QMM program

Several elements of the US Food and Drug Administration’s (FDA) proposal to implement its proposed quality management maturity (QMM) program faced pushback from major pharmaceutical trade groups, including the Association for Accessible Medicines (AAM) and the International Society for Pharmaceutical Engineering (ISPE).

The groups said there were no clear regulatory incentives to participate, and raised questions related to how the program would alleviate drug shortages. A plan to assign a score or rating system to companies also drew resounding opposition.

There were also calls for the agency to align its QMM program more with the Center for Devices and Radiological Health’s (CDRH) Voluntary Improvement Program for devices. (RELATED: FDA seeks feedback on quality management maturity program, Regulatory Focus 18 September 2023)

The goals of the program are to create a “strong quality culture mindset,” to recognize those firms that have advanced QMM practices, target areas where QMM practices can be improved, and minimize risks to product availability. Trained assessors would conduct the QMM assessments, either onsite or in a hybrid environment, over the course of two to five business days.

FDA also sought input on other matters, including what advantages manufacturers anticipate from participating in the voluntary QMM program, the benefits of participating, whether there are any unintended consequences or roadblocks from participating, and industry’s thoughts about making the outcome of a QMM assessments public and whether quantitative ratings should be assigned to sites after an inspection.

While the QMM program has “value to FDA, industry, and patients, regardless of industry-led or regulator-led,” ISPE said it “has concerns about proposals for an FDA-initiated QMM program. Without concrete regulatory incentives, manufacturers may shy away from a regulator-led program, reducing the program’s reach and effectiveness. Furthermore, public sharing of QMM ratings could be misinterpreted and lead to undesired consequences, which could also deter manufacturers from joining a voluntary QMM program.”

AAM: Unclear how program will alleviate drug shortages

AAM said it was not clear how the QMM program would help reduce drug shortages. The group cited a study by the IQVIA Institute, which links shortages to “unsustainable pricing practices” and not QMM practices.

“FDA has justified the QMM program in part on a finding that most of drugs that went into shortage between 2013 and 2017 were linked to manufacturing or product quality issues. At the same time, however, FDA has stated that QMM does not assess product quality nor CGMP compliance. Addressing such questions about the underlying justifications for the QMM program will likely help further clarify the intended purpose, function, and scope of the program.”

IPSE, BPTF and Moderna oppose rating system

ISPE, the Bulk Pharmaceuticals Task Force (BPTF) and drugmaker Moderna also opposed a QMM rating system.

ISPE wrote that while not FDA’s intention, a QMM rating “could potentially be misinterpreted as a rating of product quality, which could lead to misinformation, promote patient aversion, fear, lead to medication/pharmaceutical product compliance issues, decrease public confidence in manufacturers, and result in unmerited bias against specific manufacturing regions or sectors (e.g., OTC, generics). Additionally, sharing the rating/output with the public may lead to misinterpretation leading to poor conclusions and decisions.”

BPTF similarly asserted that “all manufacturers are different. Does the scoring of QMM program reflect the complexity of manufacturing? For example, one company may have a single product, a mineral-based orally dosed API in a dedicated unit, alongside its other chemical non-pharmaceutical operations. Another company may make multiple pharmaceutical products, small molecules and biologics, potentially sterile and parentally dosed, in non-dedicated equipment. Organizations that are large and complex will be structured accordingly, and they will have far more resources to hire people and to fully implement a robust QMM program. This creates the potential to push small businesses out of the market.”

BPTF said the group “firmly asserts that semiquantitative scoring systems using a ‘Gold Star,’ or the like, bests resolve potentially subjective nature of the scoring. Lastly, there are concerns surrounding the ability of FDA to support the program, with regards to budget and resources.”

Moderna also questioned the value of a rating system. “There appears to be a significant potential for misinterpretation among stakeholders regarding the FDA’s QMM ratings. Despite clear communications from the FDA indicating that the QMM rating system pertains to product availability reliability rather than overall product quality, experiences from the seminar held in May 2022 and the November Advisory Committee suggest ongoing confusion. There is a risk that end-users, patient groups, media, and the general public might misinterpret these ratings as indicators of product quality, leading to unwarranted concerns or hasty interpretations.”

ISPE wants alignment with CDRH’s Voluntary Improvement Program

In other areas, ISPE recommended the proposed QMM program align more closely with FDA’s CDRH’s Voluntary Improvement Program (VIP) which is primarily facilitated by industry.

ISPE states that “the VIP program offers participating manufacturing sites potential benefits including enhanced risk-based inspection decisions, reduced review timelines, and/or reduced submission content for changes.”

The idea for a QMM program first emerged in 2019 when an interagency task force called for the development of a new system to measure and rate the QMM of drug manufacturing facilities to address the root cause and potential solutions for drug shortages. (RELATED: FDA Task Force Recommends Rating System for Drug Manufacturing Quality, Regulatory Focus 29 October 2019)

FDA further refined the plans in proposals in a plan released in 2022. (RELATED: FDA proposes to rate pharmaceutical manufacturing facilities, Regulatory Focus 7 April 2022)

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Industry groups express misgivings on FDA’s QMM program

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