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.
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.”
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