Drugs

Why Industry Resists FDA Quality Management Efforts

An online Clinical Leader guest column raises the question of why the drug industry is resisting quality management changes that FDA so clearly supports. PDC Pharma Strategy CEO Penelope Przekop, a quality management expert, says that at a recent meeting of agency representatives and stakeholders to discuss the challenges and successes of integrating quality by design and risk-based monitoring into the design and conduct of clinical studies, three industry barriers came up:

the drug industry does not understand the concepts and how to apply them, which perpetuates a low perception of value;
industry is not aligned in its understanding and definition of risk as applied to the quality management concepts; and
there is a pervasive overfocus on timelines and a deeply entrenched associated reward system.

The author lists 10 things that speakers and panelists at the session said the industry needs:

critical to quality processes, process steps, documentation and data must be properly identified;
thresholds for decisions and taking actions must be properly set;
those responsible for identifying criticality and thresholds must have the knowledge to do it correctly;
awareness and understanding of these concepts must be driven cross-functionally so that each function knows how it applies to their work and the value it brings not only in the long run but to their function;
quality by design can improve diversity in clinical trials, which is another advantage;
the healthcare industry needs to also understand how the concepts can improve the quality of natural history data;
that which is critical to quality must be specified in contractual agreements;
sponsors should be closely involved in the risk process;
the overfocus on how risk is scored is slowing progress and the industry must better understand the underlying point, which is to get cross-functional experts together as early as possible to brainstorm what can go wrong and make decisions;
100% source data verification is no longer expected and is inefficient; and
protocols need to be simplified.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome