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# Why Industry Resists FDA Quality Management Efforts
- URL: https://www.fdaweb.com/why-industry-resists-fda-quality-management-efforts/
- Published: 2024-02-20T12:00:00.000Z
- Updated: 2026-09-14T14:23:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156395

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](https://www.clinicalleader.com/doc/the-fda-speaks-up-for-quality-management-must-they-beg-0001?ref=fdaweb.com) 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.