US FDA’s ‘Mature’ Approach To Quality: ‘Encourage More, Punish Less’

10 Jun 2022

• By Michael McCaughan

Proposed ‘Quality Management Maturity’ rating system would be a way to be more ‘proactive and rewarding’ rather than ‘punitive’ when it comes to oversight of pharmaceutical manufacturing. The initiative is clearly important to the head of FDA’s drug quality office.

Carrot and stick — The US FDA hopes to emphasize carrots instead of sticks in its QMM initiative. • Source: Shutterstock

The US Food & Drug Administration is hoping to build support for its Quality Management Maturity initiative with the message that the goal is to encourage and reward high-quality firms, rather than rely on existing mechanisms to “punish” non-compliance.

In closing remarks after a two-day workshop on the QMM initiative hosted by FDA May 24-25, Office of Pharmaceutical...