A (not) new Rx: Quality Improvement for NAM.

Area of Science:

• Toxicology and Safety Assessment
• Regulatory Science
• Public Health

Background:

• New Approach Methodologies (NAMs) are increasingly used in food, drug, consumer product, and chemical safety assessments.
• Despite technological and legislative growth, widespread adoption of NAMs faces significant challenges.
• A sense of frustration accompanies the rapid development and publication of NAMs.

Purpose of the Study:

• To assert that challenges in NAMs adoption are not unique.
• To identify opportunities for learning from the Quality Improvement (QI) movement.
• To offer recommendations for NAMs development and implementation.

Main Methods:

• This commentary analyzes the challenges of NAMs adoption.
• It draws parallels between NAMs adoption hurdles and experiences within the Quality Improvement (QI) movement in public health and healthcare.
• Lessons learned from QI are applied to inform NAMs strategies.

Main Results:

• The challenges encountered in NAMs adoption share similarities with those historically faced by the QI movement.
• Decades of QI experience offer valuable insights, both positive and negative, applicable to NAMs.
• Specific strategies can be derived from QI to facilitate NAMs integration.

Conclusions:

• The perceived uniqueness of NAMs adoption challenges may be overstated.
• Leveraging the extensive experience of the QI movement can accelerate the successful integration of NAMs.
• Targeted recommendations based on QI principles can guide future NAMs development and policy.