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# Concerns About FDA QMM Program
- URL: https://www.fdaweb.com/concerns-about-fda-qmm-program/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155882

The Association for Accessible Medicines (AAM) says that while it recognizes FDA’s significant efforts and investments to design a quality management maturity (QMM) program, it and its members have questions and concerns about the design and planned implementation of the program. In its comment [letter](https://www.regulations.gov/comment/FDA-2023-N-3721-0005?ref=fdaweb.com), AAM raises these issues:

- it remains unclear whether the agency’s planned QMM assessments will result in accurate, meaningful, objective, measurable, and helpful QMM evaluations or ratings;
- FDA should more clearly clarify and substantiate how it expects the program to reduce drug shortages;
- it remains unclear how FDA will be able to separate QMM assessments from its evaluation of current good manufacturing practice reliance;
- it remains unclear how QMM evaluations would not be affected by establishment size or age, or the types or number of products produced;
- it is unclear whether FDA has the requisite expertise and staff at this point to implement a QMM program at scale;
- QMM evaluation ratings and reports should remain private for the foreseeable future;
- FDA should rely primarily on third-party contractors to conduct on-site QMM evaluations;
- FDA should, for the foreseeable future, not use QMM evaluations in deciding which establishments to inspect; and
- FDA should clarify how it would protect trade secret and confidential commercial information acquired through the QMM process.

In its [comment](https://www.regulations.gov/comment/FDA-2023-N-3721-0006?ref=fdaweb.com), Lonza thanks FDA for soliciting comments and responds to the agency’s questions.