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# AAM Issues with FDA Quality Metrics Program
- URL: https://www.fdaweb.com/aam-issues-with-fda-quality-metrics-program/
- Published: 2022-06-08T12:00:00.000Z
- Updated: 2026-09-14T17:47:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152011

The Association for Accessible Medicines (AAM) says FDA’s proposed potential new direction for a quality metrics reporting program may not align with five principles the association described in a 3/10/21 white paper submitted to FDA. In a 6/3 comment [letter](https://www.regulations.gov/comment/FDA-2022-N-0075-0009?ref=fdaweb.com), AAM says it’s concerned that the agency’s proposed direction “may still lack appropriate statutory authority, may incorporate metrics that have not been validated and that may not be relevant to quality, and would incentivize the submission of metrics that are not meaningful and that would not advance public health.”

In its response to an agency request for comments on the metrics proposal, Vizient [says](https://www.regulations.gov/comment/FDA-2022-N-0075-0011?ref=fdaweb.com) it uses quality metrics as a factor in strategic sourcing decisions. “To enhance quality metrics,” it says, “information on each measure, per facility, per product, would be most needed. Vizient provides various suggestions for the agency’s consideration as it further develops the quality metrics reporting program.”

Finally, AstraZeneca [responded](https://www.regulations.gov/comment/FDA-2022-N-0075-0007?ref=fdaweb.com) to questions posed by FDA in its request for comment.