FDA Quality Metrics Proposal Sparks Objections, Disarray

25 Sep 2015

Pharmaceutical manufacturers argued FDA can’t make them report quality metrics data, but there was little else they could agree on in their initial reaction to the complex, enforceable reporting scheme FDA has proposed in its draft quality metrics guidance.

Industry’s anxieties about the pharmaceutical quality metrics guidance FDA drafted in July boiled over in an Aug. 24 meeting at FDA’s Silver Spring, Md., headquarters.

Groups for brand and generic drug makers, so often at odds in Washington, agreed on one point: FDA has no...