Drug Industry Has Concerns With Quality Metrics Guidance

Branded and generic pharmaceutical industry groups have concerns with the FDA’s draft guidance on quality metrics, especially in the area of data reporting.

In recent comments, the industry groups said the Food and Drug Administration has underestimated the significant costs and burdens for manufacturers in collecting and reporting quality metrics data. They said the agency should phase in these requirements. They also said the FDA should use a rulemaking process, rather than a draft guidance, to implement the quality metrics program.

Also, a biotechnology industry group said the FDA should more clearly state the intended use of the collected metrics ...