FDA Offers Details on Quality Metrics Collection

Details are starting to emerge on how the FDA’s quality metric collection program will be structured, with drugmakers likely being able to submit metrics data electronically to the agency using a downloadable form.

Drugmakers still don’t know the types of metrics or number they will have to collect, as the FDA hasn’t published draft guidance outlining the metrics program. The agency plans to use data collected from the metrics to make decisions about inspection frequency.

The FDA will likely require a standardized submission method, which could be a downloadable form, says CDER Director Janet Woodcock. “We will have to, in the draft guidance, talk about submission formats,” she acknowledges.

During a recent press conference on the new Office of Pharmaceutical Quality, Woodcock hinted that the records may be sent electronically, as the agency doesn’t “want pieces of paper with some numbers on them.”

OPQ will be responsible for collecting the data.

While electronic submissions will be the preferred method, the agency may also allow paper submissions, spokesman Stephen King says.

The FDA plans to issue the draft guidance on metrics this year, but specifics on what it will say are still largely under wraps. Agency officials have floated some potential metrics, such as batch failure rates, complaint rates, out-of-specification rates and metrics that measure CAPA and validation.

Once the guidance is finalized, drugmakers will have a two-year “safe harbor” period to set up their metrics collection. Metrics data collected during that time won’t count against a drugmaker’s quality record.

Woodcock reiterated that the FDA will not publish a company’s specific findings, nor require drugmakers to put score cards on product labeling.

The problem with score cards on labels, she notes, is that paper labeling remains on the market for a long time and drugmakers won’t be able to update the labeling quickly to reflect an improved quality status.

Woodcock, who is acting director of OPQ, has previously said the FDA will provide each company with its score and how they stack up to an industry quality average based on overall data. It will be up to individual drugmakers to decide to publish the scores.

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