FDA Reassures Industry on Use of Quality Metrics

The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions.

The quality metrics effort is not an enforcement program; it is a surveillance program, explained Russell Wesdyk, acting director of the Office of Pharmaceutical Quality’s Office of Surveillance. Submission of metrics will be used to determine a firm’s risk score in the selection model used to prioritize scheduling of routine surveillance inspections, he said.

To encourage data submission, sites with more metrics could see a greater reduction of score, Wesdyk, said, adding “more information is better than less information.”

For example, a drugmaker may worry that high recall or batch failure rates will mean they’ll get inspected more. In fact, it could be just the opposite, as the numbers could be in line with other like manufacturers, Wesdyk said.

In fact, a manufacturer that submits fewer data or data showing a very low recall or failure rate could draw more agency scrutiny, he added. He spoke at a session last week at the FDA/PQRI Conference on Advancing Product Quality in Bethesda, Md.

Wesdyk said he is also surprised by the amount of feedback from industry groups questioning the agency’s authority to collect quality metrics. He said the FDA is trying to help industry and is not the “boogeyman hiding behind trees.”  

Meanwhile, ISPE said it is nearly halfway through the data submission and collection phase of its quality metrics pilot program, which is continuing despite differences in its metrics and those the FDA has targeted. Three of the four quality metrics the FDA plans to collect — lot acceptance rate, product quality complaint rate and invalidated out-of-specification rate — are accounted for in the eight quality metrics ISPE is collecting.

ISPE has collected data from 21 companies covering 88 sites so far. Data collected by Oct. 30 will be analyzed for inclusion in ISPE’s comments on the FDA’s draft guidance on quality metrics, which are due Nov. 27, said Máiréad Goetz, co-chair of ISPE’s quality metrics team.

The final deadline for collecting data under ISPE’s pilot program is Nov. 30. The totality of data will be analyzed for ISPE’s final report, expected next February or March, Goetz said. — Kellen Owings