FDA Quality Metrics Program Delayed, Extended to Biologics

The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers.

The agency this fall announced it planned to select metrics by the end of the year, and start collecting data on them by fall of 2015. But now officials say they have no timeline on implementation.

In another wrinkle, agency officials said they will give manufacturers a two-year grace period to comply with the reporting requirements as opposed to the one-year period it initially planned. Once the metrics are finalized, data collected during the grace period could be used for positive actions, such as fewer inspections for a high-quality facility, but won’t drive enforcement decisions.

Including biologics manufacturers poses several hurdles. While CDER will apply the quality metrics programs to all manufacturers, CBER director of compliance Mary Malarkey said the center will apply the metrics program selectively, and it is now deciding which categories of products will be involved.

Once the CBER selection process is complete, CDER and CBER plan to create a standard set of 8 to 10 metrics that they will require manufacturers to submit to the agency, Russell Wesdyk, head of the quality metrics program told the Parenteral Drug Association’s Quality Metrics conference recently.

“We don’t want two sets of metrics for different organizations,” he said.

Wesdyk added that the FDA is still considering collecting nine metrics already disclosed by agency officials, such as batch failure rate, right-first-time rate, number of corrective and preventive actions conducted and number of annual product review reports conducted on time. These metrics will be used by the FDA to decide which facilities to inspect.

He said that the initial metrics will be published as either a draft guidance or proposed rule, and emphasized that industry will have an opportunity to comment on the metrics.

The FDA has said it will hold a public meeting early next year to get feedback on the metrics, and plans to publish final guidance by September 2015. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.