Industry Questions FDA Authority to Enforce Quality Metrics Guidance

August 28, 2015

Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during a public meeting last week on the draft document.

To ask for quality data, the FDA would need to add the quality metrics to current good manufacturing practices, PhRMA told agency officials. GPhA echoed that concern, saying there’s no statutory authority to require manufacturers to generate new records. The generics trade group also wondered whether the FDA’s authority would extend outside the U.S.

GPhA also had grave concerns with the agency’s stance that failure to supply metrics would be equivalent to refusing an inspection, which could cause products to be deemed adulterated.

Seven industry groups spoke at the Request for Quality Metrics public meeting at the FDA. The groups’ comments were precursors to formal comments they will submit in response to the FDA’s June 28 draft guidance on quality metrics. They asked the FDA to extend the Sept. 28 comment period deadline.

Quality Metrics Requirements

Stakeholders also urged the agency to require fewer metrics initially and to focus on collecting data at the site level, rather than the product level.

The guidance identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers would collect for each product they produce. Any firm involved in the manufacture, preparation, propagation, compounding or processing of a finished dosage product or API would have to submit quality metrics data, which would be used to decide how often firms are inspected.

Both ISPE and GPhA urged the agency to collect quality data at the site level, as it is more representative of how industry collects and reports data. It would also reduce the burden of starting up the program, as companies would be tasked with sorting through and presenting data in ways they typically do not, ISPE said.

GPhA also asked the FDA to request metrics directly from contractors instead of making it the application holder’s responsibility to gather the metrics from them.

On implementing the program, ISPE recommended a phased introduction, with Diane Hagerty saying the FDA should “start small, learn and evolve.”  Hagerty, who is vice president of global technical operations for quality systems and processes at Roche, suggested starting with higher-risk facilities or products that are medically necessary with no alternatives. She also suggested an initial voluntary reporting stage with finished dosage facilities and deferring API reporting to a later phase.

ISPE also wants the FDA to use a smaller starting set of three metrics and reiterated its position that the annual product review on time rate metric should not be included. Not only did ISPE not see any correlations or outcomes from that metric in the first phase of its pilot program, but the group is concerned about unintended consequences, such as firms focusing on timeliness of the review over quality or thoroughness, Hagerty said.

The FDA is also underestimating how long it will take companies to collect the data, ISPE said, noting drugmakers that participated in the pilot program had to adjust their IT systems and incorporate additional review and data retention methods.

GPhA asked for a safe-harbor period to allow companies to prepare accurate, meaningful metrics. The group also suggested the process is being “unduly rushed,” considering the significance of the initiative.

Russell Wesdyk, acting director of the CDER’s Office of Surveillance, said the final guidance will come out in 2016.

Full implementation of the quality metrics program is “several years away,” Christine Moore, acting director of the Office of Product Quality’s Office of Process and Facilities, told attendees at the recent GMP by the Sea Conference in Cambridge, Md. — Kellen Owings