FDA Clarifies Quality Metrics Won’t Spur 483s

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 company’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 it will get inspected more. 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 said during the FDA/PQRI Conference on Advancing Product Quality in Bethesda, Md.

Wesdyk said he also is 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.”

First NIPP Inspections Draw Praise

The FDA’s new proposed team-based inspection program completed its first round of pilot inspections and was deemed a huge success that helped investigators plan better inspections.

Investigators conducted 10 preapproval inspections and several surveillance inspections under the New Inspection Protocol Program, said Christine Moore, acting director of the Office of Process and Facilities. The results were used only for agency purposes and didn’t factor into regulatory decisionmaking, she said.

While roundly praised, the program won’t be rolled out officially for at least another year, after a second wave of pilots are completed in 2016.

Announced in April, the NIPP inspections will be risk- and rule-based, using expert questions, semi-quantitative scoring to allow for comparisons within and between sites and a common inspection report structure. Companies that exceed basic compliance will face less frequent inspections.

Companies that were inspected as part of the pilot were not informed in advance, Moore said, adding that the “alpha” pilot was solely for the FDA to see if inspectors could actually do it.

The NIPP is starting to take shape with a steering committee led by high-ranking FDA officials and three subgroups.

Three Groups Under CDER/ORA

The three subgroups are the Pre-Approval Inspection group, the Surveillance Inspection group and the tentatively named For-Cause Inspection group. Tentative scoring systems, investigator training, IT systems and investigator questions have been drafted for the first two groups, while the For-Cause group’s functions are being developed, Wesdyk said.

Wesdyk spoke during the FDA/Product Quality Research Institute Conference on Advancing Product Quality in Bethesda, Md.

The PAI and Surveillance groups have conducted pilot inspections, and more are planned, Wesdyk said. At this time, there are no plans for the for-cause group to conduct pilot inspections, as the pilots for the other two groups may be enough, he said. The pilot program is also testing a new IT system to support investigators while on site.

Once fully implemented, the PAI group will be tasked with conducting inspections whose observations inform premarket review decisions. The surveillance group will observe the state of quality in a facility to determine quality risk and perform routine inspections, Lawrence Yu, deputy director of the Office of Pharmaceutical Quality, said. The for-cause inspections will be handled by ORA and will look for evidence of cGMP violations to support enforcement actions.

Observations made in the PAI or surveillance inspections could trigger escalation or transition into for-cause inspections, Yu said.

The FDA released guidance in July in an effort toward improving compliance and inspection practices. Order our webinar FDA’s Draft Guidance – Request for Quality Metrics. Industry expert Andrew Harrison provides an overview of the guidance along with details on the specific quality metrics being requested.