FDA to Grade Industry on a Curve – Are You Ready?

By: Daniel R. Matlis

Do you remember having tests graded on a curve?curve

FDA is gearing up to grade industry on a curve.

The FDA Safety and Innovation Act (FDASIA) grants the Agency a number new authorities that will change the way FDA interacts with Industry.  For details, read: FDA Rolling Out e-Inspections

FDA held a public meeting on the implementation of these authorities.

During the meeting, Susan de Mars, FDA Senior advisor with the Office of Regulatory Operations and Policy described how FDASIA “… allows us to request records that we can get during an inspection in advance of or in lieu of a physical inspection.”

“This means that we can replace an expensive on-site inspection with this kind of records review. We can also use this authority to collect information and then based on that target where we need to do the on-site inspections” added de Mars.

Under these new authorities, the Agency plans to request that manufacturers periodically provide standardized quality metrics already in use such as:

  • Batch Failure Rates
  • Right First Time
  • Out Of Specification

FDA plans to utilize business intelligence and analytics tools to compile and aggregate these data to develop an industry wide risk model. This model would be used to drive inspections as well as trigger compliance or enforcement actions following an inspection

The resulting analysis would also provide a company “grade” or at least a point on a curve.
According to Howard R. Sklamberg, Director of CDER’s Office of Compliance, FDA does not currently plan to issue company report cards. However, he explained that FDA would direct resources to those companies who are on the lower end of the curve (the cutoff point has not been determined).

“We don‘t have the capacity to all the time to be in every firm,” commented Mr. Sklamberg. “But we want to encourage those firms to prioritize quality and encourage their boardrooms and their pocketbooks because quality cost money,” he added

“We want to target our limited inspection resources to the firms that we think are ones that pose the greatest quality risk” said Sklamberg.

Is your company ready to be graded on a curve?

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