FDA GMP Quality Metrics Will Be Industry’s ‘SAT Score’
This article was originally published in The Pink Sheet Daily
Executive Summary
Number 2 pencils will not be required, but FDA hopes the reports will make purchasing decisions resemble the college admissions process to some extent.
FDA hopes that its pending system for collecting standardized metrics about product manufacturing will allow purchasers to do some comparison shopping based on quality.
Once the system is up and running, the agency hopes that the GMP metric will act a little like an college entrance exam, FDA’s Russell Wesdyk told the Generic Pharmaceutical Association’s Fall Technical Conference Oct. 29.
“We will make public – just like you do with an SAT score – the ranges of scores that were achieved,” Wesdyk, who serves as scientific coordinator in the Office of Planning and Informatics, said.
“A company would know their individual score, a company would know their decile ranking within the various ranges, but their next door neighbor would not know that. A buying group could of course ask a company for its score and its decile, and it’s up the company whether to release. … That hopefully provides a reasonable balance for all involved.”
Wesdyk noted, “It’s likely some of the data collected will be considered company confidential and might be inappropriate for us to make public. At the same time, there is a shared interested on the part of some buying groups – and many in industry quite frankly – for members of industry to leverage it to do a good job on the quality front.”
FDA has been trying to encourage purchasers to place a premium on quality in order to achieve a range of policy goals – from preventing drug shortages to thwarting rouge compounders (Also see "Compounding: Hamburg Asks Purchasers, States To Push Outsourcer Registration" - Pink Sheet, 10 Jan, 2014.).
But Wesdyk acknowledged that so far at least, extracurriculars – such as being able to offer a really low price – have been swaying the admissions committees of even the most prestigious purchasers.
“It would benefit all of us – all of us that are manufacturing high-quality products – if purchasing decisions were actually influenced to some extent by the quality of the drug product. I don’t know if we can ever get there, but I do know that is was an interest both of industry and of other stakeholders to see if it was possible,” he said.
Good Score Lets Firm Place Out Of Requirements
FDA is hoping to release its proposed metrics in a draft guidance by the end of the year, but that goal may be ambitious given that the agency has yet to even decide whether it might actually issue the plan as proposed reg or another document such as working paper.
Wesdyk hopes that whatever comes out can be commented on and finalized within a year, which would be an exceptionally fast pace for FDA policy development.
The quick timeline underscores the importance that quality metrics program has as part of FDA’s transition to a risk-based inspection approach (Also see "FDA’s Plaisier: GMP Oversight Must Shift To Outcomes Model" - Pink Sheet, 4 Aug, 2014.).
Wesdyk said the shift in the agency’s operational approach could have operational benefits for industry as well.
“We’d like to be able to identify and reward firms for going above and beyond requirements, firms that are doing an outstanding job. … If you’ve got a low-risk product coming out of a low risk site, we don’t have to inspect so frequently and we don’t need to receive supplements. We can downgrade post approval change requirements into annual reports,” he said.
Unfortunately for industry, however, Kaplan is unlikely to start a GMP consulting business to help them cram for the test.