In November 2016, FDA published a revision of their draft guidance in which the number of metrics was reduced from four primary metrics and three optional metrics to three primary metric areas (lot acceptance rate, invalidated out-of-specification rate, product quality complaint rate) (we reported).
Meanwhile, a second round of comments from various industry groups has been sent to FDA, again voicing concerns.
The Cross-Industry Quality Metrics Collaboration Group (1) writes “After careful deliberation and analysis, the Collaboration Group believes that FDA’s metrics collection proposal should be paused and there needs to be further public dialogue between industry and the Agency before FDA’s metrics collection efforts proceed further by guidance, rule-making, metrics collection notice or other means. The full burden and benefit for industry, FDA and patients must be considered and defined to achieve a positive benefit-burden balance” and in addition “We believe that the burden of FDA metrics collection far outweighs the benefits, at least as currently proposed.”
IPEC-Americas also prepared and submitted detailed comments to docket FDA-2015-D-2537 in March 2017. Their comments focused on the applicability of current proposed metrics to excipients manufacturing operations and the many challenges that they would present to excipient manufacturers.
IPEC-Americas stated that “The metrics that the Agency has suggested in the voluntary phase of the program would be difficult to apply to excipients or atypical actives because manufacturing processes are different for excipients than for drug product and APIs.” In addition, the drug product manufacturer already has provisions in-place to ensure that the excipients they use in their drug products comply with product quality and specification requirements. IPEC-Americas takes the position that“... since the draft Guidance still has many unanswered questions for the finished drug product manufacturer, it is IPEC-Americas position that the Guidance should be devoted to pharmaceutical drug products and not expanded to include excipients and atypical actives.”
All in all it can be said that industry believes that FDA is substantially underestimating the burden the program would impose, especially when it comes to costs, resources, operational challenges, management attention that is drawn away from more important tasks for patient health and safety. Now, it remains to be seen how the FDA will deal with the subject and if the agency is willing to seek the dialogue with the pharmaceutical industry.