Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance

On Thanksgiving Eve, FDA issued the revised Quality Metrics Guidance. Is the revised document something for industry to be thankful for? Let’s break it down:

  • Allowance for a phased-in, voluntary approach – This is something that many industry groups have been asking for, since the burden, as well as the complexity of collecting metrics from large, multi-product, and multi-site companies may be very high; this allows companies to put systems and processes in place in advance of mandatory reporting. Additionally, FDA indicated that they would not take enforcement action based on errors in quality metrics data submission in the voluntary phase, as long as the submission is made in good faith. So as companies are figuring out how to do it, there won’t be any penalties if there are glitches in the system. FDA believes that the platform for voluntary reporting will be available in 2017.
  • Reduction in the number of elements to collect, specifically eliminating the Annual Product Review on time metric – According to the FR Notice, this was done to reduce the reporting burden, although this was probably the easiest of the metrics to report, with the clearest definition. The Guidance also eliminates the optional metrics related to CAPA effectiveness.
  • Support for both product and site reports – The Guidance will permit submission of data by site segmented by product, or by product segmented by site. The aggregation of data by site or product was also a significant point of contention between FDA and industry, and this should allow companies to submit data in a way that is best for them.
  • Modifications to Quality Metrics data definitions – Appendix B of the revised Guidance contains the new definitions and illustrative examples. The examples are informative, and will help companies with their internal definitions.
  • Addition of comment fields- This has been a constant request from industry. The new Guidance allows for up to 300 characters to explain data. The Guidance gives the following examples when an explanation might be warranted – “natural disasters, the use of emerging technology, or describe the manufacturing supply chain or a plan for improvement.”  The ability to provide a narrative note will give companies the opportunity to explain some data that they feel is not reflective of their overall quality.
  • Clarifications of special considerations for non-application and OTC reporting.
  • Quality Metrics Reporters List – FDA intends to report a list of the names of establishments that voluntarily report all or a subset of quality data as described in this Guidance (i.e., product reporting establishments and site reporting establishments). Reporting establishments will be broken down into Product and Site Report categories, and then tiers within those categories.

It seems that FDA listened to at least some of the industry concerns. There are still some larger issues that have been left unanswered, like the legal basis for collecting this data, but, overall, this new Guidance seems to be a reasonable compromise.

Lachman is helping many companies with metrics implementation. Now that this looks like it is closer to implementation, feel free to contact us, if you have any questions or needs.