A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported.
Six organizations — PhRMA, AAM, the International Society for Pharmaceutical Engineering, the Pharma & Biopharma Outsourcing Association, the Active Pharmaceutical Ingredients Committee and the Bulk Pharmaceutical Task Force — signed a joint letter saying the burden of the metrics collection outweighs the benefits and that more dialogue with the FDA is needed before any further guidance, rulemaking or other actions by the agency.
The groups also submitted comments individually, responding to the FDA’s revised draft guidance published November 2016, which adopted a phase-in approach to reporting, reduced the number of required primary metrics and supported both product and site reports.
Specifically, PhRMA asked FDA to clarify the impact quality metrics would have in inspectional risk management for sites participating during the voluntary phase of the program. The group also proposed, if the agency continues as proposed, to extend the first submission window for 2017 data from the month of January 2018 to the entire 2018 calendar year.