Pause Sought in Quality Metrics Guidance
Pharmaceutical Research and Manufacturers of America (PhRMA) says that its members believe that additional dialog between FDA and industry is needed to resolve several fundamental issues before an agency draft guidance on submission of quality metrics data can move forward. “PhRMA respectfully requests that FDA pause its efforts to implement the revised draft guidance … and the associated program timelines to allow such necessary dialog and issue resolution between industry and FDA,” the association says in a comment letter. “While we acknowledge and appreciate FDA’s extensive dialog with industry to date and recent inclusion of some of our prior recommendations in FDA’s approach, we now believe that the burden and timing of both industry and FDA collecting company-submitted quality metrics data outweigh the stated potential benefits to the extent that we do not support the program moving forward as currently proposed without further dialog.”
The association letter contains specific comments for FDA’s use should the agency still decide to move forward rather than pause its efforts.
In its comment, the Biotechnology Innovation Organization (BIO) says that metrics, when contextualized, tested, and appropriately defined, have the potential to provide a valuable tool to quantify product quality. “However,” it continues, “we reiterate that any metrics collection must have the appropriate benefit/burden balance for both the agency and industry.” BIO provides suggestions for implementation, assessment, data confidentiality, reporting for certain covered establishments, quality metrics FDA intends to calculate, quality metrics data that may be reported, quality metrics reporters list, and text comments.
In its response, the International Society for Pharmaceutical Engineering (ISPE) provides many extensive comments with findings from its own four-year quality metrics program and recommendations for simplifying FDA’s proposed program to increase its value to both the agency and industry. “ISPE comments on the revised draft guidance are extensive and have led ISPE to conclude that the program, based on our analysis, as proposed has little or no value and the burden is substantial,” the letter says. “Consequently, ISPE recommends that FDA issue a final guidance for a carefully structured FDA pilot program…. We suggest that such a limited pilot program and associated guidance should be designed and agreed with industry representatives to clarify requirements and value related to the burden.”
Finally, the Parenteral Drug Association says it is “concerned that there remain questions on metric definitions/data points and logistics that need to be resolved before companies can prepare data for submission during the voluntary phase.” It recommends that FDA develop an additional question-and-answer document to address comments received on the revised draft to help clarify the request and encourage firms to participate in the voluntary phase of submitting data.