Proposed quality metrics program raises operability questions

The proposed quality metrics program is a substantial undertaking, and its rollout will require significant resources from both industry and FDA.

Guest ContributorMarch 25, 2016

Proposed quality metrics program raises operability questions.

FDC_PhRMA.Catalyst.Blog.jpgPreviously in this blog series, we’ve discussed PhRMA’s main recommendation for a phased-in approach to the U.S. Food and Drug Administration’s (FDA) proposed quality metrics program, as well as concerns related to issues of transparency and confidentiality. In addition to these concerns, PhRMA anticipates challenges related to the operability of FDA’s quality metrics program.

The proposed quality metrics program is a substantial undertaking, and its rollout will require significant resources from both industry and FDA. The burden on drug manufacturers to comply with the proposed quality metrics program as it is currently envisioned will be significant, and PhRMA believes FDA’s burden calculations are significantly underestimated.

While PhRMA member companies currently calculate and evaluate their own quality data to maintain high product quality, there is tremendous variability in how such data are documented and tracked from one company to the next. Standardization across the industry will be required in order to allow meaningful interpretation of quality metrics data submitted to FDA from across the industry.

While representatives from PhRMA member companies are supportive of FDA’s intent, such standardization efforts across industry are challenging. Detailed, precise definitions will need to be established by the FDA to ensure that the submitted data can be interpreted consistently across companies to facilitate realization of the benefits from the program by both FDA and industry in the near future. PhRMA believes there is a need for more dialogue between FDA and industry in order to achieve such standardization.

Consequent to such standardization efforts, it is anticipated that PhRMA member companies will need to overhaul their own established processes and procedures in order to collect information in the precise format and manner FDA is requesting. The likelihood of such substantial reconfigurations of company systems and underlying processes is a significant hurdle that industry considers to be underestimated in FDA’s burden calculations. The International Society for Pharmaceutical Engineering (ISPE) performed a pilot study of the quality metrics program and concluded that the program would require significantly more effort than FDA is currently estimating. A phased-in approach allows for a more dynamic evolution of the program and will help enable the true burden on manufacturers to be evaluated against the benefits in determining the program’s success.

Continued dialogue and collaboration between FDA and industry regarding the burden estimate is strongly encouraged and will be important throughout a recommended phased-in approach to the quality metrics program. This dialogue will help to inform further decision-making regarding program design and will also increase the likelihood of widespread program adoption by companies during PhRMA’s recommended voluntary implementation period. With a phased-in approach, FDA can focus on assessing the program’s burden and ensuring that the program will be able to deliver corresponding benefits.

Our final post on this topic will discuss FDA’s legal authority, as well as additional benefits of PhRMA’s main recommendation for FDA to adopt a phased-in approach.


Mairead Goetz has over 25 years of experience in the pharmaceutical industry, including roles in all areas of quality and compliance over her time at Novartis, Merck and Schering Plough. 

Mairead is currently head of compliance for Novartis in the group quality compliance & audit organization. In this role, Mairead has compliance oversight for Novartis across business units/divisions through risk-based system assessments, including health authority inspections and quality metrics.  

Mairead has deep, cross functional experience in quality and business process reengineering and is a Lean Six Sigma Certified Black Belt.   

Mairead currently leads ISPE’s quality metrics team and formerly led their quality metrics industry engagement team. Mairead holds a Bachelor of Science in Chemistry from University College Cork, Ireland.

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