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Dec. 2 — Branded and generic pharmaceutical industry groups have concerns with the FDA's draft guidance on quality metrics, especially in the area of data reporting.
In recent comments, the industry groups said the Food and Drug Administration has underestimated the significant costs and burdens for manufacturers in collecting and reporting quality metrics data. They said the agency should phase in these requirements. They also said the FDA should use a rulemaking process, rather than a draft guidance, to implement the quality metrics program.
Also, a biotechnology industry group said the FDA should more clearly state the intended use of the collected metrics and the benefits to industry.
The draft guidance was released July 27 (13 PLIR 1090, 7/31/15). A notice announcing the draft guidance was published in the July 28 Federal Register (80 Fed. Reg. 44,973). In the Aug. 26 Federal Register (80 Fed. Reg. 51, 822), the FDA extended the comment period until Nov. 27 (13 PLIR 1255, 8/28/15). Comments had been due Sept. 28. The agency will consider the comments as it works on the final version of the guidance.
Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and “drive continuous improvement efforts in drug manufacturing,” the draft guidance said. “These metrics can also be used by FDA: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the agency's ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) said in its comments that “the implementation plan set forth in the draft guidance would benefit from significant revisions to ensure that the quality metrics program is successful in both improving manufacturing quality overall and achieving resource efficiencies for the agency.”
PhRMA said it agrees that reporting quality metric data can be an important part of the FDA's overall quality surveillance practices and has benefits for both the agency and regulated industry. “However, PhRMA is concerned that FDA is substantially underestimating the burden that manufacturers will encounter in collecting and reporting such information,” the group said.
Collecting and organizing metrics data from a network of sites involved in the supply chain “will present significant challenges,” PhRMA said. “Furthermore, there are still open questions on who will collect, consolidate, and report the quality metrics data, which are in turn influenced by how the data are to be structured (e.g., by the establishment or by the product) and this further confounds an accurate assessment of the burden on industry.”
“Because of this, the process of conforming firms' practices for consistency with FDA expectations for collecting and reporting quality metrics data will, at least in the short term, likely require significantly greater time and investment than estimated by the agency,” the group said.
PhRMA said it “strongly” suggests that the FDA “use a voluntary, phased implementation approach, which will provide ample opportunities for evaluation and optimization of the quality metrics program.”
“Such an approach will also mitigate any unnecessary burdens being placed upon FDA and industry, as well as prevent any unintended consequences that can arise when embarking on such an innovative and transformative approach to regulation,” PhRMA said. “Moreover, any mandatory program subject to enforcement action could be implemented only via formal rulemaking.”
The FDA should use a rulemaking process because not doing so would make the quality metrics program “unnecessarily vulnerable to legal challenge after PhRMA member companies have invested millions of dollars and countless hours in preparing to meet the program's requirements,” the industry group said. “PhRMA also strongly encourages FDA to publicly state its commitment to carefully balancing the benefits of transparency in how quality metrics data are analyzed and used with the need to protect confidential commercial information.”
The Generic Pharmaceutical Association (GPhA) said in its comments that the draft guidance “is legally flawed in that it proposes requirements that exceed the agency's statutory authority, is contrary to law, and fails to consider important aspects of the problem it seeks to address.”
The GPhA said promulgation of regulations, not drafting guidance, “is the proper mechanism for imposing a new binding quality data-reporting regime on industry.” If the FDA's draft guidance were implemented, the FDA “would have no legal basis for initiating enforcement actions against companies that failed to comply,” the GPhA said.
Also, the generics group said the FDA “has failed to accurately account for the significant costs and burdens associated with its proposal; the reasonableness and workability of the proposal are fundamentally affected when these costs are taken into account. Also, the costs, burdens, and ramifications of compliance may negatively affect drug availability and may undermine the robustness of existing quality assurance programs.”
David Gaugh, senior vice president for sciences and regulatory affairs at the GPhA, said in a Nov. 30 statement on the draft guidance that the FDA should consider additional actions to make sure any proposed changes don't cause supply disruptions.
“For example, the quality metrics program could start with a phased introduction. A phased approach is one way to maximize learnings for industry and FDA while limiting avoidable burdens on manufacturers,” Gaugh said. “A phased approach can also ensure that the nation’s generic and brand pharmaceutical manufacturers are able to develop the infrastructure needed to comply with these new inspections.”
The Biotechnology Industry Organization (BIO) said in its comments that “it would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry.”
“We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity,” BIO said.
BIO said it recommends that the FDA “clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only” and “FDA will not take compliance actions solely based on quality metrics data evaluation.”
Also, BIO requested that the FDA provide clarity regarding the extent to which the FDA's Center for Biologics Evaluation and Research (CBER) will implement this new approach for the facilities it inspects.
“BIO sees this initiative as a journey and this draft guidance as a first step,” the group said. “We note that it will likely take several iterations to arrive at metrics and definitions that provide optimal value as well as to ensure the collection and submission of the quality data points are efficient.”
The FDA should implement a two-year assessment period where data are collected from industry and the agency can have a dialogue with stakeholders before officially putting the metric data into the inspections risk model, BIO said. “This will allow stakeholders to coalesce around a set of metrics and definitions that will provide optimal value to FDA. An assessment period will also allow FDA and industry to identify and unintended consequences that may arise from the collection of these metrics.”
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The draft guidance is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455957.pdf.
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