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Quality Metrics: BIO Comments on FDA Draft Guidance Request for Quality Metrics

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In general, BIO is supportive of FDA&rsquo;s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA&rsquo;s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA&rsquo;s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. 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. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.</div>

Dear Sir/Madam:
 
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance entitled “Request for Quality Metrics” (Draft Guidance).
 
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and
environmental biotechnology products.
 
In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. 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. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.
 
We recognize that the FDA is requesting reporting of data and that the calculation of the metrics will be performed by FDA. It would be helpful if the Agency were to define the calculations that they envision performing with the reported data and any weighting they may envisage in establishing the overall risk quotient from this information.
 
Of significant importance is establishing a small number of key metrics that are clearly defined and generated in a consistent manner. It is also important to ensure that the terminology used is well-defined and as specific as possible. The effort taken to prepare these metrics should be commensurate with the value they provide in establishing or predicting the quality status of a manufacturing site or product. BIO sees this initiative as a journey and this Draft Guidance as a first step. 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. Additionally, as this program and its metrics collection may be substantially different from current practice, it will likely take covered establishments additional time, iterations, and resources to be able to complete these activities. We believe that open dialogue between FDA and industry will be a key factor in the success of this program. BIO members are committed to manufacturing high-quality products for patients and fully support the underlying goals of this program.