Overwhelming Response from Industry on FDA’s Guidance on Quality Metrics
The drug industry flooded the regulations.gov website with comments on FDA’s Request for Quality Metrics, with many of the comments coming in the form of concern over how manufacturers will report their data to the agency and how the data will be used by the agency to guide further regulatory action. Further, many commenting companies questioned who in the supply chain would ultimately be responsible for reporting to FDA—as well as what specific data would be necessary, how these data would be interpreted to assess overall product quality, and how to determine whether a quality program was successful or not. Questions were also raised about the methods of reporting that would be required and the overall burden to the industry as far as adding resources to perform quality testing, which Sanofi said in a comment could “increase the potential for drug shortages because some companies may make choices based on FDA metrics to the detriment of the drug supply, by discontinuing products, increasing drug prices, or diverting resources from other quality activities.” Sanofi even questioned FDA’s legal authority to collect metrics and the agency’s ability to take enforcement action if a site does not submit a quality metrics report.
Source: Biopharminternational
