In July 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance for industry requiring manufacturers to provide certain manufacturing data on an annual basis. The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research plan to collect and analyze this enormous amount of manufacturing data to help the Agency set its required risk-based inspection schedule. Additionally, FDA hopes this data will help them better understand how it can help companies drive improvements in manufacturing technology and product quality and potentially help mitigate the unlikely possibility of drug shortages.
Beyond the immediate logistical compliance challenges, there is concern FDA lacks the authority to roll out a mandatory quality metrics program. The FDA can only compel the submission of the quality metrics data through the notice-and-comment rulemaking process. Given FDA’s extensive engagement with stakeholders, and the close alignment between the aims of FDA and industry, the rulemaking process could be completed within an initial two-year voluntary implementation phase.
A phased-in approach would provide greater flexibility and certainty for such an innovative and transformative approach to regulation. This approach could span five years with an initial two-year voluntary period and include milestone reviews against predetermined criteria. This thoughtful approach provides the Agency with enough time to address concerns around issues of transparency and confidentiality, operability and legal authority.
By taking a phased-in approach, the FDA and biopharmaceutical companies would receive the following benefits:
- FDA gains meaningful and committed industry partners to assist in developing the quality metrics program.
- FDA avoids potential unintended consequences or effects on industry’s ability to manufacture medicines, which could disrupt the production of high-quality medicines for patients.
- FDA can ensure the specific metrics will first be evaluated and assessed for objectivity and interpretation variability in delivering desired outcomes. Additionally, FDA can ensure any standardized reporting format will balance an undue burden on industry with the need for comparable and meaningful data collection.
An initiative as significant as the quality metrics program should be undertaken in a manner that provides the greatest likelihood of success. As outlined in PhRMA’s recently released proactive policy solutions, modernizing the drug discovery and development process through pro-patient, pro-science, pro-market reforms at the FDA is needed to better serve patients.
We look forward to continuing to work with the FDA to ensure the quality metrics program supports the shared goal of protecting and promoting public health and patient safety, now and into the future.
Camille Jackson Camille is a Senior Director of Science and Regulatory Advocacy at PhRMA. An experienced scientific program administrator, Camille has worked with academia, government, non-profit organizations, and the pharmaceutical industry. She currently serves as the PhRMA coordinator for regulatory harmonization efforts within the International Conference on Harmonization (ICH) and the program manager for global quality and manufacturing initiatives.