In our last post on this topic, we discussed PhRMA member companies’ commitment to quality and introduced you to the U.S. Food and Drug Administration’s (FDA) proposed mandatory quality metrics program. With the proposed program, FDA seeks to collect and analyze an enormous amount of manufacturing data from drug manufacturers on an annual basis. While PhRMA sees immense value in the Agency’s eventual use of quality metrics, the current proposal has significant challenges. PhRMA has offered constructive ideas for FDA’s consideration for improvement.
The goal of the quality metrics program is to provide FDA with data to help calibrate the Agency’s risk-based approach to inspections. Under a risk-based inspection paradigm, high-risk facilities would be inspected and monitored more often than high-performing facilities that have a reputation for producing quality products for patients. Such an approach facilitates efficient use of Agency resources while keeping patients safe. This goal is one which PhRMA strongly supports.
Undue inspections can be disruptive to a manufacturing site’s activities, which can be an unnecessary burden for high-performing facilities. Furthermore, the FDA’s inspection resources are finite and are best used in addressing high-risk facilities. For high-performing facilities that constantly invest in quality improvements and have robust compliance systems in place, the opportunity for fewer, but smarter, inspections is a strong incentive to support the quality metrics program. PhRMA member companies are already implementing extensive, continuous improvement initiatives for their manufacturing facilities and invest billions of dollars in the sophisticated manufacturing processes and robust quality systems necessary to consistently bring high-quality, innovative medicines to patients.
To ensure that the quality metrics program envisioned by FDA results in a risk-based inspection schedule that facilitates the consistent production of high-quality medicines, we believe the FDA should provide transparency on how the Agency plans to process, interpret and utilize the reported quality metrics data. Sharing this information is critical so that stakeholders can weigh in and provide feedback on whether such plans will generate unnecessary or unintentional additional burdens. A phased-in approach makes it possible to incorporate lessons learned by stakeholders over time, which will help FDA achieve its goal of having a quality metrics program that is “objective” and “valuable in assessing the overall state of quality” at any given manufacturing facility.
When providing transparency about the Agency’s plans, PhRMA also asks FDA to clarify that it will continue to protect manufacturers’ confidential commercial information when it collects quality metrics data. Such information must continue to be protected in order to avoid unintended consequences if the data were taken out of context, misinterpreted or misused. PhRMA has requested that FDA explicitly state it will protect biopharmaceutical companies’ confidential commercial information when used as part of the quality metrics program.
A phased-in approach to the quality metrics program would help to balance the potential benefits with any unnecessary burden for both the Agency and industry so that we can both continue to meet our shared goal of protecting and promoting patient health.
Our forthcoming post on this topic will discuss PhRMA’s concerns with FDA’s proposed quality metrics program and the issue of operability.
Sarah Spurgeon Sarah A. Spurgeon is Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) and serves as one of the principle food and drug law regulatory attorneys for the association. Ms. Spurgeon provides advice and advocacy on FDA regulatory and policy matters as well as legal counsel on federal legislation. Ms. Spurgeon’s substantive areas of expertise include the regulation of communicating information related to prescription medicines (e.g., REMS, PhRMA Code compliance, and FDAMA 114) and matters related the safety, security and quality of the global pharmaceutical supply chain (e.g., implementation of Title VII of Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Quality and Security Act (DQSA)). Prior to her role at PhRMA, she worked in a Washington, D.C. law firm’s internationally renowned Food and Drug Law practice group. Ms. Spurgeon received her B.A., cum laude, in American Studies and Economics from Wellesley College and her J.D., cum laude, from Harvard Law School.