America’s innovative biopharmaceutical companies are leaders in innovation and quality—not just in research and development, but also in manufacturing technology.
PhRMA’s member companies implement extensive continuous improvement initiatives for their manufacturing facilities and invest billions of dollars in sophisticated manufacturing processes and robust quality systems necessary to bring consistent, high-quality innovative medicines to patients.
Our members have a strong commitment to maintaining high product quality and ensuring the safety of patients that’s demonstrated not only by complying with, but also seeking to exceed regulatory requirements in order to excel in manufacturing quality.
PhRMA supports the Food and Drug Administration (FDA) by routinely providing evidence-based input as the Agency formulates science- and risk-based regulations. PhRMA also seeks to support FDA in its mission to protect and promote public health by assuring the safety, efficacy, and quality of human drugs and biologics.
Since the publication of the Pharmaceutical cGMPs for the 21st Century in 2002, FDA has promoted a vision of "a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.” PhRMA supports this vision and acknowledges FDA’s efforts to implement it through the development of programs and guidance documents to maximize FDA’s limited regulatory resources to ensure a well-functioning global pharmaceutical supply chain.
In continued efforts to realize this vision, FDA issued a new draft guidance for industry in July 2015. The draft guidance describes the FDA’s proposal for a new quality metrics program wherein the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will attempt to collect and analyze an enormous amount of manufacturing data from drug manufacturers on an annual basis. FDA hopes these data will help them understand how the Agency can help companies drive improvements in manufacturing technology, product quality, and potentially even help companies mitigate drug shortages. FDA also wants to use these data as the Agency develops its statutorily required risk-based inspection schedule; the goal of this schedule is to make more efficient use of FDA’s inspection resources as it enforces its regulations throughout the global supply chain.
PhRMA has long supported FDA’s movement toward a risk-based inspection paradigm, and supports the Agency’s efforts to eventually introduce the use of quality metrics to help optimize the Agency’s risk-based inspection schedule. Given the large scale of the quality metrics program that FDA has outlined, PhRMA, as well as other groups throughout the industry, has provided significant suggestions on how to ensure the Agency’s ambitious endeavor is successful from the outset, both in achieving Congress’s goals and improving manufacturing quality across the industry.
PhRMA strongly recommends that FDA adopt a phased-in approach to rolling out this ambitious program. The phased-in approach would span five years with an initial two year voluntary period and include milestone reviews against predetermined criteria. This approach would alleviate concerns around transparency and confidentiality, operability and legal authority.
Our forthcoming post on this topic will elaborate on these concerns and also describe the benefits of PhRMA’s main recommendation for FDA to adopt a phased-in approach.
This blog post is the first in a series of posts on FDA’s proposed quality metrics program.