Promoting continuous manufacturing in the pharmaceutical sector

Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.