New FDA Team to Spur Modern Drug Manufacturing

To encourage adoption of advanced manufacturing technologies that can help industry meet high quality standards consistently, and avoid drug recalls and shortages, FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and overcome roadblocks. The new team will facilitate the inspection and review of manufacturing facilities where modern pharmaceutical development and production approaches are involved, explained Mansoor Khan, director of the division of product quality research in CDER’s Office of Testing and Research (OTR). Khan noted at the PDA/FDA annual regulatory conference in September that the ETT also would share information on new approaches in manufacturing quality with other regulatory authorities to encourage common oversight approaches to modern pharmaceutical production over the long term.

The ETT would be a part of the new Office of Pharmaceutical Quality (OPQ) still seeking final government approval and include experts from OTR plus other CDER offices and inspectors in FDA’s Office of Regulatory Affairs. One aim is for drug review staffs to engage early with inspection offices to support manufacturers looking to implement new technologies, commented CDER director Janet Woodcock at the FDA/PQRI conference on evolving pharmaceutical quality.

This initiative, she added, also may help companies implement systems able to quickly scale up production of new breakthrough therapies and to meet global health emergencies, such as the Ebola crisis. The demand for surge capacity in pharmaceutical manufacturing requires “agile, responsive systems that can deliver quality products to the public reliably,” Woodcock observed.

She also expressed optimism that the public demand for fast access to important new therapies and emergency treatments will lead to a better understanding of the complexities and challenges involved in producing quality biopharmaceuticals. Doctors tend to think that the “Easter bunny brings drugs to the pharmacy every night,” she quipped at the PQRI conference, noting that the public has little understanding of how drugs are made. No one wants to hear that it can take years to stand up a new production facility and to validate the process, she commented. But she is hopeful that this and other CDER quality manufacturing initiatives can help meet the demand for more efficient drug production.