FDA’s acting director explains aims of new Office of Pharmaceutical Quality

This week the Acting Director of US Food and Drug Administration’s Center for Drug Evaluation and Research’s Office of Pharmaceutical Science Lawrence Yu discussed the important roles of FDA and drug companies in ensuring quality drug products.

He argued that consumers expect and deserve access to safe, effective, high-quality drugs and it’s up to both the FDA and manufacturers to make sure that they are available. It is FDA’s job to establish standards, conduct pre-marketing reviews and inspections, and perform post-marketing surveillance and investigations to safeguard that all US marketed drugs are safe, effective and of adequate quality. Drug companies have a responsibility to meet these standards to ensure that quality products reach patients.

He said: “Failures in drug quality put patients at unnecessary risk. When quality issues arise in manufacturing facilities, product recalls and plant shutdowns can follow, often resulting in drug shortages. By far, the most frequently cited reasons – approximately 65% – for drug shortages relate to manufacturing and quality issues. These quality issues mainly occurred in sterile injectable drug products and range from sterility problems to products contaminated with particles of glass, metal or other materials. However, in the past decade, we have seen progress toward quality pharmaceutical manufacturing through the issuance and adoption of FDA and International Conference on Harmonization guidances on Process Analytical Technology, Pharmaceutical Development, Quality Risk Management, and Pharmaceutical Quality Systems. Still, we see a growing dichotomy in pharmaceutical manufacturing.”