From our perspective: Patients deserve quality medications

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Lawrence X. Yu, Ph.D., Acting Director of FDA’s Center for Drug Evaluation and Research’s Office of Pharmaceutical Science, discusses the important roles of FDA and drug companies in ensuring quality drug products.

Drug quality -- a shared responsibility 

Lawrence X. Yu, PhD

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 U.S. 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.

One quality voice

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 percent – 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 Harmonisation guidances on Process Analytical Technology, Pharmaceutical Development, Quality Risk Management, and Pharmaceutical Quality Systems. Still, we see a growing dichotomy in pharmaceutical manufacturing. There has been gradual acceptance of new technologies and enhancements in both product development and quality systems. Nevertheless, the American public is facing unprecedented drug shortages and recalls. Industry and the FDA have the shared obligation to reduce quality errors and provide high quality medications to the American public.

To fulfill this responsibility, both industry and the FDA need a culture of quality. A true quality culture is an environment in which the entire organization not only follows quality guidelines but also is focused on continuous improvement. It is important to recognize that financial incentives don’t always reduce errors. Employees must be passionate about eliminating mistakes and making quality their driving principle.

Stepping up our efforts: A new office at CDER focused exclusively on quality

Patients should have access to quality medicines no matter where they purchase the product and regardless of whether the medications are non-prescription, prescription, brand name, generic, or if they were produced by a traditional compounding pharmacy or a conventional manufacturer. Quality is the foundation for assuring drug performance and should be a key consideration for both regulators and manufacturers at every step of the drug lifecycle.

I have been watching the pharmaceutical industry grow and change for many years. And over the years we at FDA have adapted our organizational perspective to proactively deal with the increasing complexity of the industry and its products. The Office of Pharmaceutical Quality (OPQ), due to “stand-up” in January 2015, is one response to the need for a robust regulatory quality oversight program in a changing industrial environment. OPQ intends to be a global benchmark for regulation of pharmaceutical quality.

OPQ will strive to achieve the goals laid out in FDA’s 21st Century Quality Initiative by streamlining the drug quality work that is currently being done in multiple parts of our center to provide seamless assessment and surveillance over the product lifecycle.  This new office will closely integrate review, inspection, surveillance, policy, and research in an effort to provide one unified view on pharmaceutical quality.

As part of CDER’s heightened focus on quality, OPQ will work to balance regulatory resources between pre-marketing evaluation and post-marketing surveillance, and transform product quality oversight from a qualitative to a quantitative and expertise-based process. OPQ will employ risk-based approaches in our regulatory evaluation, surveillance, and inspection to maximize economy of time, effort, and resources. We aim to provide aligned quality recommendations that are inclusive of drug substance, drug product, manufacturing, and facilities.

Proactive Approach Aids Quality

We have found that temporary fixes by manufacturers are not enough because quality issues often reflect broader, organization-wide quality problems. When a drug company has a robust quality oversight program, we see far fewer quality issues with its drugs. However, our new, more proactive approach will help us identify a problem quickly and take prompt action before it can escalate.

As mentioned above, we are working to establish risk-based measurements that identify quality issues more rapidly and enable us to respond quickly before they become major, systemic problems. We will use performance measures to help us know the current state of quality of both facilities and products. With this information, we can make better decisions on when to conduct surveillance or take regulatory action if a company demonstrates a pattern of being unable to achieve quality standards.

Committed to Helping Keep Patients Safe

At the end of the day, it’s the patients who rely on their medications and who suffer the consequences of poor quality; I find that deeply troubling. Providing patients with substandard or contaminated medications is simply unacceptable. As a regulator, I’m committed to helping to keep patients safe from unnecessary risk by fostering a quality-focused industry and regulations. Patients deserve it.


Dr. Lawrence X. Yu joined FDA in 1999 as a team leader in CDER’s Office of Pharmaceutical Science’s (OPS) Division of Product Quality Research, and was later promoted to deputy director in the Office of Generic Drugs. He currently serves as Acting Director, OPS, adjunct Professor of Pharmaceutical Engineering at the University of Michigan, and Associate Editor of AAPS J. Dr. Yu received a B.S. in Chemical Engineering from Zhejiang Institute of Technology, China; M.S. in Chemical Engineering from Zhejiang University, China; M.S. in Pharmaceutics, University of Cincinnati; and a Ph.D. in Pharmaceutics, University of Michigan. Before joining FDA, Dr. Yu worked at both Glaxo and Pfizer (Pharmacia & Upjohn).

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