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  1. Center for Drug Evaluation and Research | CDER

Report on the State of Pharmaceutical Quality

Director's Message

Quite simply, everyone deserves confidence in their next dose of medicine. A quality medicine is safe, effective, and available for the people who need it. Drug manufacturers are responsible for complying with regulations and ensuring their products meet quality standards. The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. This is not an easy mission, but it is a critically important one.

As the new Fiscal Year 2022 Report on the State of Pharmaceutical Quality explains, our catalog includes more than 4,800 manufacturing sites around the world making more than 140,000 drug products for U.S. patients and consumers. Most of these manufacturing sites are located outside of the U.S.  While 90% of the 227 drug and biological products deemed to be essential medicines have at least one manufacturer in the U.S., most active pharmaceutical ingredients are made solely by foreign manufacturers.

To further complicate matters, the quality of a finished drug product depends on several factors. These include the quality of the process that made it, the facility that housed the process, and the supply chain that feeds to and from the facility. With this complexity, it is not realistic to use one tool to assure quality all the time. However, overlapping surveillance tools, such as these, make it more achievable:

  • Drug Sampling and Testing

    Manufacturers are responsible for designing and implementing processes that produce drugs that meet high quality standards. Since no single entity can sample and test 140,000 drug products, FDA uses risk-based analytics to target and test potentially noncompliant products. We do this using appropriate and validated methods to avoid erroneous findings. This is a strategy that proved effective in 2022 as 57.5% of 1,552 samples tested were found to be noncompliant, the majority of which were imported. Since FDA takes action when finding these substandard products, it is important that such sampling and testing be done right.

  • Surveillance Inspections

    Since sampling and testing is not the sole solution, OPQ also surveils the entire U.S. pharmaceutical market using complementary tools such as inspections. Facility inspections have, for good reason, long been the calling card of FDA. Though surveillance inspections nearly tripled in 2022, travel restrictions due to the COVID-19 pandemic continued to pose challenges. Fortunately, we were able to conduct remote regulatory assessments of facilities by using tools such as records requests and Mutual Recognition Agreements with other trusted global regulators.

  • Analyzing Quality Defects

    Another important tool is the analysis of product quality defects. This is done in part by examining field alert reports, in which application holders must notify FDA about significant product quality defects within three working days. Field alert reports decreased by 15% in 2022, owing to less demand for potentially problematic injectable products.

Taking Action and Moving Forward

Michael Kopcha, Ph.D., R.Ph.
Michael Kopcha, Ph. D., R.Ph., Director of the Office of Pharmaceutical Quality

When we find significant problems with any drug product or facility, we act. In 2022 alone, FDA issued 28 import alerts, handled 912 product recalls, and issued 72 warning letters to facilities. Most of the sites receiving warning letters (68%) were manufacturers of non-sterile, non-application products (which include over-the-counter products), though such sites represented only 30% of inspections.

FDA could benefit from having more information about the amount of drug products in commercial distribution. This would help FDA work with other parts of the federal government and industry to better address drug shortages. Manufacturers must now annually report the amount of each listed drug in commercial distribution to FDA. Yet, by the end of 2021, the distribution amounts for more than three-quarters of drugs had not been reported. There is still work to do, and FDA can’t do it alone. Please read our latest report, and let’s all work together to improve the state of pharmaceutical quality for the sake of U.S. patients and consumers.

Previous Reports on the State of Pharmaceutical Quality


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