FDA's requirements for approval of new drugs, generic drugs, and biologics are among the highest standards across the globe. Prior to FDA approval, manufacturers of prescription drugs must prove their drug is safe, effective, and of high quality. Manufacturers of non-application drugs, including many over-the-counter drugs, are also responsible for meeting legal U.S. quality standards. To help ensure manufacturers are producing high-quality drugs for sale in the U.S., CDER maintains a comprehensive quality surveillance program.
CDER conducts routine sampling and testing of selected drugs on the market as well as risk-based, targeted sampling and testing of drugs. Information on risks can be based on data from inspectors, manufacturers, distributors, and wholesalers, as well as directly from consumers and patients.
CDER’s Office of Pharmaceutical Quality (OPQ) oversees the quality surveillance program. Guided by information on the State of Pharmaceutical Quality, expanding product knowledge, and the availability of more sophisticated testing methods, OPQ began to adopt a more targeted, risk-based approach to drug sampling and testing beginning in 2018. This approach has been effective in identifying more products per year that do not meet quality standards than in previous years.
In this CDER Conversation, we sit down with Jennifer Maguire, director of the Office of Quality Surveillance in OPQ to learn more about the drug quality sampling and testing program.
How does CDER’s drug quality sampling and testing program work?
Pharmaceutical manufacturers, no matter where they are located, are responsible for guaranteeing that only quality products reach U.S. patients and consumers. Product testing is the responsibility of manufacturers of all marketed drugs, including prescription and over-the-counter, to make sure their products conform to the appropriate quality standards. OPQ’s mission is to assure that quality medicines are available to U.S. patients and consumers. We protect patients and consumers from poor-quality drugs by determining if companies are fulfilling their responsibilities and initiating appropriate action if they are not. Actively selecting and testing drugs, known as postmarket surveillance testing, is one way OPQ makes this determination.
FDA laboratories test drugs and the active pharmaceutical ingredients used to make them. We test approved drugs with the same standards used in the drug approval process. For example, we may test for identity, strength, and purity, as well as bioavailability, which is the rate that the drug is absorbed into the bloodstream over a period of time.
OPQ samples drugs for general quality surveillance and for targeted investigations in response to information about suspected quality issues with drugs on the market. The information we analyze through our drug quality sampling and testing program can be used to understand the state of quality for particular products or classes of products, identify defective or potentially harmful products, and provide evidence for compliance actions.
As part of CDER’s quality surveillance program, sampling and testing complements other surveillance approaches to ensure product quality including inspecting manufacturing facilities, evaluating postmarket quality reports, and using data analytics.
How does OPQ decide which drugs to test?
Prior to 2018, agency testing found that a very low percentage of drugs did not meet quality standards. This included drugs tested as part of the largest ever FDA sampling study of difficult-to-make pharmaceutical products. All of the drugs tested in this international sampling study met quality standards, regardless of whether the drug was manufactured in the U.S. or in a foreign country.
Beginning in 2018, CDER has released an annual Report on the State of Pharmaceutical Quality, which in part has informed our surveillance activities and allowed us to adopt a more targeted, risk-based approach to better prioritize the drugs we sample and test. With more than 150,000 products in CDER’s surveillance catalogue, it is not feasible for any one party, including FDA, to test all drugs. Focusing on drugs with quality risks helps to minimize potential harm to consumers and patients and allows FDA to use our resources in a manner that will have the most impact. Product sampling and testing is only one surveillance tool and, since targeted sampling focuses on products with suspected quality issues, violative products tend to bias the overall testing data.
In cases where information suggests that products are of suspect quality, OPQ samples the product and performs specific tests to investigate whether the product meets quality standards. For example, if an active pharmaceutical ingredient has the potential to become contaminated with a harmful impurity during the manufacturing process, OPQ tests for that specific impurity. This targeted approach for sampling and testing has been effective in identifying more products that failed to meet quality standards than in years prior to 2018.
Where can someone find CDER’s drug quality sampling and testing results?
We post our testing results so the public can better understand the quality of the U.S. drug supply. We recently updated this site with testing results from 2018-2021.
Since 2018, we’ve prioritized releasing the annual Report on the State of Pharmaceutical Quality, addressing quality-related issues with manufacturers directly, and sharing alerts for specific quality risks via other targeted communications. For example, we communicated regarding issues related to hand sanitizer products, nitrosamines, and benzene contamination. In addition, FDA provides information to consumers about product risks on its Recalls, Market Withdrawals, & Safety Alerts web page. In the future CDER plans to share these data annually.
Even though certain products have failed to meet quality standards, we continue to find that the vast majority of legally marketed drugs meet appropriate quality standards.
What does CDER do with testing results?
Our work doesn’t end at testing. When our testing finds drugs that do not comply with quality standards, we work swiftly to protect the public from potential harm.
If test results indicate a quality risk, we may alert manufacturers of the need to correct underlying problems. If necessary, we recommend manufacturers remove drugs that do not meet quality standards from the marketplace through a recall. FDA takes decisive and swift regulatory action to protect patients and consumers from risks presented by poor quality and unsafe drugs. Some products that fail tests may have a quality risk that is only relevant for the particular batches tested at that point in time. In such cases, we work with the manufacturers to make certain future products meet quality standards. We continue to monitor the situation until manufacturers demonstrate compliance with FDA rules and regulations.
We also provide health care professionals and consumers with information they need to make informed decisions. Our testing has identified potentially dangerous drugs and allowed us to alert consumers and initiate action to remove these products from the marketplace. For example, to address the contamination of some hand sanitizer products with harmful substances such as methanol, we published a list of hand sanitizer products that consumers should not use. FDA also established a new laboratory test legally required to be used by manufacturers of hand sanitizer products. Our surveillance and import testing enabled FDA to initiate the first human drug related countrywide import alert for hand sanitizers from Mexico due to the large number of products coming from that country containing methanol or other contaminants.
What can patients and consumers do if they are concerned about the quality of a drug?
If you have a concern about the quality of a drug regulated by FDA, the agency wants to hear about it. OPQ uses these reports to track potential public health risks, determine if further analyses and actions are needed, and identify products for sampling and testing.
Both patients and health care professionals can report concerns to FDA. To report complaints about FDA-regulated products please use MedWatch.
CDER has ongoing assessment, surveillance, compliance, and pharmaceutical quality efforts across every product area, and we work with drug manufacturers to ensure the availability of safe, effective, quality drugs for the American public.