Posted October 10, 2017 - phillipgilbertlaw.com
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.
“Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in.”
The new dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe. In addition to making it easier for consumers to search for adverse events reported with drug or biologic products, the FDA hopes the increased transparency will spur the submission of more detailed and complete reports from consumers, health care professionals and others, by making it easier for people to see other reports that the FDA receives, and search the database for similar observations.
The FDA uses FAERS for surveillance, such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer’s compliance with reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to monitor the safety of products after they are marketed. If a potential safety concern is identified in FAERS, further evaluation is performed.
“Our focus on safety extends beyond approval,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “In fact, our staff spends a lot of time looking at FAERS reports received regarding approved drug and biologic products and these reports can be very valuable components of our safety assessments. By giving people a better understanding of these data, and the associated limitations, we hope the new interface will encourage people to submit more complete reports.”
While the FAERS dashboard now offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should still talk to their health care professional if they have any concerns regarding their medications.
In addition to the FAERS database for drugs and biologics, the agency has adverse event reporting programs and databases for foods, dietary supplements, and cosmetics (CFSAN Adverse Event Reporting System, or “CAERS”), medical devices (Manufacturer and User Facility Device Experience, or “MAUDE”) and vaccines (Vaccine Adverse Event Reporting System, or “VAERS” that the FDA co-manages with the Centers for Disease Control and Prevention).
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of drug and biologic products to the FDA’s MedWatch Adverse Event Reporting program. To do so:
- complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.