FDA takes new steps to increase access to adverse event report data

Today, the U.S. Food and Drug Administration announced it is making available online the adverse event reports related to animal drugs and medical devices used in animals. The reports will go back 30 years. They will be available electronically on openFDA.gov, an agency-run digital platform used by researchers, statisticians and other academics to access large, valuable public health datasets collected by the FDA. This action is part of a broader effort by the agency to increase the transparency and sharing of adverse event report data related to the medical products that the FDA regulates.

“The FDA has made it a priority to enhance transparency and information sharing across our entire portfolio of regulated products, especially when the availability of such information can benefit human and animal health. This action to make available adverse event reports related to drugs and medical devices used in animals is the latest step in our ongoing effort to provide greater access to data from adverse event reports across our entire portfolio, including human drugs and medical devices,” said FDA Commissioner Scott Gottlieb, M.D. “The reports being added today to openFDA can be valuable to all those involved in animal care by helping animal health providers identify and prevent potential harms. This is data we use every day at the FDA to identify potential safety concerns that weren’t known at the time of approval. By providing greater access to this important information, we hope stakeholders will be able to leverage the data to expand the body of knowledge related to the safety of medical products intended for animals.”

The information made available on openFDA comes from the FDA’s Center for Veterinary Medicine’s (CVM) Adverse Event Reporting (AER) system, one of the post-market surveillance tools that the FDA uses to monitor the animal and human user safety of drugs and medical devices used in animals, as well as the effectiveness of these products. This detailed level of data was previously only available via a Freedom of Information Act request. As a result of the action the agency is announcing today, it is available electronically to the public and accessible for automated searching on openFDA.gov. Information about adverse events reported by veterinarians, animal caretakers and pet owners is also included.

Making adverse event data public and accessible is part of the FDA’s overall commitment to transparency and its goal of enabling the availability of open data for the benefit of public health and safety. The availability of adverse event report data on animal drugs and medical devices used in animals in openFDA follows other agency efforts related to ensuring public access to safety-related information.

For example, in 2017, the FDA launched a new dashboard that improves access to data on adverse events associated with drug and biologic products in its database called FAERS (FDA’s Adverse Event Reporting System). These improvements enable 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. Also that year, the FDA modified the conditions of one of its adverse event reporting programs for human medical devices, called alternative summary reports (ASR), to begin making the summaries available in its existing public facing medical device reporting database known as MAUDE (Manufacturer and User Facility Device Experience). To further advance transparency, the FDA stated last week that it is developing ways to make ASR data received prior to 2017 more easily accessible by users.

Manufacturers of FDA-approved animal drugs are required to report adverse events associated with their products to the agency. Pet owners and animal producers, as well as both animal and human health care providers, may elect to voluntarily report to the FDA adverse events involving approved and unapproved drugs, as well as medical devices used in animals.

This first posting of data to be made publicly available on openFDA.gov includes approximately 865,075 adverse event reports submitted between Jan. 1, 1987 to April 3, 2019. The reports are associated with approved animal drugs, unapproved/compounded drugs and medical devices used in animals. The FDA will upload new data received via the CVM AER system to openFDA.gov on a quarterly basis, which will also include voluntary reports from a variety of sources, including pet owners, animal producers, veterinarians and other health care providers.

“It cannot be stressed enough how important detailed adverse event reports are in helping the FDA identify and investigate potential concerns about the safety or effectiveness of drugs or medical devices used in animals, as well as their potential impact on the safety of people administering these products,” said Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine. “While we recognize that this data is valuable to the research community, healthcare providers and beyond, it is also important to note that it is just one of many datasets that helps inform the agency of possible problems associated with a product and there are important limitations to the data.”

The FDA uses CVM AER data as one way to monitor the safety of drugs and medical devices used in animals by identifying trends and potential safety issues. The agency’s review and analysis of data from these reports can help to identify possible safety and efficacy concerns and add to our body of knowledge about the product or category of products. Review of this data can also lead to safety alerts or label changes, and in some cases, additional regulatory and enforcement actions.

However, there are limitations to the data and it is important to note that the information in both openFDA.gov and the CVM AER system is as reported to the FDA, and the agency has not necessarily determined if the products in question were the actual cause of the events being reported. OpenFDA, an FDA Office of Health Informatics initiative launched in June 2014, makes it easier for researchers, scientists, web developers, and other FDA regulatory stakeholders to access and use the datasets in an open standard format. To learn more, visit openFDA.

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.