The U.S. Food and Drug Administration has discontinued the MedWatch to Manufacturers Program (MMP) as of July 31, 2020. This program allowed participating drug and biologic manufacturers to receive information from the FDA on serious adverse event reports that are submitted directly to FDA by voluntary reporters for new molecular entities and original biologics for the first three years after approval.
Since the introduction of the FDA Adverse Event Reporting System (FAERS) Public Dashboard in 2017, manufacturers can now directly search and download publicly available information from adverse event reports in FAERS, including adverse event reports submitted voluntarily to FDA. The dashboard is a web-based tool that manufacturers and the general public can use to search for publicly available data from adverse events reports concerning a drug product. The dashboard provides transparency and direct access to publicly available data from individual case safety reports in FAERS. Discontinuation of the MMP will not impact access to publicly available information in voluntarily submitted adverse event reports as the dashboard allows access to publicly available FAERS data. The modernized dashboard provides public access to information related to human adverse events reported to the FDA by reporters including manufacturers and the general public. The dashboard does not provide case narratives; these can be obtained by submitting a (Freedom of Information Act (FOIA) request.
Current participants will receive a notification informing them of the discontinuation of the MMP. No new enrollment requests will be accepted or processed.
Questions and Answers
Why is FDA retiring this program?
FDA has determined that the MedWatch to Manufacturers program should be retired due to advancements with the FDA Adverse Event Reporting System Public Dashboard (FAERS Public Dashboard). The dashboard is a highly interactive web-based tool that allows public users to search and download publicly available information from adverse event reports in FAERS, including adverse event reports submitted voluntarily to FDA. The dashboard offers manufacturers ways of searching for and organizing data on adverse events reported to the FDA for many human drug and biologic products.
What is the FDA Adverse Event Reporting System (FAERS) Public Dashboard?
The FAERS Public Dashboard is an interactive application, which enables the user to search and download publicly available information from adverse event reports in FAERS, including adverse event reports submitted voluntarily to FDA for information reported to the FDA by the pharmaceutical industry, healthcare providers and consumers. Information in the dashboard is updated quarterly.
Will MMP retirement adversely affect FDA’s postmarketing safety monitoring program?
No. FDA has a robust postmarketing safety monitoring program that is unrelated to the MMP. The MMP provided information that was not readily available to drug and biologic manufacturers at the time the program was established in 1993. However, now a manufacturer can obtain similar information by using the FAERS Public Dashboard. Additionally, you can request individual case reports, which include a narrative describing the event, by submitting a Freedom of Information Act (FOIA) request. Your request must include the FAERS case numbers.
- General Instructions on How to Make a FOIA Request
- Instructions for Requesting Individual Case Report