FDA Announces the Retirement of the MedWatch to Manufacturers Program

by | Aug 7, 2020 | Adamas News

The U.S. Food and Drug Administration has announced the retirement of the MedWatch to Manufacturer Program (MMP) as of 31st July 2020. The program provided participating drug and biologic manufacturers with a means of receiving information from the FDA on serious adverse event reports that are submitted directly to the FDA by voluntary reporters.
Since the introduction of the FDA Adverse Event Reporting System (FAERS) public dashboard in 2017, manufacturers can directly search and download publicly available information from adverse event reports, including those submitted  voluntarily. The dashboard is a highly interactive web-based tool where FAERS data can be accessed in a user friendly fashion and allows manufacturers to obtain information more promptly in comparison to receiving this information via the MMP.
The intention of this tool is to expand the access of FAERS data to the public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers. The dashboard does not provide case narratives; these can be obtained by submitting a Freedom of Information Act (FOIA) request along with the applicable FAERS case numbers.
The MMP retirement will not adversely affect the FDA’s postmarketing safety monitoring program.

For more information, please review the FDA update available via: https://www.fda.gov/safety/reporting-serious-problems-fda/medwatch-manufacturer-program

Riddhi Parikh

ADAMAS Consulting