FDA officials discuss REMS transparency efforts
BALTIMORE – In an effort to enhance the transparency of Risk Evaluation and Mitigation Strategies (REMS), the US Food and Drug Administration (FDA) has launched a publish an interactive web-based dashboard that allows the public to analyze and visualize REMS data, said Yasmeen Abou-Sayed, a team leader in the division of risk management in the Office of Surveillance and Epidemiology (OSE) in the Center for Drug Evaluation and Research (CDER).Abou-Sayed was discussing some recent updates made to the REMS program at the Drug Information Association on Global Pharmacovigilance and Risk Management Strategies Conference last week.
Congress established REMS in 2007; under the program, FDA requires manufacturers to implement specific safety measures that go beyond drug labeling requirements for certain medications with serious safety concern to ensure the benefits of the drug outweigh the risks.
Abou-Sayed said the dashboard, which was launched in May 2023, uses publicly available REMS data files that are found on the FDA website. The analytics reported in the dashboard are similar to the data available in the FDA Adverse Event Reporting System (FAERS) public dashboard.
Eleven new REMS have been filed since the launch of the dashboard last year; there are currently 67 active REMS out of a total of 312 REMS programs.
The agency anticipates this enhanced transparency will help to stimulate increased awareness and understanding of the REMS programs.
She said another noteworthy development was FDA’s publication of a final guidance on the format and the content of a REMS document. (RELATED: FDA finalizes guidance on REMS format and content, Regulatory Focus, 3 January 2023).
This document can be used in conjunction with a separate guidance REMS document Technical Conformance Guide. Through these documents, FDA seeks to ensure that REMS Document are clear and understandable to stakeholders and have a consistent content and format, and can support submission of REMS document in Structured Product Labeling format, which is required starting December 28, 2022,” said FDA’s announcement.
Abou-Sayed described other efforts that are now in the works to integrate electronic health records into REMS data, this work was also described at the DIA meeting early last week. (RELATED: Official: FDA modernizing pharmacovigilance oversight with AI tools, Regulatory Focus 6 February 2024)
