Body: FDA’s new Adverse Event Monitoring System, or AEMS, will enter a key new phase Thursday (Oct. 1), when drug and biologic manufacturers submitting certain postmarket safety reports electronically will be required to use the newer reporting standard underpinning the system. The agency says AEMS is intended to eventually bring together adverse event reports from across FDA-regulated products, including drugs, vaccines, medical devices, cosmetics, food, tobacco and veterinary products, in a single searchable platform that officials hope will make it easier to identify potential safety problems across different product categories while reducing administrative costs. Former FDA commissioner Marty Makary first announced AEMS in March as part of a broader effort to modernize the agency’s postmarket safety surveillance and replace what he described as fragmented and outdated reporting systems that made safety data harder to access and analyze. FDA said at the time the changes could save the agency millions of dollars annually. The system replaces the FDA Adverse Event Reporting System (FAERS) for drugs and biologics and is intended to eventually consolidate several other reporting systems used across the agency. FDA says AEMS will also serve as a centralized platform for consumer complaints, reports of regulatory misconduct and whistleblower submissions. For now, the change primarily affects manufacturers submitting postmarket safety reports for human drugs, biologics and drug- or biologic-led combination products through FDA’s electronic submission gateway. Those companies will now be required to use a newer international reporting standard intended to make the information submitted to FDA more consistent and easier to review and compare. FDA allowed manufacturers that had not yet transitioned to continue using the older reporting format through Sept. 30. Companies submitting reports through FDA’s separate Safety Reporting Portal do not need to make any changes. The broader overhaul has also raised questions about how FDA will handle the large volume of adverse event information made available through the system. FDA cautions that an adverse event report does not establish that a drug or other product caused the reported problem. Reports can also contain incomplete or duplicate information, concerns that consumer advocates previously told Inside Health Policy could become more significant as FDA moves to make adverse event information available more quickly. FDA says AEMS is intended to address at least some of those concerns by standardizing how reports are submitted and using more advanced tools to process and analyze the information. The agency says the platform will use automated redaction and digitization tools, enhanced analytics and cross-product surveillance to help staff identify trends across different types of regulated products. The drug and biologic transition is only one piece of the broader AEMS rollout. FDA has said other product centers and reporting systems will eventually be moved onto the platform, although the agency has not announced a single deadline for completing that transition across all FDA-regulated products. -- James Jarvis ( jjarvis@iwpnews.com )