Stakeholders ask FDA to harmonize adverse events terms with standards orgs

Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well as further clarity around key terms. Their comments are in response to a recent workshop on the topic and documents released by the agency.

Lack of standardization of safety data analysis and visualization, as well as inconsistencies in how adverse events are defined, categorized, analyzed, and presented in marketing applications, has led to concerns about whether safety data is being accurately presented, according to FDA. That concern prompted the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) to develop two documents on the topic.

The first document, titled FDA Medical Queries (FMQ), proposes standardizing preferred terms of adverse events using the Medical Dictionary for Regulatory Activities (MedDRA). The second document, Standard Safety Tables and Figures Integrated Guide, proposes standardized methods to visualize clinical trial safety data in tables and figures.

In September 2022, the FDA held a public workshop titled, Advancing Premarket Safety Analytics Workshop, where the agency presented the two documents and opened a docket for public comment. While the docket remains open until 5 December, several major pharmaceutical manufacturers have already submitted their input.

Amgen asked the FDA to harmonize terms into a single preferred term grouping system with other stakeholders, including the Council for International Organizations of Medical Sciences (CIOMS) and the Maintenance and Support Services Organization (MSSO)’s MedDRA.

“A new grouping system for preferred terms (PTs) that coexists with MedDRA will increase complexity for sponsors conducting clinical trials and submitting marketing applications across multiple regions,” the company said. “Furthermore, a parallel grouping system will impact sponsor activities (e.g., signal detection) throughout development and could affect the accuracy and consistency of analyses sponsors present to regulatory agencies about their products.”

Amgen added that the grouping system currently used by MedDRA could be improved, but rather than establishing a new system altogether the FDA should improve what is already there to avoid drug developers from having to conform to multiple systems.

Drugmakers Eli Lilly, Novo Nordisk, AbbVie and Merck also called for collaboration between the FDA and standards organizations so everyone is on the same page. Merck added that it is important to have standard pooling strategies when developing MedDRA preferred terms to have consistency across FDA reviewers and divisions.

“As these methods begin to be implemented by the Agency, we respectfully suggest that the Agency consider ways to collaborate with stakeholders such as MedDRA, ICH, and CIOMS to consider ways in which the planned standard presented in the FMQ and STF-IG documents might be further developed in a manner that would drive toward global harmonization as much as possible,” according to Merck’s comments.

Stakeholders such as Eli Lilly also supported the clarification of terminology and safety topics such as hypersensitivity, anaphylaxis, self-harm, and psychosis.

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Stakeholders ask FDA to harmonize adverse events terms with standards orgs

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