Drugs

CDER Wants AI Use in Drug Safety: Attorneys

Speaking on their firm’s The Good Bot podcast, three Troutman Pepper attorneys discuss CDER’s new Emerging Drug Safety Technology Program (EDSTP) and how it can positively transform agency and company postmarketing pharmacovigilance efforts. Kyle Dolinsky told podcast host Brett Mason that the program’s objectives are to (1) identify emerging technologies, (2) evaluate and validate technologies, and (3) implement and integrate new technologies into existing drug safety monitoring systems.

“The program intends to leverage technology such as artificial intelligence/machine learning (AI/ML) and advanced data analytics to improve the detection, assessment, and prevention of adverse drug effects,” he said.

Judith O’Grady, who leads the firm’s FDA regulatory team in its Washington office, said collaboration is important to EDSTP and the agency is inviting companies to meet with CDER to share information on their current use of AI, with a goal of mutual learning. Asked to consider the pros and cons of such a meeting, she suggested there would be no negative impact for companies that have the right experience and expertise.

Dolinsky said he expects FDA to issue guidance on using AI in pharmacovigilance that may lead to regulations requiring the use of AI. While there will be upfront costs in moving to the new technologies, he said, the expectation is that ultimately they will lower monitoring costs.

“The new technologies can transform drug safety by streamlining the manual review of data,” O’Grady concluded. “I can easily see FDA moving to evaluate medical device safety in the same way and also using new technologies on safety signals in the pre-approval context.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome