CDER Outlines Drug Safety Priorities

Regulatory NewsRegulatory News | 08 January 2019 |  By 

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released a new report on drug safety priorities from 2018, offering last year’s valsartan contamination fiasco as a good example of how their safety checks work properly.

CDER’s Office of Surveillance and Epidemiology (OSE) is tasked with maintaining a system that can identify and characterize adverse events and medication errors that may not have arisen in the drug development or approval process. Through October 2018, OSE supported more than 6,000 safety reviews across the office’s four core functions: pharmacovigilance, pharmacoepidemiology, medication error prevention and analysis, and risk management.

As part of this work, FDA collects adverse event reports, medication error reports and product quality complaints in a system known as the FDA Adverse Event Reporting System (FAERS), which then can be further monitored via FDA’s Sentinel System.

“We’ll be sharing more soon about our plans for leveraging the possibilities for the Sentinel System to capture real-world data to help in our safety surveillance framework,” CDER Director Janet Woodcock said in a blog post Tuesday.

As far as the valsartan impurities concerns, FDA lays out the June 2018 to today timeline of how the agency offered updates on the impurity risks.

“FDA continues to investigate and test all ARBs [angiotensin II receptor blockers] for the presence of NDMA and NDEA and is taking swift action when it identifies these impurities at above-acceptable levels,” the agency said.

To date, FDA’s Division of Drug Information has fielded almost 7,500 calls specifically about ARBs affected by NDMA or NDEA. In Fiscal Year 2018, this same staff collectively responded to 63,615 inquiries from the public (44,334 by phone, 1,297 by social media, 17,330 by email and 654 via letters), each an opportunity to help a patient safely use his or her medication.

FDA also detailed its safety surveillance for generic drugs, which includes clinical safety surveillance.
“Additionally, we have taken many steps to strengthen safety measures for compounded drugs, especially in light of the 2012 outbreak of fungal meningitis associated with contaminated compounded drugs,” Woodcock added.

Drug Safety Priorities 2018


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