FDA’s Drug Safety Priorities for 2023

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On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the drug overdose crisis.

FDA performs postmarketing surveillance and risk evaluations on products to identify new adverse events that were not present in the approval process. New information is investigated and may require changes in prescribing information or modification of a Risk Evaluation and Mitigation Strategy (REMS). CDER’s pharmacovigilance efforts in 2023 included reviews of 15 newly identified safety signals (NISS). One of these NISS was related to naloxone hydrochloride product administration. There were attempts to administer a syringe that had no needle. In response, FDA required changes to carton labeling to include a warning that said, “Needle not included.”

Other safety efforts by CDER include medication error prevention. In 2023, the Prevention of Overdoses and Treatment Errors in Children Taskforce Initiative was a collaboration between public health agencies, professional and private sector organizations, health care advocates, and academic experts “to develop strategies to keep children safe from unintentional medication overdoses.”

FDA’s Sentinel Initiative, which is an active surveillance program that evaluates drug safety, saw completion of pilot projects for the integration of signal identification tools into the agency’s routine pharmacovigilance program. In 2023, analyses were conducted that added to the agency’s approval of Paxlovid to treat COVID-19.

“The Sentinel System has transformed the way [a]gency scientists monitor FDA-regulated medical products. Now one of FDA’s leading evidence-generation platforms that can explore and address regulatory questions posed by review teams, Sentinel serves to advance the science of real-world data (RWD) and real-world evidence (RWE),” the report stated. “By making it possible to analyze emerging risks associated with FDA-regulated medical products and to study medical care more broadly, Sentinel enables the [a]gency to assess medical product safety, describe medical product utilization, and characterize medical events under real-world conditions.”

Impurities and contaminants in medications were also addressed in 2023. A new cross-center program was created that was overseen by the Emerging Impurities and Contaminants Committee (EICC). The program brought together experts from different centers within FDA to develop solutions and guidance. Projects and initiatives were created to improve the response to novel or complex impurities. An EICC Charter was established and met on a regular basis to develop programs to address impurities. A guidance document was published in August 2023 that provided a framework for predicting the mutagenic and carcinogenic potential of nitrosamine drug substance-related impurities.

CDER made efforts in the drug overdose crisis by expanding access to opioid overdose reversal products. The first nonprescription naloxone nasal spray was approved in March 2023, with a generic version approved in July 2023.

“The public health crisis of addiction and overdose continues to persist in our country, with drug overdose deaths reaching more than 106,000 in 2023. As part of our ongoing commitment to address the nation’s overdose crisis, we made changes to the prescribing information of two highly misused drug classes, opioids, and stimulants, to increase safe use and address concerns of nonmedical use, addiction, and overdose,” Patrizia Cavazzoni, director of CDER, said in the report. “We continued to protect the public from impurities and contaminants in medications, including activities to address unexpected impurities; informed the public about product recalls; and worked to improve the overall quality of compounded medications,” she also said in the report.

Source: FDA