McGovern student published in JAMA Network Open
A review of evidence supporting the 2022 US Food and Drug Administration’s drug approvals conducted by Amanda Koong, MS, a second-year student at McGovern Medical School has been published in JAMA Network Open.
This study was completed in collaboration with Robert Kaplan, PhD, and Veronica Irvin, PhD, from Stanford University and Oregon State University respectively.
For the research, Koong collected data from the FDA Drug Approvals website and the specific clinical trials that were evaluated to reach each approval in 2022. The team collected data on the number of trials used in each approval, the total number of studies registered, and the number of completed studies with results reported in order to gain a better understanding of trends in the FDA’s drug approval process.
“Overall, our results suggest a trend toward a less rigorous FDA approval process for novel drugs,” Koong said. “This is likely due to the enactment of the 21st Century Cures Act in 2017, which allowed the FDA greater flexibility in drug evaluation in an effort to streamline the approval process.”
According to Koong, the FDA approved 65 percent of drugs based on a single trial in 2022, compared to just 20 percent in 2016. Conversely, in 2016 drugs based on three or more studies were approved 55 percent of the time, while in 2022 that number dropped to 11 percent.
Moving forward, Koong has begun working on two new research projects focusing on the approval process of the FDA, including a new paper focusing on drug approvals from 2017, the first year that the 21st Century Cures Act was established, which has been published in Health Affairs Scholar. Additionally, Koong has begun collecting data from 2015-22 in order to analyze trends of the FDA approval process over a longer period of time.
“Both my coauthors, Dr. Robert Kaplan and Dr. Veronica Irvin, were instrumental in this research,” Koong said. “In particular, Dr. Kaplan served as my primary mentor throughout this project and helped me to understand the impact of this research on healthcare policy.”