When we’re sick, we depend on the Food and Drug Administration to make sure our medicine is safe and effective. That work is a complicated one, and it can take years for new drugs to hit the shelves.
The FDA is working to shorten the approval process and has already begun using artificial intelligence (AI) to speed up reviews. It’s too early to say how well that will work, but Commissioner Marty Makary says he hopes to use AI more broadly across the agency.
During the approval process, the FDA’s Center for Drug Evaluation and Research (CDER) assigns a team of physicians, statisticians, chemists, and pharmacologists to review evidence submitted by pharmaceutical companies. The CDER determines whether the potential drug’s benefits outweigh its risks. If it does, the drug is approved for sale. Afterward, the drug company must test the drug and document that its results are consistent. The FDA also inspects the drug’s facilities.
In a recent analysis of news reports about new drugs in China, we found that information from pharmaceutical companies was the primary source for most news articles on these medicines. The majority of news articles also emphasized the positive aspects of the reported drug while failing to mention any potential risks. This tendency to hide the risk of a new drug may contribute to miscomprehension and hinder accurate health decision making. Furthermore, extensive use of absolute adjectives such as “best” and “only” could mislead readers and lead to miscomprehension of the new drugs’ effects and risks.